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Its regulatory authority covers most food products (other than meat and poultry), human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products for consumers, medical, and occupational use, cosmetics and animal feed. The FDA regulates over $1 trillion of products a year (25% of all money spent in the USA). \'93 The basis for the FDA and the expansion of its powers follow a shift in American economic focus from the pro-industria l growth that dominated the 19th century to the pro-consumer health standards that is a cornerstone of 20th century American economic development.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\fs24\super\kerning0 \chftn }{\fs24\kerning0 }{\kerning0 Zaltman, Haim, \'93 Legal Purpose, Risk Stimulators, and Foreign Investment: A Comparative Legal Analysis of the American and Russian Experiences.\'94 (2001), http://www.iet.ru/guest/zaltman/dis.htm\tab }}}{\fs24 \par \tab The Pure Food and Drug Act of 1906 (1906 Act) was enacted to prevent the manufacture, sale or transportati on of adulterated or misbranded foods, drugs, medicines and liquors. It vested enforcement power in the Bureau of Chemistry, of the U.S. Department of Agriculture. In July 1927, the non-regulatory research functions of the bureau were transferred to a d ifferent segment of the department and the Bureau of Chemistry was renamed as the Food, Drug and Insecticide Administration.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Swann, John P., Ph.D., }{\i\kerning0 History of the FDA}{\kerning0 , FDA History Office (adapted from George Kurian, ed., A Historical Guide to the U.S. Government (New York: Oxford University Press, 1998)), }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/oc/history/historyoffda/fulltext.html" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003900000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f006f0063002f0068006900730074006f00720079002f0068006900730074006f00720079006f0066006600640061002f00660075006c006c0074006500 780074002e00680074006d006c000000e0c9ea79f9bace118c8200aa004ba90b7200000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f006f0063002f0068006900730074006f00720079002f0068006900730074006f00720079006f0066006600640061002f00660075006c 006c0074006500780074002e00680074006d006c000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://www.fda.gov/oc/history/historyoffda/fulltext.html}}}{\kerning0 . }}}{\fs24 That name was eventually reduced to the Food and Drug Administration (FDA) in July1930.}{ \super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id.}}}{\fs24 The FDA was transferred from the U.S. Department of Agriculture to the Federal Security Agency in June 1940.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id.}}}{\fs24 In 1953, the Federal Security Agency was turned into the Department of Health, Education and Welfare (HEW).}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 Wallace F. Janssen, }{ \i\kerning0 The U.S. Food and Drug Law: How It Came; How It Works}{\kerning0 , 35 }{\scaps\kerning0 Food Drug Cosm. L. J}{\kerning0 . 132, 134 (1980).}}}{\fs24 The education aspect of HEW was extricated in May 1980, to form the Depart ment of Health and Human Services, which is where the FDA is currently located.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 Swann, }{\i\kerning0 supra}{\kerning0 note 2.}}}{\fs24 In 1938, Congress passed the Food Drug and Cosmetic Act (FDCA) which partially repealed the 1906 Act. This paper focuses on the expansion of the enforcement powers granted t o the FDA beginning with the 1906 Act, through the FDCA and the subsequent amendments to the FDCA. It also discusses the treatment of FDA\rquote s enforcement functions in courts. \par \tab Congress tends to pass acts expanding the FDA\rquote s regulatory authority following \'93outrageous industry practices, public health tragedies, or significant scientific advances.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Ann Mileur Boeckman, }{\i\kerning0 Comment: An Exercise in Administrative Creativity: The FDA\rquote s Assertion of Jurisdiction Over Tobacco}{\kerning0 , 45 Cath. U. L. Rev. 991, n.1 (Spring, 1996).}}}{\fs24 Prior to the passage of the 1906 Act, the practices of the food industry produced food that was unsafe and tainted.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at n.1, (quoting C.C.Regier, }{\i\kerning0 The Struggle for Federal Food and Drugs Legislation}{\kerning0 , 1 Law & Contemp. Probs. 3, 7-8 (1933) (describing sausages and hamburger steak that contained boracic acid in amounts approaching five to ten times that of a typical medical dosage)).}}}{\fs24 Upton Sinclair\rquote s description of the hideous condition of the meat-packing industry in }{\i\fs24 The Jungle }{\fs24 began a turmoil over tainted meat,}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 James Harvey Young,, }{\i\kerning0 The Pig That Fell Into The Privy: Upton Sinclair\rquote s The Jungle and The Meat Inspection Amendments of 1906}{ \kerning0 , in Bulletin of the History of medicine 59, 467-80 (1985).}}}{\fs24 which was a very important factor in moving Congress to pass a meat inspection law and the 1906 Act.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Swann, }{\i\kerning0 supra}{\kerning0 note 2.}}}{\fs24 \par \tab \par }{\b\fs24\ul ENFORCEMENT POWERS OF THE 1906 FOOD AND DRUG ACT}{\fs24 \par \tab Very few enforcement powers were provided in the 1906 Act to enforce the act. The Act provided the authority to bring legal proceedings against violators of the Act\rquote s provisions.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Pure Food and Drug Act of 1906 Act, Pub. L. No. 59-384, \'a7 5, 34 Stat. 768 (1906) (repealed 1938).}}}{\fs24 These could be brought by any district attorney to whom the Secretary of Agriculture reported any violations of the act.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id.}}}{\fs24 Violations of the provisions against the manufacture, sale and transportation of adulterated food and drugs constituted misdemeanors.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 1 and 2.}}}{\fs24 The Act included the authority to promulgate uniform rules and regulations to enforc e its provisions. It vested this rulemaking authority in the Secretary of the Treasury, the Secretary of Agriculture and the Secretary of Commerce and Labor.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 3.}}}{\fs24 The Act authorized the Bureau of Chemistry to examine specimens of foods and drugs.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 4.}}}{\fs24 Any viola tions found would be reported by the Secretary of Agriculture for prosecution. The act authorized seizure of any article of food, drug or liquor in interstate commerce, or being warehoused after interstate transportation, that was found to be adulterated or misbranded.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 10.}}}{\fs24 Finally, the Act authorized the Secretary of the Treasury to refuse admission into the U.S. any foods or drugs being imported into the U.S., upon a finding by the Secretary of Agriculture that they were adulterated or misbranded.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 11.}}}{\fs24 Further , charges for storage and labor on goods that were refused admission were to be paid by the owner of those goods. A default of such payment was to constitute a lien against any future importation made by such owner.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . }}}{\fs24 \par \tab \par }{\b\fs24\ul SHORTCOMINGS OF THE 1906 FOOD AND DRUG ACT \par }{\fs24 \tab The 1906 Act was ridden with deficiencies in the enforcement powers that it provided for its enforcement.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 Ruth deforest Lamb, American Chamber of Horrors: The Truth About Food and Drugs (New York: Farrar and Rinehart 1936) for an analysis of the substantive shortcomings of the 1906 Act. Ruth De Forest Lamb was FDA\rquote s chief educational officer, who organized consumer support for the FDCA.}}}{\fs24 The original 1906 Act proscribed \'93false or misleading statements on the labels of foods and drugs.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Pub. L. No. 59-384, \'a7 8, 34 Stat. 768 (1906)}}}{\fs24 In the first test case to reach the Supreme Court, }{\i\fs24 Johnson v. U.S.}{\fs24 ,}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ 221 U.S. 488, 506-507 (1911).}}}{\fs24 the Court ruled that the prohibition against false and misleading statements only related to the identity of the product and not to its curative properties.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Lamb, }{\i\kerning0 supra}{\kerning0 note 19, at 12. }}}{\fs24 This ruling encouraged manufacturers who had began to bring their labels into compliance with the 1906 Act to revert to making false therapeutic claims on their product labels.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id.}}}{\fs24 In 1912, Congress enacted the Sherley Amendment to the 1906 Act outlawing false therapeutic claims for patent medicines, but requiring the government to prove that the promoter intended to defraud his victim.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Janssen, }{\i\kerning0 supra}{\kerning0 note 5 at 135. }{\i\kerning0 See also}{\kerning0 The Sherley Amendment, ch. 352, 37 Stat. 416 (1912)}}}{\fs24 The problem with this intent to defraud requirement was that so long as violators demonstrated that they subjectively believed their false curative claims, they could not be proceeded again st.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Janssen at 135}}}{\fs24 This presented a big obstacle to the FDA\rquote s efforts at prosecuting violators, as it meant that the FDA had no real control of the package-medicine industry. Furthermore, since violators of this provision were assessed very light penalties, they seemed to view the penalties as \'93 license fees for carrying on an illegitimate business.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{ \kerning0 Lamb, }{\i\kerning0 supra}{\kerning0 note 19, at ix.}}}{\fs24 \par \tab Another problem with the 1906 Act was that, while it required the listing of certain addictive substances on drug labels, it did not require enough additional information to make those statements meaningful to the average person.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at 81.}}}{\fs24 Thus, drugs taken according to directions could be harmful but out of FDA\rquote s reach. An example of this is a case that the FDA investigated that involved a woman who had taken a headache medicin e made of a coal-tar derivative. She had ingested a powder containing six grains of acetanilid, followed soon afterwards by a similar dose. The average dose of acetanilid prescribed by physicians is three grains. Her death was instantaneous.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at 81-82.}}}{\fs24 The FDA c ould not proceed against the manufacturers of this product, because it was labeled truthfully and the quantity of acetanilid was indicated on the label in accordance with the law. The FDA\rquote s sole recourse was to warn the public about such \'93 remedies\'94 and encourage them to read the labels.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 } {\i\kerning0 Id}{\kerning0 . at 81-82}}}{\fs24 \par \tab Even for products that made false therapeutic claims that the FDA would have no difficulty proving that they were made with fraudulent intent, the manufacturers found a loophole by which they could escape FDA enforcement action. Manufacturers would simply make the curative claims in advertising, rather than making them on the package.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id}{\kerning0 . at 109-114, for a discussion on how the manufacturer of Crazy Water Crystals circumvented the FDA\rquote s enforcement efforts through advertising.}}}{\fs24 This left the FDA with no recourse at all against such products and their manufacturers. \par \tab The 1906 Act authorized the Secretary of the Treasury, the Secretary of Agriculture and the Secretary of Commerce and Labor to make uniform rules and regulations for the enforcement of the Act.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Pub. L. No. 59-384, \'a7 3, 34 Stat. 768 (1906)}}}{\fs24 However, the Act did not authorize the Secretary to establish legal standards for the regulated products, or tolerance standards for poisonous residues in produce, choosing to let courts and juries handle that undertaking.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 Lamb, }{\i\kerning0 supra}{\kerning0 note 19, at 146-147, for a discussion on the food lobby\rquote s successful efforts at preventing the 1906 Act from granting the Secretary of Agriculture authority to establish legal standards.}}}{\fs24 The courts however were not interested in taking up this responsibility.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id.}{\kerning0 at 149, quoting the court\rquote s opinion on determination of the appropriate standard for milk fat in ice-cream, in a case against an Arizona ice-cream manufacturer, \'93 It should not be left, it seems to me, for the decision of the court, but should be determined by Congress or by authorization of the Secretary so that the trade may know...\'94}}}{\fs24 They however did not accord FDA regulations legal effect. A frustrated David F. Houston, Secretary of Agriculture, remarked in his first Annual Report, \par }\pard \ql \li720\ri0\nowidctlpar\nooverflow\faroman\rin0\lin720\itap0 {\fs24 \'93The establishment of legal standards for judging foods would render the food and drugs act more effective, less expensive in its administration, and supply needed legal criteria. Under the present conditions it is necessary in the individual prosecution to establish by evidence a standard for each individual article. This procedure is very expensive, and sometimes its cost is out of proportion to its value. Mor e over, it may result in lack of uniformity in different jurisdictions. With legal standards established, the control of foods would be more uniform and measurably less expensive. The lack of such standards is today one of the greatest difficulties in the administration of the food and drugs act.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{ \i\kerning0 See id}{\kerning0 . at 151, quoting a statement by Secretary David F. Houston in his first Annual Report.}}}{\fs24 \tab \par }\pard \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\fs24 \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\fs24 In 1914 Secretary Houston revived the Food Standards Committee to provide advisory criteria for what constituted economic adulteration forbidden by the 1906 Act.}{ \super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at 154}}}{\fs24 These did not have the force and effect of law and thus the government still had to introduce several witnesses to testify as to the standards expected by consumers and recognized by the reputable majority of the trade.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at 154-155.}}}{\fs24 In1923, Congress enacted a legislation that established a legal standard for butter, for purposes of the enforcement of the1906 Act.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 42 Stat. 1500 (1923) - butter was described as \'93 the food product usually known as butter, and which is made exclusively from milk or cream, or both, with or without common salt, and with or without addit ional coloring matter, and containing not less than 80 per centum by weight of milk fat, all tolerances having been allowed for.\'94}}}{\fs24 Congress is however not the appropriate body for setting legal standards generally for two reasons. First, it is such a tremendous undertaking that no Congress could manage it.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 Lamb, }{\i\kerning0 supra}{\kerning0 note 19 at 147.}}}{ \fs24 Second, technological advances would require changes in the standards from time to time and these could only be effected through Congressional action, a slow process, which would render the standards inflexible.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 The lack of authority to promulgate legal standards was indeed one of the greatest shortcomings of the1906 Act. \par \tab Imitations of certain standard products sold under the name of the standard product were considered misbranded and thus proscribed by the 1906 Act.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Pub. L. No. 59-384, \'a7 8, 34 Stat. 768 (1906).}}}{\fs24 However there was a loophole through which imitation products escaped regulation under the 1906 Act: imitations were exempted from prohibition if they are sold under their own distinctive names, as long as they did not contain any added poisonous or deleterious ingredients.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id.}}}{\fs24 Some of these exempted products even though not poisonous, amounted to economic adulteration.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{ \kerning0 }{\i\kerning0 See}{\kerning0 Lamb, }{\i\kerning0 supra}{\kerning0 note 19 a t 160-161, for a discussion on the economic adulteration worked by the addition of colored soya-bean flour to plain macoroni to change its color so it can look like the more expensive semolina macoroni, to extract more money for it. }}}{\fs24 The 1906 Act had no provision requiring the declaration of these products\rquote ingredients (unless they included addictive substances), in proportion, so that the consumer would have sufficient information on the label to make a well-informed choice. }{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id.}{\kerning0 at 164.}}}{\fs24 \par \tab The 1906 Act authorized the FDA to regulate food that was adulterated because it was filthy, decomposed or had in it any portion of an animal unfit for food.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Pub. L. No. 59-384, \'a7 7, 34 Stat. 768 (1906).}}}{\fs24 Enforcement officials were aware that unsanitary conditions at the manufacturing plants meant that the finished product had to be contaminated.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 Lamb, }{\i\kerning0 supra}{\kerning0 note 19, at 252.}}}{\fs24 They however had no authority to inspect these manufacturing plants. Since their jurisdiction began only when the finished product entered interstate commerce they were limited to examining samples taken from actual interstate shipments.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at 252.}}}{\fs24 The methods available at the time were not sophisticated enough to detect invisible filth.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 A method of micro-analyzing butter was innovated and an examination of butter that looked perfectly clean to the naked eye revealed filth suggesting contamination from way back in the farm: hay, chicken feathers, maggots, beetles, rodent hairs, fly legs, cockroaches, metallic filings, etc.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at 253.}}}{\fs24 Butter that was found to be adulterated in this way was sometimes released for renovating at the discretion of the courts.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at 255.}}}{\fs24 There was}{\fs24\cf6 }{\fs24 a special law regulating the manufacture and sale of renovated butter and oleomargarine.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at 254. 21 U.S.C. \'a7 347 (2003) of the FDCA regulates intrastate sales of colored oleomargarine or colored margarine.}}}{\fs24 The manufacturers of renovated butter or oleomargarine were required to be licensed and to use prescribed labels and containers. The Bureau of Dairy Industry was}{\fs24\cf6 }{\fs24 responsible for the sanitary inspection of these factories. The FDA did not have general inspection authority and it was thus difficult to administer the f ilth provisions of the 1906 Act. In 1934, the Shrimp Amendment to the 1906 Act was passed, authorizing supervisory inspection of the seafood industry for all packers desiring the service.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id}{\kerning0 . at 277, for a brief discussion of the events leading to the passing of the Shrimp Amendment. }{\i\kerning0 See}{\kerning0 }{\i\kerning0 also}{\kerning0 The Shrimp Amendment, 48 Stat. 1204 (1934) (codified as, Pub. L. No. 59-384, \'a7 10A, 34 Stat. 768 (1906)).}}}{\fs24 This inspection was not mandated, but was provided when the shrimp packers applied for it, at the discretion of the Secretary of Agriculture.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 The Shrimp Amendment, 48 Stat . 1204 (1934) (codified as, Pub. L. No. 59-384, \'a7 10A, 34 Stat. 768 (1906)).}}}{\b\fs24\ul \par }{\fs24 \tab A therapeutic disaster in 1937 provided the force that led to the passage of a bill that had been in congress for five years.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Swann, }{\i\kerning0 supra}{\kerning0 note 2.}}}{\fs24 In 1937, a new sulfa wonder drug called Elixir Su lfanilamide was marketed by a Tennessee drug company, the S. E. Massengill Company.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 James Harvey Young,, }{\i\kerning0 Sulfanilamide and Diethylene Glycol}{\kerning0 , in }{\scaps\kerning0 Chemistry and Modern Society: Historical Essays in honor of Aaron J. Ihde, John Parascando la and James C. Whorton, eds}{\kerning0 ., 105-25, 105 (Washington, D.C.: American Chemical Society, 1983). }}}{\fs24 \'93 The solvent in this untested product was a highly toxic chemical analogue of antifreeze that killed over 100 people, many of whom were children.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Swann, }{\i\kerning0 supra}{\kerning0 note 2.}}}{\fs24 This event caused the FDA\rquote s division of pharmacology to conduct research that developed a \'93statistically based method for determining the comparative toxicity of compounds.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Young, }{\i\kerning0 Sulfanilamide and Diethylene Glycol}{\kerning0 , supra note 54 at 105. }}}{\fs24 It was also in the wake of this event that congress passed the Food Drug and Cosmetic Act (FDCA), which was signed on June 25, 1938.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Swann, }{\i\kerning0 supra}{\kerning0 note 2.}}}{\fs24 Once again, this is a demonstration of Congress\rquote passing of a law safeguarding public health only after a therapeutic disaster.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 Swann, }{\i\kerning0 supra}{\kerning0 note 2.}}}{\fs24 \par \par }{\b\fs24\ul ENFORCEMENT POWERS OF THE 1938 FOOD DRUG AND COSMETIC ACT \par }{\fs24 \tab The FDCA provides the FDA with significant enforcement powers and tools for the enforcement of the act.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\kerning0 Federal food, Drug, and Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. \'a7 301-399 (2003)). }}}{\fs24 The Act for the first time in \'a7302 (a) gave U.S. district courts jurisdiction to issue injunctions and restraining orders for the violations of its provisions.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 Pub. L. No. 75-717, \'a7 301, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C. \'a7 331(2003)), for a listing of the FDCA\rquote s prohibited acts.}}}{\fs24 The Act provides the authority to bring legal proceedings to prosecute violations of the provisions listed in \'a7 301.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Pub. L. No. 75-717, \'a7 303, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C. \'a7 333 (2003)).}}}{\fs24 Such violations constitute misdemeanors.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 The fines provided for in the FDCA are much more significant than those that had been provided in the 1906 Act.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 303(a), provided that violators would be subject to imprisonment for not more than one year, or a fine of not more than $1,000, or both . Subsequent violations would subject violators to imprisonment for not more than three years, or a fine of not more than $10,000, or both. While, Pub. L. No. 59-384, \'a7 1, 34 Stat. 768(1906), provided for a fine of not more than $500 or one year imprison ment or both for the manufacture of adulterated food and drugs, while section 2 provided a fine of not more than $200 for the first offense and a fine of not more than $300 or one year imprisonment or both, for subsequent violations of interstate commerce of adulterated goods.}}}{\fs24 Section}{\f3\fs24 \'20}{\fs24 303 (b) further provides that violations committed with an intent to defraud or mislead, are punishable by imprisonment for not more than three years, or a fine of not more than $10,000, or both. Whereas fraud was not a prerequisite for assessing penalti es on violators, where fraud could be proved, higher penalties would be applied. \par \tab The FDCA in \'a7304 (a) provides for the seizure of any food, drug, device or cosmetic in interstate commerce that is adulterated or misbranded. Seized goods are proceeded agai nst on libel of information and condemned in any district court of the U.S. within the jurisdiction where the article was found. In addition, upon entry of a decree of condemnation against the seized goods, \'a7 304 (e) provides that court costs and fees, and storage and other expenses, are to be awarded against the claimant of the goods. In the case of minor violations, the FDA can use its discretion to issue a written notice or }{\kerning0 \par }{\fs24 warning, rather than reporting violations for prosecution.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Pub. L. No. 75-717, \'a7 306, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C. \'a7 336 (2003)). \par }}}{\fs24 \par \tab Most importantly, \'a7401 gave the FDA the authority to promulgate regulations fixing and establishing legal standards for food. This includes establishing \'93 reasonable definitions and standards of identity, reasonable standards of quality and reasonable standards of fill of containers.\'94 Section 404 (a) gives the FDA emergency permit control authority. This applies if the FDA finds that any class of food in interstate commerce has been contaminated with micro-organisms during its manufacture, processing, or packing and that s uch contamination cannot be adequately determined after the articles have entered interstate commerce. In this situation, the FDA is required to promulgate regulations providing for the issuance of permits to the manufacturers, processors, or packers of t hat class of food in the affected locality. The permit would set forth conditions governing the manufacture, processing, or packing of that class of food, for a temporary period of time, as may be necessary to protect the public health. During this time , only permit-holders can manufacture, process or pack this class of food for introduction into interstate commerce. The FDA is authorized under \'a7 404 (b), to suspend immediately upon notice any permit if it is found that any of the conditions of the permit have been violated. The permit can only be reinstated after a hearing and an inspection of the establishment, to assure that adequate measures have been taken to comply with and maintain the conditions of the permit. During this period, permit-holders are required under \'a7 404 (c) to provide FDA officers access to any factory for the purpose of ascertaining whether or not the conditions of the permit are being complied with. Denial of access for such an inspection is a ground for suspension of the permit , until such access is freely given by the operator. \par \tab In situations where a poisonous or deleterious substance is required in the production of a food, or cannot be avoided by good manufacturing practice, \'a7406 (a) gives the FDA authority to promulgate regu lations limiting the quantity of such poison on or in the food to the extent necessary for the protection of the public. A food with any amount of the poison below the tolerance established by the FDA is to be deemed safe, but any quantity of the poison exceeding such tolerance is to be deemed unsafe.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{ \i\kerning0 Id}{\kerning0 . at \'a7 406(a) (codified as amended 21 U.S.C. \'a7 346 (2003)). }}}{\fs24 The FDA was also given the authority to list harmless coal-tar colors suitable for use in food, drugs and cosmetics and also for the certification of batches of such colors.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 For this provision with respect to food, }{\i\kerning0 see}{\kerning0 }{\i\kerning0 id}{ \kerning0 . at \'a7 406(b), 52 Stat. 1040 (1938) (repealed 1960), for drugs, }{\i\kerning0 see}{\kerning0 }{\i\kerning0 id}{\kerning0 . at \'a7 504 (repealed 1960), and for cosmetics, }{\i\kerning0 see}{\kerning0 }{\i\kerning0 id}{\kerning0 . at \'a7 604 (repealed 1960).}}}{\fs24 Section 706 provides that the admitting to listing and certification of coal-tar colors, shall be performed only upon payment of fees that shall be specified in regulations promulgated by the FDA. \par \tab A very important improvement in the FDCA was the elimination of the requirement to prove fraud in the prosecution of manufacturers that made false claims for drugs.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at 502(a) (codified as amended 21 U.S.C. \'a7 352(a) (2003)), simply provided that a drug or device shall be deemed to be misbranded if its labeling is false or misleading in any particular. }}}{\fs24 It now became easier for the FDA to go after manufacturers that made false therapeutic claims for drugs. For the purposes of prosecution under misbranding, not only did the drug labels have to list the ingredients, under \'a7 502 (f), they now had to include adequate directions for use and warnings against use under certain conditions or by children where it would be dangerous. Even more significant was the provision requiring FD A approval of new drugs for safety before they are introduced into interstate commerce.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id}{\kerning0 . at \'a7505 (codified as amended 21 U.S.C. \'a7 355 (2003)).}}}{\fs24 Pre-market approval protected consumers more by preventing violations, rather than merely prosecuting violations after the injuries had occurred.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Wallace F. Janssen, }{\i\kerning0 The Story Of The Laws Behind The labels: Part II, 1938 \endash The FDCA}{\kerning0 , }{\field{\*\fldinst {\kerning0 HYPERLINK "http://vm.cfsan.fda.gov/~lrd/history1a.html" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000002c00000068007400740070003a002f002f0076006d002e0063006600730061006e002e006600640061002e0067006f0076002f007e006c00720064002f0068006900730074006f0072007900310061002e00680074006d006c000000e0c9ea79f9bace118c82 00aa004ba90b5800000068007400740070003a002f002f0076006d002e0063006600730061006e002e006600640061002e0067006f0076002f007e006c00720064002f0068006900730074006f0072007900310061002e00680074006d006c000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://vm.cfsan.fda.gov/~lrd/history1a.html}}}{\kerning0 . }}}{\fs24 Under \'a7505 (e), th e FDA was also given the authority to suspend applications for new drugs already approved when clinical experience and tests by new methods showed the drug to be unsafe, or when the application was later found to contain any untrue statement of a material fact. This is a very important enforcement power, because it allows the FDA to revisit approved applications for new drugs after new technological advances show the approved drugs to be unsafe. \par \tab Other general powers are given to the FDA for the purposes o f enforcement of the FDCA. Section 702 (c) gives the FDA authority to inspect the records of any department or independent establishment in the executive branch of the Government. Also, under \'a7 703, carriers engaged in interstate commerce are required to permit FDA officers to have access to and to copy all records showing the movement in interstate commerce of any food, drugs and cosmetics. Failure to permit such access is unlawful.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Pub. L. No. 75-717, \'a7 703, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. \'a7 373 (2003)).}}}{\fs24 This enables the FDA to be aware when these articles are in interstate commerce and to examine them for compliance. \par \tab More importantly, FDA officers are authorized under \'a7704, upon request and consent, to inspect factories, warehouses and establishments in which food, drugs, devices, or cosmetics are manufactured, processed , packed, or held, for introduction into interstate commerce, or held after such introduction. They are also authorized to inspect any vehicle being used to transport or hold such articles in interstate commerce. The FDA is authorized under \'a7 705 (b) to disseminate information regarding food, drugs, devices, or cosmetics in situations involving, in the opinion of the FDA, imminent danger to health or gross deception of the consumer. Publicity is a very important and effective enforcement tool. }{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 , Richard S. Morey, }{ \i\kerning0 FDA Publicity Against Consumer Products \endash Time for Statutory Revitalization?}{\kerning0 }{\scaps\kerning0 30 Business Lawyer 165}{\kerning0 (November 1974) (discussing FDA\rquote s use of publicity and concluding that the FDA exceeds its statutory bound in exercising its publicity powers).}}}{\fs24 The FDA is also authorized under \'a7 801 (a), to examine samples of food, drugs, devices, and cosmetics which are being imported or offered for import into the U.S. If such samples are found to be adulterated, misbranded, or forbidden or restricted in sale in the coun try in which it was produced or from which it was exported, then the FDA is authorized to refuse such article admission. Furthermore, \'a7 801 (c) provides that all charges for storage and labor on any article which has been refused admission, shall be paid by the owner or consignee. \par \tab The FDCA and the FDA\rquote s regulations do not authorize the FDA to order a recall.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 John M. Packman, }{\i\kerning0 Civil and Criminal Liability Associated With Food Recalls}{\kerning0 53 }{\scaps\kerning0 Food Drug L. J}{\kerning0 . 437 (1998).}}}{\fs24 The FDA however has regulations that set forth its recall policy should a manufacturer decide to recall a product.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 21 C.F.R. \'a7\'a7 7.40 - 7.59 (1997)}}}{\fs24 \'93These recall regulations are guidelines only and do not have the force of law.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Packman, supra note 72, at 439 n.1.}}}{\fs24 If a company refuses to voluntarily recall a violative product, there are no penalties provided by the FDCA or the FDA regulations.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at 439}}}{\fs24 However, that company\rquote s liability would arise from the product\rquote s violations.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{ \kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 The company\rquote s liability from possible class actions and punitive damages can be increased significantly by a refusal to recall a violative product.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 \par \tab Many of the problems of the 1906 Act were solved by the FDCA. The FDA could not only bring le gal proceedings with higher penalties, it could seek injunctions, seize violative goods, establish legal standards for food, establish tolerance levels for poisons in food, exercise emergency permit control authority, pre-approve new drugs, suspend pre-ap proved drugs, inspect factories, refuse admission to violative imported goods, list approved coal-tar colors and certify each batch of such colors for use in food, drugs and cosmetics. Even with this significant expansion of the FDA\rquote s enforcement powers there was still room for improvement. \par \par }\pard \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\b\fs24\ul FURTHER EXPANSION OF FDA ENFORCEMENT POWERS BY THE AMENDMENTS TO THE FDCA \par \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\fs24 \tab Congress later passed amendments to the FDCA further expanding FDA\rquote s enforcement powers. Congress provided for the certification of batches of drugs composed wholly or partly of insulin,}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Act of December 22, 1941, Pub. L. No. 77-366, ch. 613, 55 Stat. 851 (1941) (amending Pub. L. No. 75-717, 52 Stat 1040 (1938)) (repealed 1997).}}}{\fs24 penicillin,}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Act of July 6, 1945, Pub. L. No. 79-139, ch. 281, 59 Stat. 463 (1945) (amending Pub. L. No. 75-717, 52 Stat 1040 (1938)) (repealed 1997).}}}{\fs24 streptomycin,}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Act of March 10, 1947, Pub. L. No. 80-16, ch. 16, 61 Stat. 11 (1947) (a mending Pub. L. No. 75-717, 52 Stat 1040 (1938)) (repealed 1997).}}}{\fs24 chlortetracydine,}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Act of August 5, 1953, Pub. L. No. 83-201, ch. 334, 67 Stat. 389 (1953) (amending Pub. L. No. 75-717, 52 Stat 1040 (1938)) (repealed 1997).}}}{\fs24 chloramphenicol}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Ac of July 13, 1949, Pub. L. No. 81-164, ch. 305, 63 Stat. 409 (1949) (amending Pub. L. No. 75-717, 52 Stat 1040 (1938)) (repealed 1997).}}}{\fs24 and bacitracin.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . }}}{\fs24 The FDCA prohibited poisonous substances in food but required no showing that food ingredients were safe. The FDA could therefo re put an end to the use of poisons it knew of, but did not have adequate resources to carry out research needed to assure that all food chemicals were safe.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Janssen, }{\i\kerning0 supra}{\kerning0 note 69.}}}{\fs24 The problem of chemicals in food produced three amendments: the Pesticide Amendment (1954), the Food Additives Amendment (1958), and the Color Additive Amendments (1960).}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 \par \tab The Pesticide Amendment of 1954 gave the FDA the authority to promulgate regulations establishing tolerances for pesticide chemicals in or on raw agricultural commodities.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{The Pesticide Amendment of 1954}{\kerning0 , Pub. L. No. 83-518, ch. 559, 68 Stat. 511 (1958) (amending Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified as amended 21 U.S.C. \'a7 346a (2003)).}}}{\fs24 This law provided that persons that had registered, or had submitted an application for the registration of an economic poison under the Federal Insecticide, Fungicide and Rodenticide Act, could petition the FDA to promulgate regulations establishing a toleran ce for a pesticide chemical that was a constituent of such economic poison.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \cs17\super \chftn }{ }{\i Id}{. at \'a7 3, adding \'a7 408(d) (codified as amended 21 U.S.C. \'a7 346a (2003)).}}}{\fs24 The FDA was further authorized to charge fees to persons petitioning for the promulgation of regulations setting tolerances for different pesticide chemicals.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 3, adding \'a7 408 (o). (codified as amended 21 U.S.C. \'a7 346a (2003)) }{\i\kerning0 See also}{\kerning0 the Food Quality Protection Act of 1996, Pub. L. No. 104-170, 110 Stat. 1489 (1996) (amending 21 U.S.C. \'a7 346a (2003)), for the procedure and conditions for establishing, modifying, and revoking tolerances and exemptions for pesticide chemical residues.}}}{\fs24 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\fs24 The Food Additives Amendment of 1958 requires FDA approval of food additives for safety.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{The Food Additives Amendment of 1958}{\kerning0 , Pub. L. 85-929, 72 Stat. 1784, (1958) (amending Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified as amended at 21 U.S.C. \'a7 348 (2003)).}}}{\fs24 This law provides that any person intending to use a food additive has to file a petition with the FDA, proposing the issuance of a regulation prescribing the conditions under which such additive may be safely used.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Id. at \'a7 4, adding \'a7 409 (b)(1) (codified at 21 U.S.C. \'a7 348(b)(1) (2003)).}}}{\fs24 This amendment gives the FDA the authority to fix tolerances where a tolerance limitation is required to assure that the proposed use of an additive will be safe.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 Pub. L. No. 75-717, \'a7 409(c)(4), 52 Stat 1040 (1938) (codified as amended 21 U.S.C. \'a7 348(c)(1)(A) (2003)).}}}{\fs24 The amendment however denies the FDA authority to issue tolerance regulations where the food additive in found to induce cancer when ingested by man or animal.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 Pub. L. No. 75-717, \'a7 409(c)(3)(A), 52 Stat 1040 (1938) (codified at 21 U.S.C. \'a7 348(c)(3)(A) (2003)), which provides \'93that no additive shall be deemed to be safe if it found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal.\'94}}}{\fs24 \par The Color Additive Amendments of 1960 require FDA approval of color additives for safety.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{The Color Additive Amendments of 1960}{\kerning0 , Pub. L. No. 86-618, 74 Stat. 397 (amending Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified as amended at 21 U.S.C. \'a7 379e (2003)).}}}{\fs24 The FDA is authorized to list through regulation, color additives for use in food, drugs and cosmetics separately, if such additives are safe for such use.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 103(b), amending \'a7 706 (b)(1) (codified at 21 U.S.C. \'a7 379e(b)(1) (2003)).}}}{\fs24 The FDA is further authorized to provide for the certification of batches of color additives so listed, for compliance with the requirement for such addit ives established by regulation.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{ \kerning0 . at \'a7 103(b), amending \'a7 706 (c) (codified at 21 U.S.C. \'a7 379e(c) (2003)).}}}{\fs24 This amendment, like the Food Additives Amendment, has an anticancer clause, which denies the FDA authority to list for any use, a color additive which is found to induce cancer when ingested by man or animal.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 id. at \'a7 103(b), amending \'a7 706 (b)(5)(B) (codified at 21 U.S.C. \'a7 379e(b)(5)(B) (2003)), which provides \'93that a color additive shall be deemed unsafe...if the additive is found by the FDA to induce cancer when in gested by man or animal, or if it is found by the FDA, after tests which are appropriate for the evaluation of the safety of additives for use in food, to induce cancer in man or animal.\'94}}}{\fs24 \'93With thes e laws on the books, it could be said for the first time that no substance can legally be introduced into the U.S. food supply unless there\rquote s been a prior determination that it is safe.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Janssen, }{\i\kerning0 supra}{\kerning0 note 69. }}}{\fs24 The problem of inadequate resources for research to assure that all food chemicals were safe was solved by requiring the manufacturers to do the research.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\fs24 \tab There was another therapeutic disaster in Europe between 1961 and 1962. Thousands of infants were born deformed to mothers who had taken thalidomide, a new sedative.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Janssen, }{\i\kerning0 supra}{\kerning0 note 5, at 137.}}}{\fs24 Although thalidomide had never been approved in the U.S., these incidents drove Congress to enhance legislation that was pending in Congress and to pass the Drug Amendments of 1962.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Wallace F. Janssen, }{\i\kerning0 The Story Of The Laws Behind The labels, Part III, 1962 Drug Amendments}{\kerning0 , }{\field{\*\fldinst {\kerning0 HYPERLINK "http://vm.cfsan.fda.gov/~lrd/histor1b.html" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000002b00000068007400740070003a002f002f0076006d002e0063006600730061006e002e006600640061002e0067006f0076002f007e006c00720064002f0068006900730074006f007200310062002e00680074006d006c000000e0c9ea79f9bace118c8200aa 004ba90b5600000068007400740070003a002f002f0076006d002e0063006600730061006e002e006600640061002e0067006f0076002f007e006c00720064002f0068006900730074006f007200310062002e00680074006d006c000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://vm.cfsan.fda.gov/~lrd /histor1b.html}}}{\kerning0 . }}}{\fs24 The 1962 Drug Amendments further strengthened the FDCA}{\b\fs24 }{\fs24 by increasing control over prescription drugs, new drugs, and investigational drugs.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Drug Amendments of 1962, Pub. L. No. 87-781, 76 Stat . 780 (1962) (amending Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7\'a7 351, 352, 355, 374 (2003)).}}}{\fs24 The law required all new drugs to be approved by the FDA before being introduced into interstate commerce.}{ \super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 104(a) (codified at 21 U.S.C. \'a7 355(a) (2003)).}}}{\fs24 It requires effectiveness as well as safety before a drug could be approved for marketing.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 102(a) & (b) (codified at 21 U.S.C. \'a7\'a7 321(p), 355(b) (2003)).}}}{\fs24 It transferred the regulation of prescription drug advertising from the Federal Trade Commission (FTC) to the FDA and requires drug advertisements to contain a brief summary relating to side effects, contraindications and effectiveness.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 131(a) (codified at 21 U.S.C. \'a7 352(n) (2003)).}}}{\fs24 The Act required drug manufacturers to conform to good manufacturing practices for the drug industry,}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 101 (codified at 21 U.S.C. \'a7 351(a) (2003)).}}}{\fs24 and required drug companies to establish and maintain records of data relating to clinical experience with respect to their drugs and report such data to the FDA.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 103(a) (codified at 21 U.S.C. \'a7 355(k)(1) (2003)). }}}{\fs24 It also granted the FDA greater powers to access company records.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . (codified at 21 U.S.C. \'a7 355(k)(2) (2003)).}}}{\fs24 It required certification of all antibiotics by the FDA before they could be marketed.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 105 (repealed 1997).}}}{\fs24 The Act authorized the FDA to carry out inspections of factories, warehouses and c onsulting laboratories where prescription drugs are manufactured, processed, packed or held. The inspection authorized extended to all things in the establishments being inspected, as well as records, files papers processes, controls and facilities.}{ \super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id.}{\kerning0 at \'a7 201(a) (codified at 21 U.S.C. \'a7 374(a) (2003)), this inspection does not however extend to \'93financial data, sales data (other than shipment data), pricing data, personnel data (other than data as to qualifications of techni cal and professional personnel performing functions subject to this Act), and research data (other than data relating to new drugs subject to reporting and inspection).}}}{\fs24 \par \tab Since 1962, \'93thousands of prescription drugs have been taken off the U.S. market because they lacked evidence of safety and or effectiveness, or they have had their labels changed to reflect the known medical facts.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Janssen, }{\i\kerning0 supra}{\kerning0 note 100.}}}{\fs24 The requirement of monitoring new drug s for efficacy as well as safety has been criticized for delaying the introduction of new drugs into the market. Economist Sam Peltzman of the University of Chicago conducted a study that concluded that the 1962 amendments had significantly reduced the i ntroduction of effective new drugs from an average of 41.5 annually from 1951-1962, to just 16.1 annually from 1963-1970.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 Sam Peltzman, }{\i\kerning0 An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments}{\kerning0 , }{ \scaps\kerning0 Journal of Political Economy}{\kerning0 , 1049-91, 1053 (Sept - Oct. 1973).}}}{\fs24 Peltzman blames increased clinical testing requirements and more stringent efficacy standards of the 1962 Drug amendments for this \'93d ecline in drug innovation.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{ \kerning0 . at 1089.}}}{\fs24 Other studies have found that the average cost of developing a new drug from discovery to approval has risen from $138 million in the 1970s, to $802 million in the 1990s.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 the }{\i\kerning0 Tufts Center for the Study of Drug Development}{\kerning0 2002 Outlook Report, 2, }{\field{\*\fldinst {\kerning0 HYPERLINK "http://csdd.tufts.edu/InfoServices/OutlookPDFs/Outlook2002.pdf" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003f00000068007400740070003a002f002f0063007300640064002e00740075006600740073002e006500640075002f0049006e0066006f00530065007200760069006300650073002f004f00750074006c006f006f006b0050004400460073002f004f007500 74006c006f006f006b0032003000300032002e007000640066000000e0c9ea79f9bace118c8200aa004ba90b7e00000068007400740070003a002f002f0063007300640064002e00740075006600740073002e006500640075002f0049006e0066006f00530065007200760069006300650073002f004f00750074006c006f 006f006b0050004400460073002f004f00750074006c006f006f006b0032003000300032002e007000640066000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://csdd.tufts.edu/InfoServices/OutlookPDFs/Outlook2002.pdf}}}{\kerning0 . (assessing major drug development issues for the year 2002). }}}{\fs24 The FDA was under pressure particularly from AIDS act ivists, to allow higher levels of risk for new drugs that were intended to treat individuals who were terminally ill, in order to facilitate faster approval of those drugs.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 Daniel Henninger, }{\i\kerning0 Drug Lag,}{\kerning0 in }{ \scaps\kerning0 The Concise Encyclopedia of Economics}{\kerning0 , The Library of Economics and Liberty, }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.econlib.org/library/Enc/DrugLag.html" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003000000068007400740070003a002f002f007700770077002e00650063006f006e006c00690062002e006f00720067002f006c006900620072006100720079002f0045006e0063002f0044007200750067004c00610067002e00680074006d006c000000e0c9 ea79f9bace118c8200aa004ba90b6000000068007400740070003a002f002f007700770077002e00650063006f006e006c00690062002e006f00720067002f006c006900620072006100720079002f0045006e0063002f0044007200750067004c00610067002e00680074006d006c000000}}}{\fldrslt { \cs21\ul\cf2\kerning0 http://www.econlib.org/library/Enc/DrugLag.html}}}{\kerning0 , for the various tactics used by AIDS activists to finally get the FDA to introduce the \'93fast track\'94 approach of approving AIDS drugs.}}}{\fs24 \par \tab In response to the criticism of \'93drug lag,\'94 the FDA introduced \'93\'93fast-track\'94 approval of the AIDS drug AZT, which was cleared for use within two years after it was discovered to be effective against the HIV virus.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 AZT was approved despite its deadliness and the serious side effects observed during clinical trials.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 Since the Prescr iption Drug User Fee Act was passed in 1992, the average combined clinical and approval times for new drugs has dropped by 25% (from 9.2 years to 6.9 years).}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 the Tufts Center for the Study of Drug Development 2003 Outlook Report, 1, }{\field{\*\fldinst {\kerning0 HYPERLINK "http://csdd.tufts.edu/InfoServices/OutlookPDFs/Outlook2003.pdf" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003f00000068007400740070003a002f002f0063007300640064002e00740075006600740073002e006500640075002f0049006e0066006f00530065007200760069006300650073002f004f00750074006c006f006f006b0050004400460073002f004f007500 74006c006f006f006b0032003000300033002e007000640066000000e0c9ea79f9bace118c8200aa004ba90b7e00000068007400740070003a002f002f0063007300640064002e00740075006600740073002e006500640075002f0049006e0066006f00530065007200760069006300650073002f004f00750074006c006f 006f006b0050004400460073002f004f00750074006c006f006f006b0032003000300033002e007000640066000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://csdd.tufts.edu/InfoServices/OutlookPDFs/Outlook2003.pdf}}}{\kerning0 . (assessi ng major drug development issues for the year 2003).}}}{\fs24 Recently, the FDA \'93launched an initiative to further improve the development and availability of innovative medical products.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 the Press release, }{\i\kerning0 FDA Launches Initiative to Improve the Development and Availability of Innovative Medical Products,}{\kerning0 (January 31, 2003), }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/bbs/topics/NEWS/2003/NEW00867.html" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003600000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f006200620073002f0074006f0070006900630073002f004e004500570053002f0032003000300033002f004e0045005700300030003800360037002e00 680074006d006c000000e0c9ea79f9bace118c8200aa004ba90b6c00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f006200620073002f0074006f0070006900630073002f004e004500570053002f0032003000300033002f004e0045005700300030003800360037002e 00680074006d006c000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://www.fda.gov/bbs/topics/NEWS/2003/NEW00867.html}}}{\kerning0 . }}}{\fs24 The initiative is geared towards \'93 making innovative medical technologies available sooner and reducing the costs of developing safe and effective medical products, while maintaining FDA\rquote s traditional high standards of consumer protection.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . }{\i\kerning0 See also}{\kerning0 , }{\i\kerning0 Improving Innovation in Medical Technology: Beyond 2002}{\kerning0 (January 31, 2003), }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/bbs/topics/news/2003/beyond2002/report.html" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003f00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f006200620073002f0074006f0070006900630073002f006e006500770073002f0032003000300033002f006200650079006f006e006400320030003000 32002f007200650070006f00720074002e00680074006d006c000000e0c9ea79f9bace118c8200aa004ba90b7e00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f006200620073002f0074006f0070006900630073002f006e006500770073002f0032003000300033002f 006200650079006f006e00640032003000300032002f007200650070006f00720074002e00680074006d006c000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://www.fda.gov/bbs/topics/news/2003/beyond2002/report.html}}}{\kerning0 , for a report containing an outline of FDA \rquote s proposed actions.}}}{\fs24 \par \tab Around 1960, there was publicity involving the abuse of depressant and stimulant drugs in the U.S. An official report stated that 852,000 pounds of barbiturates had been produced in 1960. This meant that there were thirty-three one-gra in capsules for each person in the U.S.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Rufus King, }{ \i\kerning0 The Drug Hang Up, America's Fifty-Year Folly}{\kerning0 , ch, 26, Drug Abuse Control, 1965. }{\scaps\kerning0 Schaffer Library of Drug Policy}{\kerning0 . }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.druglibrary.org/special/king/dhu/dhu26.htm" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003600000068007400740070003a002f002f007700770077002e0064007200750067006c006900620072006100720079002e006f00720067002f007300700065006300690061006c002f006b0069006e0067002f006400680075002f0064006800750032003600 2e00680074006d000000e0c9ea79f9bace118c8200aa004ba90b6c00000068007400740070003a002f002f007700770077002e0064007200750067006c006900620072006100720079002e006f00720067002f007300700065006300690061006c002f006b0069006e0067002f006400680075002f00640068007500320036 002e00680074006d000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://www.druglibrary.org/special/king/dhu/dhu26.htm}}}{\kerning0 . }}}{\fs24 In 1961, there were claims that tranquilizers were competing with barbiturates as suicide drugs.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 It was revealed and publicized, that the pilot of a plane that had crashed had been taking tranquilizers, and that benzedrine was probably involved in causing a multiple-car accident on the New Jersey Turnpike.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 The sentiment was that there was widespread abuse of barbiturates and other sedatives, stimulants, and tranquilizers. In January 1965, President Johnson urge d Congress to expedite "legislation to bring the production and distribution of barbiturates, amphetamines, and other psychotic drugs under more effective control."}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 A bill addressing this issue had already been introduced in the legislature and resulted in the Drug Abuse Control Amendments of 1965. These amendments were passed to \'93establish special controls for depressant, stimulant and counterfeit drugs.\'94}{ \super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{Drug Abuse Control Amendments of 1965}{\kerning0 , Pub. L. No. 89-74, 79 Stat. 226-235 (1965) (amending Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7\'a7 331(i), 351-360 (2003)).}}}{\fs24 They authorized the FDA to promulgate regulations designating any drug that it found to have a potential for abuse because of its depressant, stimulant or hallucinogenic effect, as a \'93depressant or stimulant drug.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 3(a).}}}{\fs24 Such drugs can only be manufactured or processed by specified persons,}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 3(b), adding \'a7 511(a) (repealed 1970).}}}{\fs24 who have to register,}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 4 (b), adding \'a7 510(b) (repealed 1970). }}}{\fs24 keep records,}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 3(b), adding \'a7 511(d)(1) (repealed 1970).}}}{ \fs24 and are subject to FDA inspection.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{ \i\kerning0 Id}{\kerning0 . at \'a7 3(b), adding \'a7 511(d)(2)(A) (repealed 1970).}}}{\fs24 An FDA Bureau of Drug Abuse Control was formed in 1965. This bureau conducted undercover drug investigations and enabled the prosecution and \'93 conviction of hundreds of racketeers and pushers.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Janssen, }{\i\kerning0 supra}{\kerning0 note 100.}}}{\fs24 In 1968, this bureau was transferred to the Federal Bureau of Narcotics in the Department of Justice.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 Congress also found that there had been significant traffic in counterfeit drugs that posed a considerable risk to the public health.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\kerning0 Pub. L. No. 89-74, \'a7 9(a), 79 Stat. 226-235 (1965}{).}}}{\fs24 Congress recognized that while such drugs were considered misbr anded under the FDCA, it was difficult to determine \'93the place for interstate origin of such drugs and, if that place is discovered, the fact that the implements for counterfeiting are not subject to seizure\'94 meant that there was a need for more effective controls of these drugs regardless of their interstate or intrastate origins.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i Id}{.}}}{\fs24 This law makes it a crime to make, sell, possess or conceal any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, on any drug or container or labeling thereof, so as to cause such drug to be a counterfeit drug.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i Id}{. at \'a7 9(c)(2).}}}{\fs24 This therefore means that counterfeit drugs can be seized for misbranding and possession of instruments used to counterfeit can be proceeded against as a prohibited act. \par \tab Prior to 1968, there was a very inefficient and cumbersome system for the regulation of animal drugs. Animal drugs were governed by one of or a combination of the new drug law, the antibiotic law and the food additive law.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Eugene I. Lambert, }{\i\kerning0 The Reformation of Animal Drug Law: The Impact of 1996}{\kerning0 , }{\scaps\kerning0 Food and Drug Law Journal}{\kerning0 , vol. 52, 277 (1997), }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fdli.org/pubs/Journal%20Online/52_3/3art.pdf" }{ \kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003800000068007400740070003a002f002f007700770077002e00660064006c0069002e006f00720067002f0070007500620073002f004a006f00750072006e0061006c002500320030004f006e006c0069006e0065002f00350032005f0033002f0033006100 720074002e007000640066000000e0c9ea79f9bace118c8200aa004ba90b6c00000068007400740070003a002f002f007700770077002e00660064006c0069002e006f00720067002f0070007500620073002f004a006f00750072006e0061006c0020004f006e006c0069006e0065002f00350032005f0033002f00330061 00720074002e007000640066000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://www.fdli.org/pubs/Journal%20Online/52_3/3art.pdf}}}{\kerning0 . }}}{\fs24 This involved \'93 three separate statutory provisions; three separate administrative procedures and; three separate parts of the [FDA]\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 The Animal Drug Amendments of 1968 combined these three regulatory systems into a unified process for the approval of animal drugs.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 The FDA established the Bureau of Veterinary Medicine, today, the Center for Veterinary Medicine, to carry out animal drug approval. This center however only received \'93full authority over both human and animal aspects of animal drug approvals\'94 in 1983.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at 277 n.11.} }}{\fs24 The Animal Drug Amendments of 1968 were passed to assure the safety and effectiveness of new animal drugs.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ The Animal Drug Amendments of 1968}{\kerning0 , Pub. L. No . 90-399, 82 Stat. 342 (1968) (amending Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7\'a7 351-360 (2003)).}}}{\fs24 The amendments mandate FDA approval of new animal drugs and animal feed containing a new animal drug, before they can be introduced into interstate commerce.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i Id}{. at }{\kerning0 \'a7 101(b), adding \'a7 512(a) (codified at 21 U.S.C. \'a7 360b(a) (2003)). }}}{\fs24 They also authorize the FDA to suspend approved applications if the drug presents an \'93imminent hazard\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 101(b), adding \'a7 512(e)(1)(E) (codified at 21 U.S.C. \'a7 360b(e)(1)(E) (2003)).}}}{\fs24 or withdraw approved applications if the applicant fails to maintain required records}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id}{\kerning0 . at \'a7 101(b), adding \'a7 512(l) (codified at 21 U.S.C. \'a7 360b(l) (2003)), for record-keeping requirements for new animal drugs and Section 512(m)(5) for record-keeping requirements for animal feed containing a new animal drug.}}}{\fs24 or make required reports to the FDA.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id}{\kerning0 . at \'a7 101(b), adding \'a7 512 (e)(2)(A) (codified at 21 U.S.C. \'a7 360b(e)(2)(A) (2003)), for more reasons why the FDA may withdraw approved applications, see Section 512 (e).}}}{\fs24 The FDA is also authorized to certify \'93 batches of new animal drugs composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin or any derivative thereof.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 101 (b), adding \'a7 512 (n)(1) (repealed 1988).}}}{ \fs24 \par \tab In order to facilitate more effective regulation of drugs, the FDA created two voluntary programs in an effort to compile a \'93comprehensive drug inventory for drug listings.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 }{\i\kerning0 Drug Registration and Listing System}{ \kerning0 , }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/cder/handbook/druglist.htm" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000002e00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f0063006400650072002f00680061006e00640062006f006f006b002f0064007200750067006c006900730074002e00680074006d000000e0c9ea79f9ba ce118c8200aa004ba90b5c00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f0063006400650072002f00680061006e00640062006f006f006b002f0064007200750067006c006900730074002e00680074006d000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://www.fda.gov/cder/handbook/druglist.htm}}}{\kerning0 . }}}{\fs24 Following the failure to accomplish this task through the voluntary programs, the FDA passed regulations pursuant to the Drug Listing Act of 1972, to make drug listing mandatory.}{ \cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ The Drug Listing Act of 1972, Pub. L. No. 92-387, 86 Stat. 560-562 (1972) (amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified at 21 U.S.C. \'a7 360(j) (2003)).}}}{\fs24 The Act authorizes the FDA to require all registered drug manufacturers to submit a list of all the drugs they manufacture and market.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Id. at \'a7 3, adding \'a7 510(j)(1) (codified at 21 U.S.C. \'a7 360(j)(1)).}}}{\fs24 In addition, it requires them to report twice a year in June and December, a list of all drugs introduced by the registrant since the last list filed, give a notice of discontinuance of a drug and of resumption of a previously discontinued drug.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Id. at \'a7 3, adding \'a7 510(j)(2) (codified at 21 U.S.C. \'a7 360(j)(2)).}}}{\fs24 \par \tab Title V of the Health Research and Health Services Amendments of 1976 authorizes the FDA, through a U.S. attorney, to bring suit against the manufacturer of a food that is misbranded due to its advertising, if the FTC declines to bring such action.}{ \super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Act of April 22, 1976, Pub. L. No. 94-278, Title V, \'a7 707, 90 Stat 412 (1976) (codified at 21 U.S.C \'a7 378 (2003)).}}}{\fs24 In addition to the FDA\rquote s enforcement power with respect to false and misleading advertising of drugs,}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 }{\i\kerning0 supra}{\kerning0 note 101. }}}{\fs24 it can now proceed against false and misleading advertising of food. \par \tab Technological advances had increased the number and complexity of medical devices. These advances improved medical care significantly.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Statement by Michael Friedman, M.D., Lead Deputy Commissioner of the FDA, before the U.S. House of Representatives Subcommittee on Health and th e Environment Committee on Commerce (April 30, 1997), }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/ola/1997/devices.htm" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000002800000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f006f006c0061002f0031003900390037002f0064006500760069006300650073002e00680074006d000000e0c9ea79f9bace118c8200aa004ba90b5000 000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f006f006c0061002f0031003900390037002f0064006500760069006300650073002e00680074006d000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://www.fda.gov/ola/1997/devices.htm}}}{\kerning0 . }}}{\fs24 However, there were also many complications involving medical devices: \'93 mechanical failure, faulty design, poor manufacturing quality, adverse effects of materials implanted in the body, improper maintenance/specifications, user error, compromised sterility/shelf life and electromagnetic interference among devices.\'94}{ \super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id.}}}{\fs24 The Cooper Commission reported in 1970 that medical devices had caused, or were involved in more than 700 deaths and 10,000 injuries.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id.}}}{\fs24 Congress, then passed the Medical Device Amendments of 1976 further increasing FDA\rquote s enforcement authority with respect to medical devices, and to ensure the safety and effectiveness of medical devices intended for human use.}{\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{The Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539-583 (1976) (amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7\'a7 360c - 360k (2003)).}}}{\fs24 The law authorizes the FDA to classify medical devices into three categories:}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2, adding \'a7 513 (b)(1) (codified as amended 21 U.S.C \'a7 360c(b)(1) (2003)). See the rest of \'a7 513(b) for the process the FDA has to follow in classifying and reclassifying medical devices.}}}{\fs24 class I devices subject only to general controls;}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id}{\kerning0 . at \'a7 2, adding \'a7 513 (a)(1)(A) (codified as amended 21 U.S.C \'a7 360c(a)(1)(A) (2003)), for the conditions necessary for a drug to be classified under class I}}}{\fs24 class II devices subject to performance standards and;}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 See }{\i\kerning0 id}{\kerning0 . at \'a7 2, adding \'a7 513(a) (1)(B) (codified as amended 21 U.S.C \'a7 360c(a)(1)(B) (2003)), for the conditions necessary to for a drug to be classified under class II.}}}{\fs24 class III devices subject to premarket approval.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id.}{\kerning0 at \'a7 2, adding \'a7 513(a)(1)(C) (codified as amended 21 U.S.C \'a7 360c(a)(1)(B) (2003)), for the conditions necessary to for a drug to be classified under class III.}}}{\fs24 The FDA is authorized to prescribe regulations setting forth the basis for determining and authorizing the effectiveness of a medical device.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2, adding \'a7 513(a)(2) (codified as amended 21 U.S.C \'a7 360c(a)(2) (2003)).}}}{\fs24 It is authorized to promulgate regulations establishing performance standards for class II devices,}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2, adding \'a7 514(a)(1) (codified as amended 21 U.S.C \'a7 360d(a)(1) (2003)). }{\i\kerning0 See also}{ \kerning0 \'a7 514 for the rules setting forth the procedure for setting performance standards. }}}{\fs24 and can also amend or revoke them.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id.}{\kerning0 at \'a7 2, adding \'a7 514(g)(4)(A) (codified as amended 21 U.S.C \'a7 360d(b)(4)(A) (2003)). }}}{\fs24 The amendments also authorize the FDA to prescribe regulations requiring premarket approval of class III devices,}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id.}{\kerning0 at \'a7 2, adding \'a7 515(b)(1)(B) (codified as amended 21 U.S.C. \'a7 360e(b)(1)(B) (2003)). }{\i\kerning0 See also}{ \kerning0 the Section 515 for the premarket approval requirements.}}}{\fs24 and to withdraw approval of applications already given where certain conditions are present.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id.}{\kerning0 at \'a7 2, adding \'a7 515(e)(1) (codified as amended 21 U.S.C. \'a7 360e(e)(1) (2003)), for the conditions that if present, allow the FDA to withdraw approval of an application.}}}{\fs24 \par \tab In keeping with the FDA\rquote s mission to safeguard the public health, the Medical Device Amendments of 1976 also authorize the FDA to promulgate regulations banning a device if it \'93 presents substantial deception or an unreasonable and substantial risk of illness or injury.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2, adding \'a7 516(a) (codified at 21 U.S.C. \'a7 360f(a) (2003)).}}}{\fs24 In addition, the FDA is authorized to prescribe regulations conditioning the sale, distribution and use of a medical device upon authorization of a licensed practitioner if it determines that \'93 there cannot otherwise be reasonable assurance of its safety and effectiveness.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id}{\kerning0 . at \'a7 2, adding \'a7 520(e) (codified as amended 21 U.S.C. \'a7 360j(e) (2003)), such devices are referred to as \'93restricted devices.\'94}}}{\fs24 The amendments also require manufacturers of medical devices to register}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 Id. at \'a7 4(a), Section 510 (codified as amended 21 U.S.C. \'a7 360 (2003)). }}}{\fs24 with the FDA, to establish and maintain records and make reports that the FDA may require of them through regulations.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2, adding \'a7 519(a) (codified as amended 21 U.S.C. \'a7 360i(a) (2003)).}}}{\fs24 They authorize the FDA to inspect facilities where medical devices are manufactured,}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 6(a), \'a7 704 (a) (codified as amended 21U.S.C. \'a7 374(a) (2003)). }}}{\fs24 and give it access to records that it requires them to keep.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{ \kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 6(e) (codified as amended 21U.S.C. \'a7 374(e) (2003)). }}}{\fs24 The FD A is also authorized to promulgate regulations setting forth good manufacturing practice for the medical device industry, to assure the safety, effectiveness and compliance of the devices with the FDCA as amended.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2, \'a7 520(f)(1)(A) (codified at 21 U.S.C. \'a7 360j(f)(1)(A) (2003)).}}}{\fs24 To ensure the effectiveness of FDA\rquote s regulation of medical devices, the amendments provide that FDA regulations preempt any state regulation of medical devices.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2, \'a7 521(a) (codified at 21 U.S.C. \'a7 360k(a) (2003)).}}}{\fs24 The Act gives the FDA the authority to make exemptions from this provision if a state requirement is more stringent than an FDA requirement and is required by compelling local conditions.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2, \'a7 521(b) (codified at 21 U.S.C. \'a7 360k(b) (2003)).}}}{\fs24 \par \tab The Safe Medical Devices Act of 1990 was passed further improve the regulation of medical devices.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ The Safe Medical Devices Act of 1990, Pub. L. No. 101-629, 104 Stat. 4511-4529 (1990) (amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7\'a7 360c \endash 360l (2003)).}}}{\fs24 This Act requires \'93device user facilities\'94 to report to the FDA if they reasonably believe that a device caused or contributed to the death, serious illness or injury of a patient of the facility.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2(a), adding \'a7 519(b)(1) (codified as amended 21 U.S.C. \'a7 360i(b)(1) (2003)).}}}{\fs24 The Act further requires registered manufacturers of medical devices that are permanently implantable, or life sustaining (and any others that the FDA may designate), to adopt a method of \'93device tracking\'94 to trace these devices to the user level, and to conduct \'93postmarket surveillance\'94 to monitor products that have been introduced into commerce.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id}{\kerning0 . at \'a7 3(b)(1), adding \'a7 519(e) (codified as amended 21 U.S.C. \'a7 360i(e) (2003)), for \'93device tracking\'94 requirements, and }{\i\kerning0 id}{\kerning0 . at \'a7 10, adding \'a7 522, (codified as amended 21 U.S.C \'a7 360l (2003)), for \'93postmarket surveillance requirements. }}}{\fs24 This Act changed class II devices from being subject to per formance standards, to being subject to \'93special controls,\'94 which include performance standards.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 5(a)(2) (codified as amended 21 U.S.C \'a7 360c(a)(1)(B) (2003)), special controls also include \'93 postmarket surveillance, patient registries, development and dissemination of guidelines...and other appropriate actions\'94 deemed necessary by the FDA, to assure safety and effectiveness. }}}{\fs24 Most importantly this Act gives the FDA the authority to issue orders requiring immediate cessation of distribution and use of a device that it finds would \'93cause serious adverse health consequences or death.\'94 Further, if after an informal hearing the FDA finds that adequate grounds exist to support the order, it can amend the order to require a recall of the device.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 8 (codified as amended 21 U.S.C \'a7 360h(e) (2003)). }}}{\fs24 The Act also authorized the FDA to exempt \'93devices designed to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the U.S.,\'94 from the effectiveness requirements of the FDCA as amended.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id.}{\kerning0 at \'a7 14, adding \'a7 520(m)(2) (codified as amended 21 U.S.C \'a7 360j(m)(2) (2003)), for the conditions necessary to obtain such a \'93humanitarian device exemption.\'94}}}{\fs24 \par \tab There was another crisis in 1978 when one of the big infant formula manufacturers stopped adding salt to two of its soy products.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Food Advisory committee Meeting on Infant Formula}{\kerning0 , }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/OHRMS/DOCKETS/ac/02/briefing/3852b1_01.pdf" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003e00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f004f00480052004d0053002f0044004f0043004b004500540053002f00610063002f00300032002f006200720069006500660069006e0067002f003300 380035003200620031005f00300031002e007000640066000000e0c9ea79f9bace118c8200aa004ba90b7c00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f004f00480052004d0053002f0044004f0043004b004500540053002f00610063002f00300032002f00620072 0069006500660069006e0067002f003300380035003200620031005f00300031002e007000640066000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://www.fda.gov/OHRMS/DOCKETS/ac/02/briefing/3852b1_01.pdf}}}{\kerning0 . }}}{\fs24 These reformulated infant formula products ended up having insufficient amounts of chloride, which is an important nutrient for the growth and development of infants. \'93By mid-1979, a substantial nu mber of infants had been diagnosed with hypochloremic metabolic alkalosis, a syndrome associated with chloride deficiency.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 A connection was found between this condition and the protracted use of the reformulated soy formula.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 Congress then passed the Infant Formula Act of 1980 to assure the safety and nutrition of infant formulas.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ The Infant Formula Act of 1980, Pub. L. No. 96-359, 94 Stat. 1190-1193 (1980) (amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7 350a (2003)).}}}{\fs24 The Act lists the nutrients and amounts of which must be contained in an infant formula.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id}{\kerning0 . at \'a7 2, adding \'a7 412(g) (codified as amended 21 U.S.C. \'a7 350a(i) (2003)).}}}{\fs24 It authorizes the FDA to revise the list of nutrients and the required level for the nutrients listed in the Act.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2, adding \'a7 412(a)(2) (codified as amen ded 21 U.S.C. \'a7 350a(i)(2) (2003)).}}}{\fs24 It also authorizes the FDA to establish quality control procedures, which include the periodic testing of infant formulas for compliance with the Act.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . }}}{\fs24 Manufacturers of infant formula are also required to keep records of distribution of the infant formula, to facilitate recalls of the formula when necessary.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2, adding \'a7 412(e) (codified as amended 21 U.S.C. \'a7 350a(g) (2003)).}}}{\fs24 In the 1986 amendments to this Act, the FDA is authorized to promulgate regulations setting forth good manufacturing practices and quality control procedures.}{\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Act of October 27, 1986, Pub. L. No. 99-570, \'a7 4014(a)(7), adding \'a7 412(b)((2)(B) 100 Stat 3207-116 (1986) }{(amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified at 21 U.S.C. \'a7 350a(b)(2)(B) (2003)), these quality control procedures include: testing each nutrient premix to assure compliance with the certifications of such premix by a premix supplier; testing each batch of inf ant formula for each required nutrient by manufacturers before distribution and ; regularly scheduled testing for each required nutrient by manufacturers during the shelf life of the infant formula.}}}{\fs24 \par \tab In 1982, there was a tragic incident that involved the sudden deaths of seven people in Chicago that had ingested tylenol capsules that had been laced with cyanide. The capsules had been placed in six different stores by an unknown person.}{ \cs17\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i The Tylenol Murders}{, }{\field{\*\fldinst { HYPERLINK "http://www.personal.psu.edu/users/w/x/wxk116/tylenol/" }{{\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003600000068007400740070003a002f002f007700770077002e0070006500720073006f006e0061006c002e007000730075002e006500640075002f00750073006500720073002f0077002f0078002f00770078006b003100310036002f00740079006c006500 6e006f006c002f000000e0c9ea79f9bace118c8200aa004ba90b6c00000068007400740070003a002f002f007700770077002e0070006500720073006f006e0061006c002e007000730075002e006500640075002f00750073006500720073002f0077002f0078002f00770078006b003100310036002f00740079006c0065 006e006f006c002f000000}}}{\fldrslt {\cs21\ul\cf2 http://www.personal.psu.edu/users/w/x/wxk116/tylenol/}}}{. }{\fs24 }}}{\fs24 This act was dubbed \'93product tampering.\'94}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i Id}{.}{\fs24 }}}{\fs24 The FDA responded to this tragedy by issuing regulations prescribing tamper-resistant packaging requirements for all over-the-counter (OTC) drug products and certain cosmetic products.}{\cs17\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i Packaging Regulations}{, }{\field{\*\fldinst { HYPERLINK "http://www.polybottle.com/Pages/Filling/PackagingRegulations.html#TAMPER-RESISTANT%20PACKAGING%20REGULATIONS" }{{\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b020000001f0000006d00000068007400740070003a002f002f007700770077002e0070006f006c00790062006f00740074006c0065002e0063006f006d002f00500061006700650073002f00460069006c006c0069006e0067002f005000610063006b006100670069006e006700 52006500670075006c006100740069006f006e0073002e00680074006d006c002300540041004d005000450052002d0052004500530049005300540041004e0054002500320030005000410043004b004100470049004e00470025003200300052004500470055004c004100540049004f004e0053000000e0c9ea79f9bace 118c8200aa004ba90b8400000068007400740070003a002f002f007700770077002e0070006f006c00790062006f00740074006c0065002e0063006f006d002f00500061006700650073002f00460069006c006c0069006e0067002f005000610063006b006100670069006e00670052006500670075006c00610074006900 6f006e0073002e00680074006d006c0000002b000000540041004d005000450052002d0052004500530049005300540041004e0054002500320030005000410043004b004100470049004e00470025003200300052004500470055004c004100540049004f004e0053000000}}}{\fldrslt {\cs21\ul\cf2 http://www.polybottle.com/Pages/Filling/PackagingRegulations.html#TAMPER-RESISTANT%20PACKAGING%20REGULATIONS}}}{. }}}{\fs24 These regulations require that such product packages provide visual evidence of package tampering and a statement informing the consumer about the tamper-resistant feature.}{\cs17\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i See}{ 21 CFR 211.132(a).}}}{\fs24 The regulations provide that OTC drug products not packaged in a tamper resistant package that are offered for retail sale wi ll be considered adulterated under the FDCA.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i See }{ 21 CFR 211.132(a).}}}{\fs24 Congress also passed the Federal Anti Tampering Act of 1983.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ The Federal Anti Tampering Act of 1983, Pub. L. No. 98-127, 97 Stat. 831 (1983) (codified at 18 U.S.C. \'a7 1365 (2003)).}}}{\fs24 While this Act is not an amendment to the FDCA, it authorizes the FDA and the Department of Agriculture to investigate violations of its provisions.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i Id}{. at \'a7 2, adding \'a7 1365(f) (codified at 18 U.S.C. \'a7 1365(g) (2003)).}}}{\fs24 The Act principally makes tampering with consumer product a crime and provides for various fines and prison terms for: attempting to tamper and actual tampering;}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i Id}{. at \'a7 2, adding \'a7 1365(a) (codified at 18 U.S.C. \'a7 1365(a) (2003)). }}}{\fs24 knowingly communicating false information that a consumer product has been tampered;}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i Id}{. at \'a7 2, adding \'a7 1365 (c) (codified at 18 U.S.C. \'a7 1365(c) (2003)). }}}{\fs24 threatening to tamper in circumstances in which a threat may reasonably be expected to be believed, and;}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i Id}{. at \'a7 2, adding \'a7 1365 (d) (codified at 18 U.S.C. \'a7 1365(d) (2003)).}}}{\fs24 conspiring to tamper plus any conduct in furtherance of such tampering.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \cs17\super \chftn }{ }{\i Id}{. at \'a7 2, adding \'a7 1365 (e) (codified at 18 U.S.C. \'a7 1365(e) (2003)).}}}{\fs24 While product tamperings have decreased, there has still been a few incidents of product tampering throughout the country.}{ \cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i The Tylenol Murders}{ }{\i supra}{ note 188, later product tamperings that resulted in deaths included, \'93Lipton Cup-A-Soup in 1986, Exedrin in 1986, Tylenol again in 1986, Sudafed in 1991, and Goody's Headache Powder in 1992.\'94}}}{\fs24 \par \tab Before the 1980s, there were very few drugs for rare diseases, \'93orphan drugs.\'94 There had not been adequate development of drugs for such rare diseases because the cost of developing the drugs is extremely high in relation to the sales of the drugs.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 John Henkel, }{\i\kerning0 How TV Launched The Orphan Drug Law}{\kerning0 , }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/fdac/features/1999/399_orph.html" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003400000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f0066006400610063002f00660065006100740075007200650073002f0031003900390039002f003300390039005f006f007200700068002e0068007400 6d006c000000e0c9ea79f9bace118c8200aa004ba90b6800000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f0066006400610063002f00660065006100740075007200650073002f0031003900390039002f003300390039005f006f007200700068002e00680074006d006c 000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://www.fda.gov/fdac/features/1999/399_orph.html}}}{\kerning0 . (John Henkel is a staff writer for FDA Consumer). }}}{\fs24 Jack, Klugman, an actor in a hit TV medical drama, \'93Quincy,\'94 is recognized as part of the driving force that increased public awareness of the orphan drug problem. Klugman used his show to publicize this problem, at one time airing an \'93 episode...mirroring the real-life holdup of the [orphan drug] bill taking place on Capitol Hill.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 This created widespread support that resulted in the passage of the Orphan Drug Act of 1983.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 This Act was passed to encourage the development of orphan drugs.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{The Orphan Drug Act of 1983}{\kerning0 , Pub. L. No. 97-414, 96 Stat. 2049 (1983) }{(amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7\'a7 360aa \endash 360ee (2003)).}}}{\fs24 The act amends several laws, including the internal revenue code, in order to create incentives for the development of orphan drugs. The Act authorizes the FDA to provide recommendations upon request, for the non-clinica l and clinical investigations that have to be conducted with an orphan drug before it is approved for the disease it is meant to treat.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2(a), adding \'a7 525(a) (codified at 21 U.S.C \'a7 360aa(a) (2003)).}}}{\fs24 The FDA is authorized to designate a drug, upon the request of the drug manufacturer, as a drug for a rare disease.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2(a), adding \'a7 526(a)(1) (codified at 21 U.S.C \'a7 360bb(a)(1) (2003)). }{\i\kerning0 Id}{\kerning0 . at \'a7 527(b) (codified at 21 U.S.C \'a7 360cc(b) (2003)), provides that the FDA shall not approve a drug application for an orphan drug for seven years after it has already approved an orphan drug treating the same medical condition the new orphan drug proposes to treat, unless the first applicant consents, or cannot pr oduce enough of the drug to meet the needs of those with the rare disease.}}}{\fs24 The FDA is authorized by this act to \'93 make grants to and enter into contracts with public and private entities and individuals to assist in defraying the costs of qualified clinical testing expenses incurred in connection with the development of drugs for rare diseases and conditions.\'94}{ \super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 5(a) (codified as amended 21 U.S.C. 360ee(a) (2003)).}}}{\fs24 The FDA is authorized to create technical and scientific review groups that facilitate its enforcement of the FDCA as amended.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 The Food and Drug Administration Revitalization Act, Pub. L. 101-635, Title III, 104 Stat. 4584 (1990) }{(amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified at 21 U.S.C. \'a7 394 (2003)).}}}{\fs24 \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\tx0\tx959\tx1918\tx2877\tx3836\tx4795\tx5754\tx6712\tx7672\tx8630\nooverflow\faroman\rin0\lin0\itap0 {\fs24 \tab Prior to 1986, the FDA had construed the FDCA to allow the export of approved drugs, but not u napproved new drugs.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\tx0\tx959\tx1918\tx2877\tx3836\tx4795\tx5754\tx6712\tx7672\tx8630\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{\i\kerning0 FDA Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996, FDA, U.S. Department of Health and Human Services}{\kerning0 , (February 1998)}{\i\kerning0 ,}{ \kerning0 }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/opacom/fedregister/frexport.html" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003400000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f006f007000610063006f006d002f00660065006400720065006700690073007400650072002f00660072006500780070006f00720074002e0068007400 6d006c000000e0c9ea79f9bace118c8200aa004ba90b6800000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f006f007000610063006f006d002f00660065006400720065006700690073007400650072002f00660072006500780070006f00720074002e00680074006d006c 000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://www.fda.gov/opacom/fedregister/frexport.html}}}{\kerning0 . }}}{\fs24 This construction disadvantaged the U.S. pharmaceutical industry in the international markets.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\tx0\tx959\tx1918\tx2877\tx3836\tx4795\tx5754\tx6712\tx7672\tx8630\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{ \kerning0 .}}}{\fs24 Congress then passed the Drug Export Amendments Act of 1986, which expands the FDA\rquote s enforcement power with respect to drugs being exported.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ The Drug Export Amendments Act of 1986}{\kerning0 , Pub. L. No. 99-660,}{ 100 Stat. 3743 (1986) (amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7 382 (2003))}}}{\fs24 Such drugs must meet certain criteria in order to be exported,}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\tx0\tx959\tx1918\tx2877\tx3836\tx4795\tx5754\tx6712\tx7672\tx8630\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{ \kerning0 }{\i id}{. at}{\kerning0 \'a7 102, adding \'a7 802(b)(1)}{, }{\kerning0 (repealed 1996), for requirements that must be met before a drug can be approved by the FDA for exportation. }}}{\fs24 and can only be exported to certain countries.}{ \super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\tx0\tx959\tx1918\tx2877\tx3836\tx4795\tx5754\tx6712\tx7672\tx8630\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{ \kerning0 }{\i\kerning0 See}{\kerning0 }{\i\kerning0 id}{\kerning0 . at \'a7 102, adding \'a7 802(b)(4)(B) (codified as amended 21 U.S.C. \'a7 382(b)(1)(B) (2003)), for the criteria used to select which countries get to be on the list of those that can receive drug exports from the U.S., see Section 802 (b)(4)(B).}}}{\fs24 Accordingly, the FDA is mandated to review and approve applications for the export of unapproved drugs, to assure that they comply with this Act.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar \tx0\tx959\tx1918\tx2877\tx3836\tx4795\tx5754\tx6712\tx7672\tx8630\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 102, adding \'a7 802(b)(3) (codified as amended 21 U.S.C. \'a7 382(b)(3) (2003)).}}}{\fs24 There were however a few problems with these amendments. The process of approval of drugs for export was criticized for being too lengthy.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\tx0\tx959\tx1918\tx2877\tx3836\tx4795\tx5754\tx6712\tx7672\tx8630\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{ \i\kerning0 FDA Guidance for Industry on,}{\kerning0 }{\i\kerning0 supra}{\kerning0 note 208.}}}{\fs24 The amendments were criticized for requiring drugs to be approved for export, especially when the impo rting countries had their own health authorities, or had already approved the drug product.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar \tx0\tx959\tx1918\tx2877\tx3836\tx4795\tx5754\tx6712\tx7672\tx8630\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 The export of unapproved drugs was confined to 21 countries, and although the FDA could add more countries to the list, it lacked an \'93administrative mechanism\'94 to accomplish this.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar \tx0\tx959\tx1918\tx2877\tx3836\tx4795\tx5754\tx6712\tx7672\tx8630\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 In addition, the law\rquote s requirement that the unapproved drug being exported must have the same active ingredient as a drug for which approval is being \'93actively pursued,\'94 in the U.S. created some problems. It was not clear \'93the degree t o which the active ingredient had to be the "same" or how "actively" the manufacturer had to be seeking approval.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar \tx0\tx959\tx1918\tx2877\tx3836\tx4795\tx5754\tx6712\tx7672\tx8630\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 Congress later passed the FDA Export Reform and Enhancement Act of 1996 to address these issues. This Act created an administrative mechanism for adding countries onto the list.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar \tx0\tx959\tx1918\tx2877\tx3836\tx4795\tx5754\tx6712\tx7672\tx8630\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{ The FDA Export Reform and Enhancement Act of 1996}{\kerning0 , Pub. L. 104-134, \'a7 2102(a), adding \'a7 802 (b)(1)(C) 110 Stat.. 1321-313 (1996)}{ (amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7 \'a7 381, 382 (2003)).}}}{\fs24 The act replaced the export approval process with a simple notification to the FDA.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar \tx0\tx959\tx1918\tx2877\tx3836\tx4795\tx5754\tx6712\tx7672\tx8630\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2012(a), adding \'a7 802(g) (codified at 21 U.S.C \'a7 382(g) (2003)).}}}{\fs24 The Act frees from regulation the export of drugs for investigational use, or for further processing in anticipation of market a uthorization in any of the listed importing countries.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\tx0\tx959\tx1918\tx2877\tx3836\tx4795\tx5754\tx6712\tx7672\tx8630\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2012(a), adding \'a7 802(c) & (d) (codified at 21 U.S.C \'a7 382(c) & (d) (2003)).}}}{\fs24 The Act also provides for the export of unapproved drugs when the exporter provides the FDA with credible scientific evidence of the drug\rquote s safety and effectiveness, and the importing country request s the approval of the export of that drug to it.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\tx0\tx959\tx1918\tx2877\tx3836\tx4795\tx5754\tx6712\tx7672\tx8630\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2012(a), adding \'a7 802(b)(3) (codified at 21 U.S.C \'a7 382(b)(3) (2003)). }}}{\fs24 The exporters of drugs that treat tropical diseases still need to get FDA approval to export those drugs. They are also required to report any information they receive indicating adverse reactions to such drugs.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\tx0\tx959\tx1918\tx2877\tx3836\tx4795\tx5754\tx6712\tx7672\tx8630\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{ \kerning0 . at \'a7 2012(a), adding \'a7 802(e)(2) (codified at 21 U.S.C \'a7 382(e)(2) (2003)). }}}{\fs24 The FDA was also empowered to prohibit the export of drugs intended to treat tropical diseases if it determines that such export presents an \'93 imminent hazard.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\tx0\tx959\tx1918\tx2877\tx3836\tx4795\tx5754\tx6712\tx7672\tx8630\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2012(a), adding \'a7 802(e)(3)(B) (codified at 21 U.S.C \'a7 382(e)(3)(B) (2003)).}}}{\fs24\cf6 \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\fs24 \tab Congress made some findings that resulted in its passage of the Prescription Drug Marketing Act of 1987.}{\cs17\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ The Prescription Drug Marketing Act of 1987}{\kerning0 , Pub. L. No. 100-293, 102 Stat. 96-99 (1988) }{ (amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7\'a7 353, 381 (2003))}}}{\fs24 Congress found that there were inadequate safeguards \'93 to prevent the introduction and eventual retail sale of substandard, ineffective, or even counterfeit drugs.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{Id. at}{\kerning0 \'a7 2(2) (appears as a note to 21 U.S.C. \'a7 353 (2003)).}}}{\fs24 It also found that there was a wholesale submarket, called the \'93diversion market,\'94 that interfered with FDA regulation of prescription drugs and made it difficult to ascertain the true sources of those drugs.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2(3) (appears as a note to 21 U.S.C. \'a7 353 (2003)).}}}{\fs24 Congress found that there was a massive reimportation of drugs into the U.S. as \'93American goods returned,\'94 that presented a health risk from possible adulteration during foreign handling and shipping.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2(4) (appears as a note to 21 U.S.C. \'a7 353 (2003)).}}}{\fs24 It also found that the drug reimports had an established market that provided a \'93cover for the importation of foreign counterfeit drugs.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2(5) (appears as a note to 21 U.S.C. \'a7 353 (2003)).}}}{\fs24 It was found that the \'93system of providing drug samples to physicians through manufacturers\rquote representatives had been abused for decades and had resulted in the sale to consumers of misbranded, expired, and adulterated pharmaceuticals.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2(6) (appears as a note to 21 U.S.C. \'a7 353 (2003)). }}}{\fs24 These findings prompted Congress to pass t he Prescription Drug Marketing Act of 1987 to \'93assure the integrity of the distribution system for prescription drugs.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2(2) (appears as a note to 21 U.S.C. \'a7 353 (2003)).}}}{\fs24 This Act restricts the importation of prescription drugs that had previously been exported from the U.S.,}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 3 (codified at 21 U.S.C. \'a7 381(d)(1) (2003)).}}}{\fs24 and also restricts the sale and distribution of prescription drug samples.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{ \i\kerning0 See id.}{\kerning0 at \'a7 4 (codified at 21 U.S.C. \'a7 353(c) (2003)), for sales restrictions, and }{\i\kerning0 id}{\kerning0 . at \'a7 5 (codified at 21 U.S.C. \'a7 353(d) (2003)), for distribution restrictions.}}}{\fs24 The FDA is mandated to license wholesale distributors of prescription drugs in interstate commerce and to prescribe regulations establishing the terms and conditions for such licensing.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 6, adding \'a7 503(e)(2)(B) (codified at 21 U.S.C. \'a7 353(e)(2)(B) (2003)).}}}{\fs24 The Act also provides for severe penalties for its violation.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id.}{\kerning0 at \'a7 7 (codified at 21 U.S.C. \'a7 333(b)(1) (2003)), for the penalties provided for violation of various sections of the Act.}}}{\fs24 \par \tab According to Ed Scarbrough, Ph.D., director of the Office of Food Labeling in the FDA's Center for Food Safety and Applied Nutrition, the food industry\rquote s attitude before 1980, was \'93Nutrition won't sell food. It 's price, taste and convenience.\'94 However, in the 1980s Scarbrough noted that nutrition became a big factor in product sales prompting the industry to start making nutrition claims on food.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Paula Kurtzweil, }{\i\kerning0 Good Reading for Good Eating,}{\kerning0 } {\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/fdac/special/foodlabel/goodread.html" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003800000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f0066006400610063002f007300700065006300690061006c002f0066006f006f0064006c006100620065006c002f0067006f006f006400720065006100 64002e00680074006d006c000000e0c9ea79f9bace118c8200aa004ba90b7000000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f0066006400610063002f007300700065006300690061006c002f0066006f006f0064006c006100620065006c002f0067006f006f00640072 006500610064002e00680074006d006c000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://www.fda.gov/fdac/special/foodlabel/goodread.html}}}{\kerning0 . (Paula Kurtzweil is a member of FDA's public affairs staff).}}}{\fs24 Two reports, \'93 the 1988 Surgeon General's Report on Nutrition an d Health, and the 1989 National Research Council's Diet and Health: Implications for Reducing Chronic Disease Risk, concluded that evidence substantiates an association between diet and risk of chronic disease and recommended some dietary changes.\'94 The National Research Council\rquote s report actually recommended amounts of what it considered healthy intakes for certain nutrients.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . }}}{\fs24 However, food labels did not have adequate information to assist consumers to make informed healthy choices.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . }}}{\fs24 The Nutrition Labeling and Education Act of 1990 was passed to prescribe nutrition labeling for foods.}{ \cs17\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ The Nutrition Labeling and Education Act of 1990}{ \kerning0 , Pub. L. No. 101-535, 104 Stat. 2353 (1990) }{(amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7 343 (2003)).}}}{\fs24 The Act prescribes the nutrition information that must be on the label of a food.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{Id. at}{\kerning0 \'a7 2(a) adding \'a7 403 (q)(1) (codified at 21 U.S.C. \'a7 343(q)(1) (2003)).}}}{\fs24 \par \tab The Nutrition Labeling and Education Act of 1990 gives the FDA the authority to requi re through regulations, that any of the required nutrition information be highlighted on the label, if it is deemed necessary to help consumers make informed dietary decisions.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2(a) adding \'a7 403(q)(1)(A) (codified at 21 U.S.C. \'a7 343(q)(1)(A) (2003)).}}}{\fs24 The FDA is also authorized to add or remove a nutrient from the list of required nutrition information.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2(a) adding \'a7 403(q)(2)(A) (codified at 21 U.S.C. \'a7 343(q)(2)(A) (2003)). }}}{\fs24 The FDA is authorized to issue nutrition information guidelines to retailers of raw agricultural commodities and seafood. It is also up to the FDA to designate the 20 varieties (or more if necessary) of vegetables, of fruit an d of raw fish most frequently consumed, that have to observe the nutrition information guidelines.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2(a) adding \'a7 403(q)(4)(B) (codified at 21 U.S.C. \'a7 343(q)(4)(B) (2003)), and \'a7 403(q)(4)(D)(ii) (codified at 21 U.S.C. \'a7 343(q)(4)(D)(ii) (2003)).}}}{\fs24 Further, pursuant to a determination made every two years, if the FDA finds that retailers have not substantially complied with the guidelines, it is autho rized to make such nutrition information requirements mandatory on every retailer selling raw agricultural commodities or raw fish.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2(a) adding \'a7 403(q)(4)(D)(i) (codified at 21 U.S.C. \'a7 343(q)(4)(D)(i) (2003))..}}}{\fs24 The FDA is authorized to regulate claims of relationships between a nutrient whose information is required on the label, and a disease or health-related condition.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 3(a) adding \'a7 403(r)(3) (codified at 21 U.S.C. \'a7 343(r)(3) (2003)), in order to make such claims, the FDA requires that they be \'93based on the totality of publicly available scientific evidence..., that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence.\'94}}}{\fs24 The Act authorizes the FDA to promulgate regulations defining terms used to describe the level of a nutrient in a food, and require that such terms should not be used in a way that is misleading or inconsistent with their definitions.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 3(b)(1)(A) (appears as a note to 21U.S.C. \'a7 343 (2003)), terms used to describe nutrient level in a food include \'93free, low, light or lite, reduced, less and high\'94}}}{\fs24 The FDA\rquote s nutrition information regulations preempt state laws requiring such information,}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 6(a) (codified at 21 U.S.C. \'a7 343-1(a) (2003)).}}}{\fs24 unless they are exempted from such preemption.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id}{\kerning0 . at 6(b) (codified at 21 U.S.C. \'a7 343-1(b) (2003)), for the procedure and conditions necessary to receive exemption from preemption.}}}{\fs24 John Vanderveen, Ph.D., director of FDA's Office of Plant and Dairy Foods and Beverages, observed that this Act made the \'93 United States the first country in the world to have mandatory nutrition labeling and to allow health claims on food labels.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Kurtzweil, }{\i\kerning0 supra}{\kerning0 note 233.}}}{\fs24 \par \tab In 1989, the FDA discovered that a few generic drug manufacturers had engaged in unlawful conduct: \'93falsifying data on drug formulations and illegally giving money to FDA chemists reviewing their drug applications--to gain preferential treatment. \'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Tamar Nordenberg, }{\i\kerning0 Inside FDA: Barring People from the Drug Industry}{\kerning0 , }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/fdac/features/1997/297_debar.html" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003500000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f0066006400610063002f00660065006100740075007200650073002f0031003900390037002f003200390037005f00640065006200610072002e006800 74006d006c000000e0c9ea79f9bace118c8200aa004ba90b6a00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f0066006400610063002f00660065006100740075007200650073002f0031003900390037002f003200390037005f00640065006200610072002e00680074 006d006c000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://www.fda.gov/fdac/features/1997/297_debar.html}}}{\kerning0 . (Tamar Nordenberg is a staff writer for FDA Consumer). }}}{\fs24 This was done to avoid FDA\rquote s regulations.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 In response to this \'93 confidence-shaking discovery,\'94 Congress passed the Generic Drug Enforcement Act of 1992 to ensure the integrity of abbreviated drug applications.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . }{\i\kerning0 See also}{\kerning0 }{The Generic Drug Enforcement Act of 1992}{\kerning0 , Pub. L. No. 102-282, 106 Stat. 149 (1992) }{(amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7\'a7 335a, 335c (2003)).}}}{\fs24 This Act mandates the FDA to debar entities and individuals that have been convicted of certain felonies, from participating in the submission o f any abbreviated drug application, or from assisting persons that have an approved or pending drug application.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 , Pub. L. No. 102-282, }{\i\kerning0 supra}{\kerning0 note 251, at \'a7 2, adding \'a7 306, (codified at 21 U.S.C. \'a7 335a (2003)), for the various felony convictions that can result in debarment, the debarment period, and the procedure for termination of debarment.}}}{\fs24 The FDA is authorized to suspend the distribution of a drug if it finds that the applicant has engaged in the proscribed conduct.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2, adding \'a7 306(g) (codified at 21 U.S.C. \'a7 335a(g) (2003)). }{\i\kerning0 See also}{\kerning0 \'a7 306 (h) (codified at 21 U.S.C. \'a7 335a(h) (2003)), for the procedure for termination of a suspension.}}}{\fs24 The FDA a lso has the authority to withdraw approval of an abbreviated drug application if such approval was obtained fraudulently, or the applicant cannot conform with the application\lquote s requirements.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 4, adding \'a7 308(a) (codified at 21 U.S.C. \'a7 335c(a) (2003)).}}}{\fs24 In addition to these measures, \'93the FDA also tightened its regulatory processes, for better verification of data used to support approval decisions.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Nordenberg, }{\i\kerning0 supra}{\kerning0 note 249.}}}{\fs24 \par \tab The idea of charging applicants fees for reviewing their drug applications first came up in 1971 and then again in 1982, both times being repudiated or failing to garner adequate support.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 John Henkel, }{\i\kerning0 User Fees to Fund Faster Reviews}{\kerning0 ,}{\i\kerning0 }{ \scaps\kerning0 FDA Consumer special report}{\kerning0 (January 1995). \par }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/fdac/special/newdrug/userfees.html" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003600000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f0066006400610063002f007300700065006300690061006c002f006e006500770064007200750067002f00750073006500720066006500650073002e00 680074006d006c000000e0c9ea79f9bace118c8200aa004ba90b6c00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f0066006400610063002f007300700065006300690061006c002f006e006500770064007200750067002f00750073006500720066006500650073002e 00680074006d006c000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://www.fda.gov/fdac/special/newdrug/userfees.html}}}{\kerning0 . }}}{\fs24 In 1992, FDA Commissioner David A. Kessler, M.D., testified before Congress during budget proceedings for the 1993 fiscal year. He impressed upon Congress the significance of user fees to the functioning of the FDA, and urged Cong ress to give the issue due consideration.}{\i\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{ \i\kerning0 Id.}{\kerning0 }}}{\fs24 The FDA and the pharmaceutical industry cooperated to \'93create performance goals and determine what fees would be needed to reach those goals.\'94}{\i\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id.}}}{\fs24 Previous discussions of user fees included many products regulated by the FDA, but the final proposal only comprised of prescription drugs and certain biologics.}{\i\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id.}}}{\fs24 Congress then passed the Prescription Drug User Fee Act of 1992 to \'93make additional funds available for the purpose of augmenting the resources of the FDA that are devoted to the process for review of human drug applications.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{The Prescription Drug User Fee Act of 1992}{\kerning0 , P ub. L. No. 102-571, 106 Stat. 4491 (1992) }{(amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7\'a7 379f, 379g, 379h (2003)). }{\i\kerning0 See also}{\kerning0 }{\i\kerning0 id}{\kerning0 . at \'a7 102 (appearing in a note to 21 U.S.C. \'a7 379g (2003)), for Congress\rquote findings that set forth the purposes of this act.}}}{\fs24 This Act authorizes the FDA to assess and collect fees from human drug applicants.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 103 adding \'a7 736(a) (codified as amended 21 U.S.C. \'a7 379h(a) (2003)). }}}{\fs24\super }{\fs24 The Act also authorizes the FDA to assess and collect fees that must be paid annually by prescription drug establishments and also for every prescription drug product.} {\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 }{\i\kerning0 id}{ \kerning0 . at \'a7 103 adding \'a7 Section 736(a)(2) (codified as amended 21 U.S.C. \'a7 379h(a)(2) (2003)), for more information regarding the prescription drug establishment fee and }{\i\kerning0 id}{\kerning0 . at \'a7 736(a)(3) (codified as amended 21 U.S.C. \'a7 379h(a)(3) (2003)), for more information regarding the prescription drug product fee.}}}{\fs24 It also sets forth a payment schedule and fee schedule for drug application fees, prescription drug establishments fees and prescription drug product fees.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 See }{\i\kerning0 id}{\kerning0 . at \'a7 103 adding \'a7 736(a)(1)(B) (repealed 1997), for the payment schedule and \'a7 736(b)(1) (repealed 1997) (replaced by 21 U.S.C. \'a7 379h(b) (2003)), for the fee schedule.}}}{\fs24 Such fees are mandatory and a ny application is considered incomplete if they are not paid.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{ \kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 103 adding \'a7 736(e) (codified as amended 21 U.S.C. \'a7 379h(e) (2003)).}}}{\fs24 The Act provides that such fees are to be used only for the review of human drug applications.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 103 adding \'a7 736(g) (codified as amended 21 U.S.C. \'a7 379h(g) (2003)).}}}{\fs24 The FDA is also mandated to increase the total fee revenues to reflect an increase in the Consumer Price Index, and to adjust the fees to meet the revenue increase.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 103 adding \'a7 736(c) (codified as amended 21 U.S.C. \'a7 379h(c) (2003)).}}}{\fs24 The FDA is authorized to waive or reduce fees if it finds it necessary to protect the public health or if it would cause an innovation barrier.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 103 adding \'a7 736 (d) (codified as amended 21 U.S.C. \'a7 379h(d) (2003)).}}}{\fs24 \par \tab Even though the FDCA did not allow uses for animal drugs other that the uses they had been approved for (\'93extra-label\'94 uses), the FDA \'93 exercised regulatory discretion regarding extra-label use of animal drugs provided certain criteria were met.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Draft CPG on Use of Medicated Feeds for Minor Species Available}{\i\scaps\kerning0 ,}{\scaps\kerning0 CVM Update, FDA Center for Veterinary Medicine}{\kerning0 (August 26, 1999), }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/cvm/index/updates/minorelu.html" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003300000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f00630076006d002f0069006e006400650078002f0075007000640061007400650073002f006d0069006e006f00720065006c0075002e00680074006d00 6c000000e0c9ea79f9bace118c8200aa004ba90b6600000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f00630076006d002f0069006e006400650078002f0075007000640061007400650073002f006d0069006e006f00720065006c0075002e00680074006d006c000000}} }{\fldrslt {\cs21\ul\cf2\kerning0 http://www.fda.gov/cvm/index/updates/minorelu.html}}}{\kerning0 . }}}{\fs24 The FDA issued a Compliance Policy Guide tha t set forth these criteria, which then largely became part of the Animal Medicinal Drug Use Clarification Act of 1994.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 This Act was passed to \'93 clarify the application of the Act with respect to alternate uses of new animal drugs.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{The Animal Medicinal Drug Use Clarification Act of 1994}{\kerning0 , Pub. L. 103-396,108 Stat. 4153 (1994) }{(amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7 360b (2003)).}}}{\fs24 This Act authorizes the FDA to make regulations establishing conditions for uses of an animal drug other than the use it was approved for.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2(a), adding \'a7 512(a)(4)(A) (codified at 21 U.S.C. \'a7 360b(a)(4)(A) (2003)).}}}{\fs24 The FDA can also establish safe levels for an animal drug residue for such authorized different use, if there\rquote s a public health risk involved.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2(a), adding \'a7 512(a)(4)(B) (codified at 21 U.S.C. \'a7 360b(a)(4)(B) (2003)).}}}{\fs24 If no analytical method has been developed to detect residues above the safe level, then the FDA has the authority to prohibit such use.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 2(a), adding \'a7 512(a)(4)(D) (codified at 21 U.S.C. \'a7 360b(a)(4)(D) (2003)).}}}{\fs24 \par \tab Prior to 1994, the FDA subjected dietary supplements to the same regulatory requirements as foods.}{\super\kerning36 \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{ }{\i\kerning36 Dietary Supplement Health and Education Act of 1994}{\kerning36 , }{\scaps Center for Food Safety and Applied Nutrition, U. S. Food and Dru g Administration}{ (December 1, 1995), }{\field{\*\fldinst { HYPERLINK "http://}{\kerning36 www.cfsan.fda.gov/~dms/dietsupp.html}{" }{{\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000002c00000068007400740070003a002f002f007700770077002e0063006600730061006e002e006600640061002e0067006f0076002f007e0064006d0073002f00640069006500740073007500700070002e00680074006d006c000000e0c9ea79f9bace118c82 00aa004ba90b5800000068007400740070003a002f002f007700770077002e0063006600730061006e002e006600640061002e0067006f0076002f007e0064006d0073002f00640069006500740073007500700070002e00680074006d006c000000}}}{\fldrslt {\cs21\ul\cf2 http://}{\cs21\ul\cf2\kerning36 www.cfsan.fda.gov/~dms/dietsupp.html}}}{\kerning36 . }}}{\fs24 The FDA therefore \'93ensured that they were safe and wholesome, and that their labeling was truthful and not misleading.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning36 Id}{\kerning36 .}}}{\fs24 However, Congress passed the Dietary Supplements Health and Education Act of 1994 to \'93establish standards with respect to dietary supplements.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{The Dietary Supplements Health and Education Act of 1994}{\kerning0 , Pub. L. No. 103-417, 108 Stat. 4325 (1994) }{(amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7\'a7 342(f) & (g), 343-2, 343(r) & (s), 350b (2003)). }}}{\fs24 The act empowers the FDA to report dietary supplement violations to a U.S. attorney for the institution of civil proceedings. In such proceedings, the U.S. has the burden of proof to show that a dietary supplement is adulterated, misbranded or that i ts label is false or misleading.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{ \kerning0 . at \'a7 4 (codified at 21 U.S.C. \'a7 342(f)(1) (2003)).}}}{\fs24 The Act requires dietary supplement manufacturers to notify the FDA about any claim of a relationship between a nutrient and a disease or health condition.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 }{\i\kerning0 id}{\kerning0 . at \'a7 6 (codified at 21 U.S.C. \'a7 343(r)(6) (2003)), for requirements that must be met before such claims may be made.}}}{\fs24 The FDA is given the authority to issue an order \'93prescribing t he conditions under which a new dietary ingredient under its intended conditions of use will reasonably be expected to be safe.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 8, adding \'a7 413(b) (codified at 21 U.S.C. \'a7 350b(b) (2003)).}}}{\fs24 Therefore, other than when a new dietary ingredient is involved, dietary supplements do not need premarket approval.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning36 Overview of Dietary Supplements}{\kerning36 , }{\scaps\kerning0 Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration}{\kerning0 (January 3, 2001),}{\kerning36 }{\field{\*\fldinst {\kerning36 HYPERLINK "http://}{\kerning0 www.cfsan.fda.gov/~dms/ds-oview.html}{\kerning36 " }{\kerning36 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000002c00000068007400740070003a002f002f007700770077002e0063006600730061006e002e006600640061002e0067006f0076002f007e0064006d0073002f00640073002d006f0076006900650077002e00680074006d006c000000e0c9ea79f9bace118c82 00aa004ba90b5800000068007400740070003a002f002f007700770077002e0063006600730061006e002e006600640061002e0067006f0076002f007e0064006d0073002f00640073002d006f0076006900650077002e00680074006d006c000000}}}{\fldrslt {\cs21\ul\cf2\kerning36 http://}{ \cs21\ul\cf2\kerning0 www.cfsan.fda.gov/~dms/ds-oview.html}}}{\kerning0 . }}}{\fs24 The FDA is also authorized to promulgate regulations prescribing good manufacturing practices for the dietary supplements industry.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Public Law 103-417, }{\i\kerning0 supra}{\kerning0 note 276, at \'a7 9 (codified at 21 U.S.C. \'a7 342(g) (2003)),}}}{\fs24 \par \tab Due to a collaboration between the FDA, a coalition of animal industry groups, and manufacturers of animal drugs, Congress passed the Animal Drug Availability Act of 1996 to increase the number of animal drugs on the market.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Jarilyn Dupont, }{\i\kerning0 Animal Drug Availabil ity Act (ADAA) of 1996: Legislative History of ADAA and Import Tolerances}{\kerning0 (January 22, 2002), }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/ohrms/dockets/ac/02/slides/3816s1_01_DUPONT.ppt" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000004300000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f006f00680072006d0073002f0064006f0063006b006500740073002f00610063002f00300032002f0073006c0069006400650073002f00330038003100 3600730031005f00300031005f004400550050004f004e0054002e007000700074000000e0c9ea79f9bace118c8200aa004ba90b8600000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f006f00680072006d0073002f0064006f0063006b006500740073002f00610063002f 00300032002f0073006c0069006400650073002f003300380031003600730031005f00300031005f004400550050004f004e0054002e007000700074000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://www.fda.gov/ohrms/dockets/ac/02/slides/3816s1_01_DUPONT.ppt}}}{\kerning0 . (Jarily D upont is the Senior Legislative Counsel at the FDA). }}}{\fs24 It sets the conditions under which the FDA can decline to approve applications for animal drugs with multiple active ingredients or an animal drug suggeste d for use in combination with another animal drug (\'93combination drugs\'94).}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{The Animal Drug Availability Act of 1996}{\kerning0 , Pub. L. No. 104-250, 110 Stat. 3151 (1996) }{(amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7\'a7 360b, 354 (2003)). }{\i\kerning0 See id}{\kerning0 . at \'a7 2(c) adding \'a7 512(d)(4)(A) (codified at 21 U.S.C. \'a7 360b(d)(4)(A) (2003)).}}}{\fs24 The FDA is authorized to pass regulations specifying the information to be included in a \'93 veterinary feed directive,\'94 supervising the use of a \'93veterinary feed directive drug.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 5(b), adding \'a7 504(a)(1) (codified at 21 U.S.C. \'a7 354(A)(1)(2003)) ( providing that \'93 a drug intended for use in or on animal feed which is limited by an approved application \'85 to use under the professional supervision of a licensed veterinarian is a veterinary feed directive drug.\'94}}}{\fs24 Di stributors of animal feed containing a veterinary feed directive drug are required to notify the FDA of their name and place of business before initiating distribution. They are also required to keep records that are subject to inspection by the FDA.}{ \super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 5, adding \'a7 504(a)(3)(b) (codified at 21 U.S.C. \'a7 354(a(3)(B) (2003)).}}}{\fs24 The Act authorizes the FDA to pass regulations establishing tolerances for new animal drug residues in animals being imported into the U.S.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 4, adding \'a7 512(a)(6) (codified at 21 U.S.C. \'a7 360b(a)(6) (2003)).}}}{\fs24 The Act also requires manufacturers of animal feeds containing new animal drugs to obtain a license from the FDA authorizing such manufacture.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 6(b), amending \'a7 512(m)(1) (codified at 21 U.S.C. \'a7 360b(m)(1) (2003)).}}}{\fs24 A single license for each manufacturer eliminates the previous requirement that each manufacturer obtain multiple \'93Medicated Feed Applications\'94 for each feed mill.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Feed Mill Licensing Now a Reality}{\kerning0 , }{\scaps\kerning0 CVM Update, FDA Center for Veterinary Medicine}{\kerning0 (November 5, 1996), }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/cvm/index/updates/update11596.html" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003600000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f00630076006d002f0069006e006400650078002f0075007000640061007400650073002f00750070006400610074006500310031003500390036002e00 680074006d006c000000e0c9ea79f9bace118c8200aa004ba90b6c00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f00630076006d002f0069006e006400650078002f0075007000640061007400650073002f00750070006400610074006500310031003500390036002e 00680074006d006c000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://www.fda.gov/cvm/index/updates/update11596.html}}}{\kerning0 . }}}{\fs24 This Act \'93reflects the spirit of the White House program to r einvent the government (REGO) by reducing regulatory burdens on the animal health industry without undermining the safety of animal drug products.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 President Signs Animal Drug Availability Act}{\kerning0 , }{\scaps\kerning0 CVM Update, FDA Center for Veterinary Medicine}{\kerning0 (October 18, 1996), }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/cvm/index/updates/adaa.html" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000002f00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f00630076006d002f0069006e006400650078002f0075007000640061007400650073002f0061006400610061002e00680074006d006c000000e0c9ea79 f9bace118c8200aa004ba90b5e00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f00630076006d002f0069006e006400650078002f0075007000640061007400650073002f0061006400610061002e00680074006d006c000000}}}{\fldrslt { \cs21\ul\cf2\kerning0 http://www.fda.gov/cvm/index/updates/adaa.html}}}{\kerning0 . }}}{\fs24 \par \tab Congress passed the Food and Drug Administration Modernization Act (FDAMA) of 1997 to improve FDA\rquote s regulation of food, drugs, devices and cosmetics.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{The Food and Drug Administration Modernization Act of 1997}{\kerning0 , Pub. L. No. 105-115, 111 Stat. 2296 (1997) }{(amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (making amendments to most sections of the FDCA)}}}{\fs24 Through this Act, \'93 Congress affirmed FDA's role as a protector and promoter of the public health of American citizens, endorsed many actions that FDA had already taken to streamline its operations, and added substantial new obligations.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 A Message to FDA Stakeholders, FDA Modernization Act of 1997}{ \kerning0 , }{\scaps\kerning0 FDAMA Communications}{\kerning0 , }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/oc/fdama/comm/message.htm" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000002d00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f006f0063002f006600640061006d0061002f0063006f006d006d002f006d006500730073006100670065002e00680074006d000000e0c9ea79f9bace11 8c8200aa004ba90b5a00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f006f0063002f006600640061006d0061002f0063006f006d006d002f006d006500730073006100670065002e00680074006d000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://www.fda.gov/oc/fdama/comm/message.htm}}}{\kerning0 . }}}{\fs24 This Act renewed the Prescription Drug User Fee Act of 1992 for an additional five years.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Public Law 105-115, }{\i\kerning0 supra}{\kerning0 note 290, at \'a7 101(3) (appears as a note to 21 U.S.C. \'a7379g (2003)).}}}{\fs24 It also exempted from the payment of user fees, orphan drugs and supplemental drug applications that propose a new use in the pediatric population.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 103(a)(2)(C) (codified at 21 U.S.C. \'a7 379h(a)(1)(E) (2003)).}}}{\fs24 \~ The FDA is authorized to request applicants with pending applications for new drugs, to conduct pediatric studies to determine if the new drug can be used in the pediatric population. The FDA can also make such requests to holders of approv ed drug applications \'93for which additional pediatric information may produce health benefits in the pediatric population.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 111, adding \'a7 505A(a) & (c) (codified at 21 U.S.C. \'a7 355a(b) & (c) (2003)). }{\i\kerning0 See also}{ \kerning0 }{\i\kerning0 id}{\kerning0 . at \'a7 505A(d) (codified at 21 U.S.C. \'a7 355a(d) (2003)), for more information on the conduct of pediatric studies.}}}{\fs24 The Best Pharmaceuticals for Children Act of 2002 passed later by Congress, provides more details with respect to the conduct of pediatric studies and pediatric drug approvals.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{The Best Pharmaceuticals for Children Act of 2002}{\kerning0 , Pub. L. No. 107-109, 115 Stat 1408 (2002) }{(amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7\'a7 355a, 379h, 393a and at 42 U.S.C. \'a7 284m (2003)). }{\i\kerning0 See id.}{\kerning0 at \'a7 6 (codified at 21 U.S.C. \'a7 393a), providing for the establishment of an Office of Pediatric Therapeutics within the FDA to handle all FDA activities that involve pediatric issues.}}}{\fs24 The FDA is authorized by FDAMA to designate a new drug as a \'93fast track product\'94 if it is intended to treat a serious or life-threatening condition whose medical needs are unmet, in order for it to receive expedited review.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Public Law 105-115, }{\i\kerning0 supra}{\kerning0 note 290, at \'a7 112, adding \'a7 506(a) (codified at 21 U.S.C. \'a7 356(a) (2003)). . }}}{\fs24 The sponsor for such a fast track product has to conduct post-approval studies and submit copies of all promotional material of the product before and after approval.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 112, adding \'a7 506(b)(2) (codified at 21 U.S.C. \'a7 356(b)(2) (2003)).}}}{\fs24 \par \tab FDAMA requires the FDA to approve a supplemental drug application for a major manufacturing change from the process previously approved, before the drug made with the change can be distributed.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id}{\kerning0 . at \'a7 116, adding \'a7 506A(c) (codified at 21 U.S.C. \'a7 356a(c) (2003)), for the changes that would be considered major and that would thus required FDA approval.}}}{\fs24 The FDA is authorized to issue guidelines on when a drug applicant can submit an abbreviated study report instead of a full report.} {\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 118 (appears at a note to 21 U.S.C. \'a7 355 (2003)). }}}{\fs24 The FDA is also authorized to establish and use scientific advisory panels to provide the FDA with \'93expert scientific advice and recommendations \'85 regarding a clinical investigation of a drug or the approval for marketing of a drug.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 120 (codified at 21 U.S.C. \'a7 355(n) (2003)).}}}{\fs24 FDAMA eliminates the requirement to get FDA certification of drugs containing insulin or antibiotics.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 125 (repeals pre vious sections that required the certification of drugs containing insulin or antibiotics).}}}{\fs24 The FDA is authorized to promulgate regulations setting forth the conditions and manner in which drugs can be compounded by a licensed pharmacist or licensed physician.}{\fs24\super }{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 127, adding \'a7 503A(b)(1)(A) (codified at 21 U.S.C. \'a7 353a(b)(1)(A) (2003)).}}}{\fs24 Such regulations would also include a list of drug substances that have not been approved by the FDA, or which do not have a monograph, that may be used in compounding.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 127, adding \'a7 503A(d)(2) (codified at 21 U.S.C. \'a7 353a(d)(2) (2003)).}}}{\fs24 Licensed pharmacists and licensed physicians can advertise the compounding service, but cannot advertise the compounding of any particular drug, class of drug, or type of drug.}{ \super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 127, adding \'a7 503A(c) (codified at 21 U.S.C. \'a7 353a(c) (2003)).}}}{\fs24 FDAMA requires a manufacturer that is the only manufacturer of a drug that is life-supporting, life-sustaining, or is used in the prevention of a debilit ating disease or condition, to notify the FDA of the discontinuance of such manufacture.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 131, adding \'a7 506C(a) (codified at 21 U.S.C. \'a7 356c(a) (2003)).}}}{\fs24 The FDA is authorized to give review priority to medical devices that are to be used in the treatment or diagnosis of a life-threatening or debilitating diseases.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id}{\kerning0 . at \'a7 202 (codified at 21 U.S.C. \'a7 360e(d)(5) (2003)), these devices have to represent breakthrough technologies, have no approved alternatives, or have significant advantages over existing approved alternatives.}}}{\fs24 \par \tab FDAMA authorizes the FDA to recognize and withdraw recognition of performance standards for medical devices that have been established by a nationally or internationally recognized standard development organization.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 204 (codified at 21 U.S.C. \'a7 360d(c) (2003)).}}}{\fs24 The FDA is also authorized to accredit persons to review reports and make recommendations to the FDA regarding the initial classification of medical devices.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id.}{\kerning0 at \'a7 210, adding \'a7 523(a)(3) (codified at 21 U.S.C. \'a7 360m(a)(3) (2003)), for activities the accredited persons may not perform, and Section 523(b) for the procedure, qualifications and withdrawal of accreditation.}}}{\fs24 The FDA is authorized to pass regulations setting forth the conditions under which a food additive that is a food contact may be safely used.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 309(a), adding \'a7 409(a)(3) (codified at 21 U.S.C. \'a7 348(a)(3) (2003)).}}}{\fs24 A \'93 food contact substance\'94 is \'93any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in such food.\'94}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 309(b)(2), adding \'a7 409(h)(6) (codified at 21 U.S.C. \'a7 348(h)(6) (2003)).}}}{\fs24 FDAMA req uires manufacturers of food contact substances to provide only a simple notification to the FDA identifying the substance, its intended use and a determination that such use is safe, before introduction into interstate commerce. If the FDA determines tha t a food contact substance has not been shown to be safe, it can object to the notification, \'93which shall constitute final agency action subject to judicial review.\'94}{\fs24\super }{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 309(b)(2), adding \'a7 409(h)(2) (codified at 21 U.S.C. \'a7 348(h)(2) (2003)).}}}{\fs24 FDAMA requires the manufacturer of a drug or device to have submitted a supplemental app lication for a new use before circulating information regarding the safety and effectiveness of such new use to certain individuals and entities.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 401(a), adding \'a7 551(a) and \'a7 554(a) (codified at 21 U.S.C. \'a7 360aaa(a) and \'a7 360aaa-3(a) r espectively (2003)).}}}{\fs24 The FDA has to review a copy of the information before it is circulated and can require further objective information regarding the safety or effectiveness of such new use.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 401(a), adding \'a7 551(c) (codified at 21 U.S.C. \'a7 360aaa(c) (2003)).}}}{\fs24 The FDA is also authorized to order a cessation of circulation of the information if it determines that the information fails to conform to the requirements established by FDAMA.}{\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 401(a), adding \'a7 555(b)(1) (codified at 21 U.S.C. \'a7 360aaa-4(b)(1) (2003)).}}}{\fs24 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\fs24 FDAMA e mpowers the FDA to authorize the use of unapproved investigational drugs or devices for the treatment of a serious disease or condition in emergency situations, or pursuant to an \'93expanded access protocol.\'94}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i\kerning0 Id}{\kerning0 . at \'a7 402, adding \'a7 561(a) and (c) (codified at 21 U.S.C. \'a7 360bbb(a) (2003)).}}}{\fs24 FDAMA mandates the FDA to establish and publish regulations setting forth standards for the timely review of supplemental applications submitted for approved articles under the FDCA.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 403(a) (appears as a note to 21 U.S.C. \'a7 371 (2003)).}}}{\fs24 The FDA is also mandated to pass regulations establishing a procedure for the resolution of any scientific controversies between the FDA and an applicant requesting any FDA action.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 404, adding \'a7 562 (codified at 21 U.S.C. \'a7 360bbb-1 (2003)).}}}{\fs24 The FDA is also authorized to develop guidelines, after public participation, \'93setting forth initial interpretations of a statute or regulation, changes in interpretation or policy that are o f more than a minor nature, complex scientific issues, or highly controversial issues.\'94}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 405, adding \'a7 701(h)(1)(C) (codified at 21 U.S.C. \'a7 371(h)(1)(C) (2003)).}}}{\fs24 The FDA is mandated to establish an information system to monitor the status and progress of each application submitted to it requesting its action.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 407(a), adding \'a7 741 (codified at 21 U.S.C. \'a7 379k (2003)).}}}{\fs24 The FDA is auth orized to promulgate regulations restricting the sale of mercury intended to be used as a drug or dietary supplement if it determines that such use poses a threat to human health.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 413(c)(2) (appearing as note to 21 U.S.C. \'a7 393 (2003)).}}}{\fs24 The FDA is authorized to contract for expert review to obtain recommendations with respect to applications submitted to the FDA.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 415, adding \'a7 907(a)(1) (codified at 21 U.S.C. \'a7 397(a)(1) (2003)).}}}{\fs24 FDAMA also requires foreign establishments \'93engaged in the manufacture, preparation, propagation, compounding or processing of a drug or device that is imported into the U.S.,\'94 to register with the FDA.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 417, amending \'a7 510(i) (codified at 21 U.S.C. \'a7 360(i) (2003)).}}}{\fs24 \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\fs24 \tab Congress passed the Medicine Equity and Drug Safety Act of 2000 in order to make accessible to Americans prescription drugs available in other countries at significantly lower prices than in the U.S.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{The Medicine Equity and Drug Safety Act of 2000}{\kerning0 , Pub. L. 106-387, 114 Stat 1549A-35 (2000) }{(amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified at 21 U.S.C. \'a7 384 (2003)). }}}{\fs24 This Act authorizes the FDA to promulgate regula tions allowing pharmacists and wholesalers to import prescription drugs into the U.S.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 745(c), adding \'a7 804(a) (codified at 21 U.S.C. \'a7 384(a) (2003)). }}}{\fs24 Such imported prescription drugs have to meet the safety and effectiveness requirements of the FDCA.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 745(c), adding \'a7 804(b)(1) (codified at 21 U.S.C. \'a7 384(b)(1) (2003)). }}}{\fs24 The importers are required to keep records on such importation and to provide the FDA certain information.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 745(c), adding \'a7 804(c) (codified at 21 U.S.C. \'a7 384(c) (2003)). }{\i\kerning0 See id.}{\kerning0 at \'a7 804(d) (codified at 21 U.S.C. \'a7 384(d) (2003)), for the information that importers need to provide the FDA.}}}{\fs24 The importers are also required to test the imported shipment for authentication and degradation and to assure that the product\rquote s labeling conforms to FDCA requirements.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 745(c), adding \'a7 804(e) (codified at 21 U.S.C. \'a7 384(e) (2003)). }}}{\fs24 This act also provides that the prescription drugs can only be imported from countries that are listed or designated by the FDA.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 745(c), adding \'a7 804(f) (codified at 21 U.S.C. \'a7 384(f) (2003)). }}}{\fs24 The FDA is authorized to suspend the importation of a specific prescription drug if it determines that such importation is in violation of a requirement of this Act, or that the imported product is counterfeit.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 745(c), adding \'a7 804(g) (codified at 21 U.S.C. \'a7 384(g) (2003)). }}}{\fs24 The Act however can only become effective if the Secretary of the HHS determines that it will \'93pose no additional risk to the public\rquote s health and safety and [will] result in a significant reduction in the cost of covered products to the American consumer.\'94}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 745(c), adding \'a7 804(l) (codified at 21 U.S.C. \'a7 384(l) (2003)). }}}{\fs24 HHS secretary Tommy G. Thompson found that these conditions could not be assured and declined to implement this Act upon determining that it would \'93sacrifice public safety by opening up the closed distribution system in the United States.\'94}{ \fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Michelle Meadows, }{\i\kerning36 Imported Drugs Raise Safety Concerns}{\kerning36 , }{\scaps\kerning36 FDA Consumer magazine}{\kerning36 (}{\kerning0 September-October 2002), }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/fdac/features/2002/502_import.html" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000003600000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f0066006400610063002f00660065006100740075007200650073002f0032003000300032002f003500300032005f0069006d0070006f00720074002e00 680074006d006c000000e0c9ea79f9bace118c8200aa004ba90b6c00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f0066006400610063002f00660065006100740075007200650073002f0032003000300032002f003500300032005f0069006d0070006f00720074002e 00680074006d006c000000}}}{\fldrslt {\cs21\ul\cf2\kerning0 http://www.fda.gov/fdac/features/2002/502_import.html}}}{\kerning0 . }}}{\fs24 \par \tab Congress passed the Prescription Drug Import Fairness Act of 2000 to clarify the FDA\rquote s obligations with respect to importation of approved drugs by patients and their families.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 The }{Prescription Drug Import Fairness Act of 2000}{\kerning0 , Pub. L. No. 106-387, 114 Stat 1549A-40 (2000) }{(amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified at 21 U.S.C. \'a7 381(g) (2003)). }}}{\fs24 If the FDA decides that a certain drug import that an individual is seeking violates the FDCA, this Act requires the FDA to provide the individual with a detailed notice of the reasons for the decision.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 746(b)(3) (appears in note to 21 U.S.C. \'a7 381 (2003)). }{\i\kerning0 See}{\kerning0 }{\i\kerning0 id}{\kerning0 . at \'a7 746(c) (codified at 21 U.S.C. \'a7 381(g) (2003)), for the requirements that such a notice must meet.}}}{\fs24 \par \tab Following the terrorist attacks of September 11, 2001, Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. This Act was passed to \'93 improve the ability of the U.S. to prevent, prepare for, and to respond to bioterrorism.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{The Public Health Security and Bioterrorism Preparedness and Response Act of 2002}{\kerning0 , Pub. L. No. 107-188, Title III, 116 Stat. 662 (2002) }{ (amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7\'a7 381, 334(h), 335a(b), 350d, 350c, 374, 360, 342(h) (2003)). }}}{\fs24 Title III of this Act specifically deals with protecting the safety and sec urity of the food and drug supply. In order to protect against bioterrorist threats to the food supply, the FDA is mandated to give high priority to increasing the number of inspections of food being imported, at the ports of entry into the U.S.}{ \fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 302(a), adding \'a7 801(h)(1) (codified at 21 U.S.C. \'a7 381(h)(1) (2003)).}}}{\fs24 The FDA is also mandated to develop an information management system that deals with imported foods, to enable the FDA to allocate sufficient funds for the purposes of detecting purposeful adulteration of the food.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 302(b) adding \'a7 801(h)(2) (codified at 21 U.S.C. \'a7 381(h)(2) (2003)).}}}{\fs24 The FDA is also charged with developing \'93rapid detection\'94 tests and sampling methodologies for the detection of intentional adulteration of food and to conduct an assessment of the threat of intentional adulteration of food.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 302(d) adding \'a7 801(i) (codified at 21 U.S.C. \'a7 381(i) (2003)), and }{\i\kerning0 id}{\kerning0 . at \'a7 801(e).}}}{\fs24 This Act also adds onto the list of persons subject to debarment, those that have been \'93 convicted of a felony for conduct relating to the importation into the U.S. of any food.\'94}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 304(a)(2)(C), adding \'a7 306(b)(3) (codified at 21 U.S.C. \'a7 335a(b)(3) (2003)).}}}{\fs24 The Act also requires domestic and foreign facilities that manufacture, process, pack or hold food for consumption in the U.S., to register with the FDA.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 305, adding \'a7 415(a) (codified at 21 U.S.C. \'a7 350d(a) (2003)).}}}{\fs24 Food importers are also required to notify the FDA of any imported food shipments to facilitate inspection of such food at the port of entry.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 307(a), adding \'a7 801(m)(1) (codified at 21 U.S.C. \'a7 381(m)(1) (2003)).}}}{\fs24 The Act empowers the FDA to require that food that has been barred from entry, bear the sign \'93UNITED STATES: REFUSED ENTRY,\'94 until it is brought into compliance with the FDCA.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 308(a), adding \'a7 801(n) (codified at 21 U.S.C. \'a7 381(n) (2003)).}}}{\fs24 The Act also prohibits \'93port shopping.\'94}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 309, adding \'a7 402(h) (codified at 21 U.S.C. \'a7 342(h) (2003)). }}}{\fs24 This Act requires annual registration with the FDA of foreign manufacturers of drugs and devices that are imported into the U.S.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 321(a), amending \'a7 510(i)(1) (codified at 21 U.S.C. \'a7 360(i)(1) (2003)).}}}{\fs24 The Act requ ires persons importing components of drugs and devices to be incorporated in a product intended for export, to submit to the FDA certain detailed information, to keep records, and make reports that the FDA may require.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 322(a), amending \'a7 801(d) (3) (codified at 21 U.S.C. \'a7 381(d)(3) (2003)).}}}{\fs24 \par \tab Congress recognized that the resources the FDA allocated to reviewing medical device applications had been decreasing in recent years, and consequently, review was taking longer periods of time.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\keepn\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning36 The Medical Device User Fee and Modernization Act of 2002: FAQs}{ \kerning36 (}{\kerning0 November 7, 2002), }{\field{\*\fldinst {\kerning0 HYPERLINK "http://www.fda.gov/cber/mdufma/mdufma02faq.htm" }{\kerning0 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b02000000170000002f00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f0063006200650072002f006d006400750066006d0061002f006d006400750066006d006100300032006600610071002e00680074006d000000e0c9ea79 f9bace118c8200aa004ba90b5e00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f0063006200650072002f006d006400750066006d0061002f006d006400750066006d006100300032006600610071002e00680074006d000000}}}{\fldrslt { \cs21\ul\cf2\kerning0 http://www.fda.gov/cber/mdufma/mdufma02faq.htm}}}{\kerning0 . }}}{\fs24 Congress then passed the Medical Device User Fee and Modernization Act of 2002 to make \'93additi onal funds available for the purpose of augmenting the resources of the FDA that are devoted to the process for the review of devices and the assurance of device safety and effectiveness so that statutorily mandated deadlines may be met.\'94}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{The Medical Device User Fee and Modernization Act of 2002}{ \kerning0 , Pub. L. No. 107-250, \'a7 101(2), 116 Stat. 1588 (2002) }{(amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified principally at 21 U.S.C. \'a7\'a7 379i, 379j, 374(g), 360m(d), 335a(m) 353(g)(4), 352(f), 352(u) (2003)). }}}{ \fs24 The FDA was authorized to assess user fees against premarket applications, premarket reports, supplement applications and premarket notifications.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 102(a), adding \'a7 738(a)(1)(A) (codified at 21 U.S.C. \'a7 379j(a)(1)(A) (2003)). }{\i\kerning0 See also}{\kerning0 }{\i\kerning0 id}{\kerning0 . at \'a7 738(a)(1)(B) (codified at 21 U.S.C. \'a7 379j(a)(1)(B) (2003)), for the exceptions to the user fee requirements of this Act.}}}{\fs24 The Act sets forth the fee revenue to be collected each year from 2003 to 2007, which then determines the amount of fees t o be paid by persons making medical device-related submissions to the FDA.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 102(a), adding \'a7 738(b) (codified at 21 U.S.C. \'a7 379j(b) (2003)). }}}{\fs24 Applications submitted without the required fees are considered incomplete.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 102(a), adding \'a7 738(f) (codified at 21 U.S.C. \'a7 379j(f) (2003)). }}}{\fs24 The FDA is authorized to adjust these revenues for inflation, workload and shortfalls from previous years.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 102(a), adding \'a7 738(c) (codified at 21 U.S.C. \'a7 379j(c) (2003)). }}}{\fs24 The Act mandates that the fees assessed are to be sued only for the review of medical device applications.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 102(a), adding \'a7 738(h)(1) (codified at 21 U.S.C. \'a7 379j(h)(1) (2003)). }}}{\fs24 A condition of assessing user fees, is that the FDA is expected to meat all its \'93performance goals.\'94}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 102(a), adding \'a7 738(g) (codified at 21 U.S.C. \'a7 379j(g) (2003)). }}}{\fs24 The Act also makes additional appropriations to the FDA for the purpose of conducting postmarket surveillance of medical devices.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 104(a).}}}{\fs24 This Act authorizes the FDA to accredit persons to inspect facilities that manufacture, prepare, propagate, compound or process class II or class III devices.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 }{\i\kerning0 id}{\kerning0 . at \'a7 201, adding \'a7 704(g)(3) (codified at 21 U.S.C. \'a7 374(g)(3) (2003)), for the requirements accredited persons need to meet, the procedure of accreditation and withdrawal of accreditation.}}}{\fs24 The Act also gives the FDA the authority to debar an accredited person that is convicted of a felony for conduct relating to an inspection.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 }{\i\kerning0 Id}{\kerning0 . at \'a7 203, adding \'a7 306(m) (codified at 21 U.S.C. \'a7 335a(m) (2003)), for information on the debarment period and termination of debarment.}}}{\fs24 \par \tab The FDA\rquote s enforcement powers have been expanded dramatically by Congress over time, through the passage of the FDCA and its amendments. \par \tab \par }{\b\fs24\ul THE COURTS\rquote TREATMENT OF FDA ENFORCEMENT OBLIGATIONS \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\fs24 In a 1986 case, the Supreme Court concluded that the FDCA does not create or imply a private right of action for individuals injured as a result of violations of the Act.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Merrell Dow Pharmaceuticals, Inc. v. Thompson, 478 U.S. 804, 815 (1986).}}}{\fs24 The F DA is therefore the sole authority that can enforce the provisions of the FDCA and ensure compliance with the FDCA. Injured individuals can still sue a violator for negligence in state courts. A court could interpret a violation of the FDCA as an indica tion of a manufacturer\rquote s negligence in such a suit. }{\fs24 The Fourth Circuit held in a diversity suit by a plaintiff against the manufacturer of a misbranded medical device, whose misbranding was the proximate cause of the plaintiff\rquote s injury, that the violation of the FDCA is negligence per se in Virginia.}{\cs17\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \cs17\super \chftn }{ Orthopedic Equipment Co. v. Eutsler, 276 F.2d 455, 461 (4}{\super th}{ cir. 1960)}}}{\fs24 The court noted that while the FDCA does not provide a private right of action for injured consumers, it \'93 imposes an absolute duty on manufacturers not to misbrand their products and a breach of this duty may give rise to civil liability.\'94}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i Id}{. at 460.}}}{\fs24 \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\b\fs24\ul \par Courts\rquote Treatment of FDA\rquote s Inspection and Seizure Powers}{\b\fs24 \tab }{\b\fs24\ul \par }{\fs24 \tab The Supreme Court in }{\i\fs24 United States v. Cardiff}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 344 U.S. 174, 176-177 (1952) - in this case, the Supreme court affirmed the reversal of the respondent who had been convicted of violating Section 301(f) of the FDCA (codified as 21 U.S.C. \'a7 331(f)), which prohibits the refusal to permit entry and inspection pursuant to authorized by Section 704 (codified as 21 U.S.C. \'a7 374). }}}{\fs24 found that on its face, the FDCA only prohibited the refusal to permit entry and inspection if permission had previously been granted. The Court pointed out that Section 704 of the FDCA conditioned entry and inspection on \'93 making request and obtaining permission,\'94 and that on its face, the FDCA apparently gave factory managers the right to withhold permission to enter and inspect.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . }}}{\fs24 This construction of the FDCA would obviously have crippled the FDA\rquote s efforts at inspecting facilities and protecting the public health. Congress thus amended Section 704 of the FDCA eliminating the provision requiring the FDA to obtain per mission before entering at reasonable times to inspect facilities in which food, drugs, devices, or cosmetics are manufactured, processed, packed or held for introduction into interstate commerce, or held after such introduction.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 Act of Aug. 7, 1953, Pub. L. No. 83-217, amending \'a7 704(a), 67 Stat. 476 }{(amending }{\kerning0 Pub. L. No. 75-717, 52 Stat 1040 (1938)) (codified at 21 U.S.C. \'a7\'a7 374 (a)(1) (2003)).}}}{\fs24 The Amended section 704 only requires the FDA to give a written notice to the owner or operator of a facility before entering to inspect, but does not require the FDA to obtain consent.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id.}}}{\fs24 This section \'93 simply and unequivocally authorizes FDA to enter and inspect certain specified premises at reasonable times.\'94}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Daley v. Weinberger, 400 F. Supp. 1288, 1291, n.3 (E.D.N.Y. 1976), }{\i\kerning0 aff\rquote d,}{\kerning0 536 F2d 519 (2nd Cir. 1976), }{\i\kerning0 cert. denied,}{\kerning0 430 U.S. 930 (1977).}}}{\fs24 \par \tab Although Administrative searches are subject to the safeguards of the Fourth Amendment, and thus require a warrant issued upon a showing of probable cause,}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 See v. Seattle, 387 U.S. 541, 546 (1967), requires that an administrative search of commercial property be supported by a search warrant. It however provides that the standard of probable cause required to obt ain a warrant for an administrative search is lower than that required for the issuance of a warrant in criminal cases.}}}{\fs24 there is an exception eliminating the warrant requirement in administrative searches of \'93closely regulated\'94 industries. }{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 New York v. Burger, 482 U.S. 691, 719 n.2 (1987) cites as examples of \'93closely regulated\'94 industries, the liquor industry, firearm and ammunition sales, the coal mine industry and then finds the vehicle dismantlers industry to be closely regulated as well.}}}{\fs24 This exception is referred to as the }{\i\fs24 Colonnade-Biswell}{\fs24 exception.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 U.S. v. Argent Chem. Lab., 93 F.3d 572, 575-576 (9th Cir. 1996)}}}{\fs24 Courts have held that warrantless searches under Section 374 of the FDCA are valid as they fall within the }{\i\fs24 Colonnade-Biswell}{\fs24 exception.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 U.S. v. New England Grocers Supply Co., 488 F. Supp. 230, 238 (D. Mass. 1980) The court pointed out that there was a long history of pervasive federal regulation of the food and drug industry and thus that warrantless inspections pursuant to \'a7 374 are fully consistent with the Fourth Amendment. }{\i\kerning0 See also}{\kerning0 }{\i\kerning0 Argent Chem. Lab}{\kerning0 ., 93 F.3d at 575-576 (concluding that the drug industry, including the animal drug segment, was closely regulated by the government, and thus subject of warrantless search and seizure by the FDA). }{\i\kerning0 See also}{\kerning0 , U.S. v. Fogari, 1988 U.S. Dist. LEXIS 10166 (D. N.J. 1988) (concluding t the pharmaceutical industry is a closely regulated field and thus subject to warrantless inspection by the FDA).}}}{\fs24 Courts have also consistently held that FDA officials conducting inspections pursuant to Section 374 do not need to give }{\i\fs24 Miranda}{\fs24 warnings, as such inspections are non-custodial.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 New England Grocers Supply Co.,}{\kerning0 442 F. Supp. at, 48 (D. Mass. 1977), }{\i\kerning0 citing}{\kerning0 , U.S. v. Thriftimart, Inc., 429 F.2d 1006 (9th Cir. 1970) }{\i\kerning0 cert. denied, }{\kerning0 400 U.S. 926 (1970) }{\i\kerning0 reh. denied,, }{\kerning0 400 U.S. 1002 (1971).}}}{ \fs24 The Ninth Circuit has held that the FDA is not required to give advance notice of an inspection, as \'93the necessity and constitutionality of a surprise search was expressly upheld\'94 by the Supreme Court.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Thriftimart, Inc., }{\kerning0 429 F.2d at 1010, }{\i\kerning0 citing}{\kerning0 , }{\i\kerning0 See v. Seatle}{\kerning0 , 387 U.S. at 545 n.6 (1967).}}}{\fs24 Further, the FDA is not required to give a separate notice of inspection for each day of a multiple day inspection,}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 U.S. v. Durbin, 373 F. Supp 1136, 1137 (E.D. Okla. 1974). }}}{\fs24 nor even specify in the notice the reason underlying the inspection or what it expects to find.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 }{\i\kerning0 Weinberger}{\ul\kerning0 }{\kerning0 400 F. Supp at 1291 n.3. }}}{\fs24 The FDA is also not required to inform the party being inspected whether it intends to proceed criminally or civilly against such party.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Thriftimart, Inc.,}{\kerning0 429 F.2d at 1010, }{\i\kerning0 citing}{ \kerning0 , U.S. v. Kordel, 397 U.S. 1 (1970).}}}{\fs24 \tab In order to facilitate FDA\rquote s inspection obligation, Section 373 provides a method by which the FDA can obtain interstate shipment information from carriers. The fourth circuit gave a broad interpretation to Section 373, finding that it does not exclude permissive investigation of interstate shipment records from manufacturing facilities.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 U.S. v. 75 Cases, etc., 146 F.2d 124, 127 (4th Cir. 1944), }{\i\kerning0 cert. denied,,}{\kerning0 325 U.S. 856 (1945).}}}{\fs24 The court also affirmed the FDA\rquote s authority to take samples during inspections by noting that \'93Section 372(b) of the Act clearly contemplates the taking of samples.\'94}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\ul\kerning0 .}{\kerning0 at 128.}}}{\fs24 \par \tab The Supreme court concluded that Section 304(a), which \'93authorizes multiple libels for condemnation of misbranded articles upon the FDA\rquote s finding of probable cause that a misbranded article is dangerous to health, or that its labeling is fraudulent, or would be in material respect misleading to the injury and damage of a purchaser or consumer,\'94 does not violate due process.}{ \fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Ewing v. Mytinger & Casselber ry, Inc., 339 U.S. 594, 598 (1950), }{\i\kerning0 reh. denied, }{\kerning0 340 U.S. 857 (1950).}}}{\fs24 The Court found that the owner of the seized articles has an opportunity to have a fully hearing in court when the FDA files the libel and that this hearing satisfies the requirements of due process.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at 598. }}}{\fs24 \par \par }{\b\fs24\ul Courts\rquote Treatment of FDA\rquote s Power to Seek Injunctions \par }{\fs24 \tab The First Circuit has held that there is no right to a jury trial in an action for an injunction under 21 U.S.C. \'a7 332(a), as the action is purely equitable in nature.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 U.S. v. Articles of Drug Consisting of Following: 5,906 Boxes, etc., 745 F.2d 105, 112 (1st Cir. 1984), }{\i\kerning0 cert. denied}{\kerning0 , 470 U.S. 1004 (1985). }{\i\kerning0 See also}{\kerning0 U.S v. Ellis Re search Laboratories, Inc., 300 F.2d 550, 554 (7th Cir. 1962) }{\i\kerning0 cert. denied, }{\kerning0 370 U.S. 918 (1962) (stating that the Seventh Amendment which preserves the right of trial by jury to \'93suits at common law,\'94 does not apply to an action for injunctive relief, which has historically been equitable in nature, with the factual issues raised triable by the court). }{\i\kerning0 See also}{\kerning0 U.S. v. Louisiana, 339 U.S. 699, 706 (1950) (noting that the Seventh Amendment only applies to actions at law and not equity actions for injuctions).}}}{\fs24 The Ninth Circuit stated that the standards for granting a preliminary injunction are different where the injunction is being sought pursuant to a statute, such as the FDCA, rather than pursuant to claims of two private litigants.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 In U.S. v. Odessa Union Warehouse Co-op, 833 F.2d 172, 174-175 (9th Cir. 1987), the court announced the factors traditionally considered in determining whether to grant a preliminary injunction in a suit between two private litigants in the 9th circuit : (1) the likelihood of plaintiff's success on the merits; (2) the possibility of plaintiff's suffering irreparable injury if relief is not granted; (3) the extent to which the balance of hardships favors the respective parties; and (4) in certain cases, whether the public interest will be advanced by the provision of preliminary relief.}}}{\fs24 That cour t declared that the FDA was not required to show irreparable injury in seeking a statutory injunction, and that such irreparable injury should be presumed.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 }{\i\kerning0 id}{\ul\kerning0 .}{\kerning0 at 175, }{ \i\kerning0 citing}{\kerning0 , Navel Orange Admin. Comm. v. Exeter Orange Co., 722 F.2d 449, 453 (9th Cir. 1983), and, SEC v. Mgmt. Dynamics, Inc., 515 F.2d 801, 808 (2d Cir. 1975). }}}{\fs24 After noting that the required degree of a showing of probable success on the merits decreases as the likelihood of irreparable harm increases, the Ninth Circuit announced that the FDA would only need to show some chance of probable success on the merits, since the irreparable injury requirement is presumed for statutory injunctions.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 }{\i\kerning0 Odessa Union}{ \kerning0 , 833 F.2d at 176.}}}{\fs24 The court also announced that in balancing the hardships that would result from the issuance of a preliminary injunction the court has to balance the hardships that face the party to be enjoined, against the public \rquote s interest in consuming unadulterated food.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{ \kerning0 }{\i\kerning0 Id.}}}{\fs24 It then cited }{\i\fs24 Smith v. California}{\fs24 ,}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 361 U.S. 147, 152 (1959) }}}{\fs24 which stated that \'93the usual rationale behind food and drug legislation is that \lquote the public interest in the purity of its food is so great as to warrant the imposition of the highest standard of care on distributors.\rquote "}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See, Odessa Union}{\kerning0 , 833 F.2d at 176.}}}{\fs24 In discuss ing the required showing of the likelihood of recurring violations, the court noted that the cessation of violations does not itself foreclose issuance of an injunction.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id.,}{\kerning0 }{\i\kerning0 citing}{\kerning0 , City of Mesquite v. Aladdin\rquote s Castle, Inc., 455 U.S. 283, 289 (1982).}}}{\fs24 It also cautioned courts to \'93beware of attempts to forestall injunctions through rem edial efforts and promises of reform that seem timed to anticipate legal action, especially when there is the likelihood of recurrence.\'94}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See, Odessa Union}{\kerning0 , 833 F.2d at 176, citing, U.S. v. Oregon State Medical Society, 343 U.S. 326, 333 (1952).}}}{\fs24 District courts have also held that the FDA does not need to show that the food in question was injurious to health in order to get an injunction against the shipment of such food.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 , U.S. v. Lazere, 56 F. Supp. 730, 732 (D.C. Iowa 1944). }{ \i\kerning0 See also,}{\kerning0 U.S. v. Medwick Lab. Inc., 416 F. Supp. 832, 833 (N.D. Ill. E. Div. 1976) (noting that proof of irreparable injury or proof that the drugs are unsafe is unnecessary for injunctive relief under the FDCA).}}}{\fs24 \par \tab The Sixth Circuit held that a district court sitting in equity pursuant to 21 U.S.C. \'a7 332(a),}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 This section grants the district court jurisdiction to enjoin violations of the FDCA.}}}{\fs24 had the authority to order restitution in addition to issuing an injunction.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 , U.S. v. Universal Mgmt. Servs., 191 F.3d 750, 762 (6th Cir. 1999).}}}{\fs24 This court noted that the Supreme Court in }{\i\fs24 Porter v. Warner Holding Co.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 328 U.S. 395, 398 and 402 (1946). }}}{\fs24 established that, "unless otherwise provided by statute, all the inherent equitable powers of the District Court are available for the proper and complete exercise of that jurisdiction ... and that restitution is within the recognized power and within the highest tradition of a court of equity."}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Universal Mgmt. Servs.,}{\kerning0 191 F.3d at 761. }}}{\fs24 The Court then went on to hold that nothing in the FDCA precludes a district court from ordering restitution and that restitution is therefore a remedy available to a district court in appropriate cases under 21 U.S.C. \'a7 332(a).}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\ul\kerning0 .}{\kerning0 at 762.}}}{\fs24 \par \par }\pard \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\b\fs24\ul Courts\rquote Treatment of FDA\rquote s Criminal and Civil Proceedings and the Pre-Prosecution Hearing Requirement}{\fs24 \par \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\fs24 Courts have observed that if the FDCA is literally enforced, all processed food would be excluded from interstate commerce.}{\cs17\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ In U.S. v. 484 Bags, More or Less, 423 F.2d 839, 841 (5}{\super th}{ Circuit 1970), the court notes that Section 343(a)(3) considers any food adulterated if it consists in whole or in part of any filthy, putrid or decomposed substances, and then observes that \'93 a scientist with a microscope could find filthy, putrid, and decomposed substances in almost any canned food we eat."}}}{\fs24 They have accordingly recognized that the FDA has the discretion to develop \'93administrative working tolerances\'94 to aid in deciding}{ }{\fs24 which}{ }{\fs24 violations to proceed against, and which to consider }{\cs15\i\fs24 de minimis}{.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i Id}{\ul .}{ at 841, }{\i citing}{, U.S. v. 133 Cans of Tomato Paste, 22 F. Supp. 515, 516 (E.D. Pa. 1938) (accepting an FDA tolerance as a standard for determining whether a food in adulterated within the meaning of the FDCA).}}}{ }{\fs24 The Fifth Circuit has held that a court can apply a stricter standard than the FDA in finding a food adulterated, even though it is within the FDA\rquote s tolerances. It however noted that due to the FDCA\rquote s purpose of protecting the public health, a court cannot apply a standard below the FDA\rquote s tolerances.}{\cs17\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i 484 Bags, More or Less}{, 423 F.2d at, 842.}}}{\fs24 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 { }{\fs24 Section 306 of the FDCA authorizes the FDA to issue warnings for minor violations rather than report them for prosecution, or for the institution of libel or injunction proceedings.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ This section is codified in 21 U.S.C. \'a7 336.}}}{\fs24 A district court has inte rpreted the FDCA as vesting this discretion on the FDA and as not requiring the FDA to \'93establish rules and regulations for procedures to determine whether a warning instead of a prosecution or injunction serves to vindicate the public interest.\'94}{ \cs17\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ U.S. v. Hu nter Pharmacy, Inc., 213 F. Supp. 323, 324 (S.D.N.Y. 1963).}}}{ }{\fs24 \par }{\fs24 The Second Circuit has held that the FDA\rquote s decision to institute criminal proceedings against a violator does not preclude it from carrying out further inspections of the violator\rquote s facility under Section 374. }{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 U.S. v. Gel Spice Co., 773 F.2d 427, 432 (2d Cir. 1985) }{ \i\kerning0 cert. denied, }{\kerning0 474 U.S. 1060 (1986).}}}{\fs24 This court noted that protecting the health and safety of the public is the FDA\rquote s primary function, and that the FDA should thus not be prohibited from performing this function even temporarily while a prosecution is underway.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\ul\kerning0 .}{\kerning0 at 432.}}}{\fs24 The court further noted that the Supreme Court in }{\i\fs24 U.S. v. Kordel}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 397 U.S. 1, 11 (1970).}}}{\fs24 stated that \'93 it would stultify enforcement of federal law to require a governmental agency such as the FDA invariably to choose either to forgo recommendation of a criminal prosecution once it seeks civil relief, or to defer civil proceedings pending the ultimate ou tcome of a criminal trial.\'94}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Gel Spice Co.,}{\kerning0 773 F.2d at 432.}}}{\fs24 \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\fs24 \tab A district court has upheld the constitutionality of the Drug Abuse Control Amendments Act of 1965,}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 , Public Law 89-74, }{\i\kerning0 supra}{\kerning0 note 124. }}}{\fs24 which does not require the government to show that the sale of a drug covered by the Act (depressant or stimulant drugs) was involved in interstate commerce.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 U.S. v. Erlin, 283 F. Supp. 396, 397 (N.D. Cal. 1968).}}}{\fs24 This court found that Congress made findings supported by evidence that the intrastate sales of LSD have a significant effect on interstate commerce.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at 398.}}}{\fs24 It then concluded that the Drug Abuse Control Amendments Act of 1965 was a constitutional exercise of Congress\rquote power under the commerce clause, both on its face and as applied to purely intrastate manufacture and sale of LSD.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 . at 399.}}}{\fs24 FDA could thus report for prosecution purely intrastate violations of the FDCA as provided by this Act. \par }\pard \ql \li0\ri360\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin360\lin0\itap0 {\fs24 \tab Section 305 of the FDCA, }{\fs24\kerning0 codified at 21 U.S.C. \'a7 335}{\kerning0 ,}{\fs24 provides that \'93 before any violation of this chapter is reported by the Secretary to any United States attorney for institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given appropriate notice and an opportunity to present his views, either orally or in writing, with regard to such contemplated proceeding.\'94 Defendants have attempted to invoke this section in seeking to enjoin criminal proceedin gs that have been instituted against them before they have presented their views before the FDA. The Supreme Court has twice held that the denial of such a hearing is not a bar to criminal prosecution. In }{\i\fs24 U.S. v. Morgan}{\fs24 ,}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 222 U.S. 274, 282 (1911) }}}{\fs24 the Supreme Court in interpreting a similar provision in the 1906 Act, stated that \'93 there is nothing in the nature of the offense under the pure food law, or in the language of the statute, which indicates that Congress intended to grant violators of this act a conditional immunity from prosecution, or to confer upon them a privilege not given every other person charged with a crime.\'94 The Court confirmed this holding in }{\i\fs24 U.S. v. Dotterweich}{\fs24 ,}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 320 U.S. 277, 278-279 (1943) (stating that giving a suspect an \'93 opportunity to present his view\'94 as provided for in 21 U.S.C. \'a7 335, is not a prerequisite to prosecution).}}}{\fs24 this time interpreting the FDCA. \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\fs24 \tab It has further been held that the hearing provided for in Section 335 is not a \'93 full dress trial with all the formal attributes thereof, but only a fair opportunity [for suspects] to present their views.\'94}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\ul\kerning0 }{\i\kerning0 Hunter Pharmacy, Inc.,}{\kerning0 213 F. Supp. at 323-324 (S.D.N.Y. 1963). This court also notes that this hearing is not a prerequisite to criminal prosecution.}}}{\fs24 The Seventh Circuit also noted that the Section 335 hearing is not one that leads to a final administrative orde r, subject to statutory judicial review.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Durovic v. Richardson, 479 F.2d 242, 244 (7th Cir. 1973) }{\i\kerning0 cert. denied, }{\kerning0 414 U.S. 944 (1973) }{\i\kerning0 reh. denied, }{\kerning0 414 U.S. 1099 (1973)}}}{\fs24 \par }{\b\fs24\ul \par Courts\rquote Treatment of FDA\rquote s Debarment Power \par }{\fs24 \tab 21 U.S.C. 335a(a) requires the FDA to debar anyone convicted of a felony with respect to federal regulation of drug products, from "providing services in any capacity to a person that has an approved or pending drug product application." Courts have had the occasion to rule on whether debarment under this section violates the Double Jeopardy}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 This is found in the Fifth Amendment of the U.S. Constitution.}}}{\fs24 and Ex Post Facto}{ \fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 This is found in Article 1, \'a7 9 of the U.S. Constitution.}}}{\fs24 Clauses of the U.S. Constitution. The D.C. Circuit announced that the answer to this question depended on whether debarment is wholly remedial or in part a punitive measure.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 DiCola v. FDA, 77 F.3d 504, 506 (D.C. Cir. 1996).}}}{\fs24 It then concluded after analysis that it agreed with the Seventh Circuit}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 Bae v. Shalala, 44 F.3d 489, 497 (7th Cir. 1995). }}}{\fs24 that debarment under \'a7 335a(a) is solely remedial. Since debarme nt was found to be remedial, imposing debarment after assessing civil penalties, which are punitive, against a violator does not violate the double jeopardy clause of the Constitution.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 DiCola}{\kerning0 , 77 F.3d at 508. }}}{\fs24 Likewise the court concluded that a remedial measure such as debarment cannot violate the ex post facto clause of the Constitution.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id.}{\kerning0 at 508. This conclusion came after the court cited DeVeau v. Braisted, 363 U.S. 144, 160 (1960) for its statement that \'93the mark of an ex post facto law is the imposition of what can fairly be designated punishment for past acts\'94 }{\i\kerning0 Id}{\kerning0 . at 506.}}}{\fs24 \par \tab In a debarment notice published in the Federal Register, the FDA pointed out that debarment does not amount to \'93an unconstitutional taking of the right to earn a living in the U.S.\'94}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 John D. Copanos; Denial of Hearing; Final Debarment Order, }{\kerning0 61 FR 9711, }{\scaps\kerning0 Department of Health and Human Services (HHS), }{\kerning0 FDA, Docket No. 94N-0033, Federal Register Vol. 61, No. 48.}}}{\fs24 It noted that Circuit Courts have held that \'93 the expectation of employment is not recognized as a protected property interest under the Fifth Amendment,\'94}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 The FDA cited to Hoopa Valley Tribe v. Christie, 812 F.2d 1092, 1102 (9th Cir. 1986), and Chang v.}{\ul\kerning0 }{\kerning0 U.S., 859 F.2d 893, 896-97 (Fed. Cir. 1988).}}}{\fs24 and that the Supreme Court has held that the \'93loss of potential profit is not a sufficient basis for a \lquote takings\rquote claim.\'94}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Citing}{\kerning0 , Andrus v. Allard, 444 U.S. 51, 66 (1979).}}}{\b\fs24\ul \par }{\fs24 \par }{\b\fs24\ul Courts\rquote Treatment of FDA\rquote s Publicity Powers}{\fs24 \par }\pard \ql \li0\ri0\sb240\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\fs24 \tab The D.C. district court decided that Section 375(b), which authorizes the FDA to disseminate information regarding food, drugs, devices, or cosmetics when it determines that any such article pres ents an imminent danger to health or gross deception of the consumer, was \'93obviously constitutional.\'94}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 Hoxsey Cancer Clinic v. Folsom, 155 F. Supp. 376, 378 (D. D.C. 1957).}}}{\fs24 The court stated that even without that statutory authority, the FDA could still disseminate such information to the public.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id}{\kerning0 . at 378.}}}{\fs24 The court also noted that in such a situation, a person can sue the FDA for damages if they can establish that the information being disseminated is libelous.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See id.}{\kerning0 at 378. It might not be possible to sue the FDA for damages without its consent, as it is an agency of the federal government and thus covered by sovereign immunity.}}}{\fs24 }{\fs24 A district court has held that it has the power to enjoin the FDA from issuing news releases and other public statements about a manufacturer\rquote s product where such publicity would prejudice a trial against such product.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ U.S. v. Diapulse Mfg. Corp., 262 F. Supp. 728, 730 (D. Conn. 1967) \endash in this case however the court refused to issue an injunction because the manufacturer had failed to show irreparable injury or any threat thereof.}}}{\fs24 \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\ul \par }{\b\fs24\ul Courts\rquote Treatment of FDA\rquote s Regulation of Exports and Imports \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\fs24 The Ninth Circuit has held that the FDCA authorizes the FDA to refuse to admit food being imported upon \'93the mere appearance of adulteration,\'94 a finding of actual adulteration being unnecessary.}{\cs17\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{ Sugarman v. Forbragd, 267 F. Supp. 817, 824 (N.D. Cal. 1967),}{ }{\i aff\rquote d}{, 405 F2d 1189 (9}{\super th}{ Cir. 1968) }{\i cert}{. }{\i denied}{, 395 U.S. 960 (1969) }}}{\fs24 Furthermore, the court found that such a finding is not subject to judicial review.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i Id}{. at 824.}}}{\fs24 }{\fs24 The Second Circuit has held that a court has no discretion to relea se articles that have been condemned due to adulteration, for export to another country.}{\cs17\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ United States v. Kent Food Corp., 168 F.2d 632, 634 (2d Cir. 1948)}}}{\fs24 It stated that while articles intended for export are exempt from some of the provisions of the FDCA, a court cannot accord condemned articles that were not originally intended for export, a \'93delayed exemption for export.\'94}{\cs17\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i Id}{\ul .}{ at 634.}}}{\fs24 It further noted that the FDCA provides that a court can only release condemned articles to the owner for destruction or for being brought into compliance with the FDCA.}{\cs17\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i See,}{ 21 U.S.C. \'a7 334(d)}}}{\fs24 \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\fs24 \par }\pard \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\b\fs24\ul Courts\rquote Treatment of the Intersection Between FTC False Advertising Proceedings and Libel Actions for Misbranding Under the FDCA \par }{\fs24 \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\fs24 \tab The fourth Circuit has stated that a proceeding before Federal Trade Commission (FTC) under 15 U.S.C. \'a7 45, 52 and 53 (to enjoin the use of unfair or deceptive acts or practices and the dissemination of false advertisements to induce the purchase of goods in interstate commerce), does not conflict with libel actions under 21 U.S.C. \'a7 334 (which invoke the power of courts to seize and condemn falsely branded goods which have been unlawfully shipped in interstate commerce in past).}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 U.S. v. 1 Dozen Bottles, etc., 146 F.2d 361, 363 (4th Cir. 1944). }}}{\fs24 This means that these suits can proceed simultaneously. The court further noted that a favorable decision to the manufacturer of the goods that the government is seeking to condemn in a libel suit, has preclusive effect on the promulgation of a cease and desist order by the FTC in a proceeding based on the same charge of misrepresentation of the character of the goods shipped in interstate commerce.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\ul\kerning0 .}{\kerning0 at 363, }{\i\kerning0 citing}{\kerning0 , George H. Lee Co. v. F.T.C., 111 F.2d 583, 586 (8th Cir. 1940) }}}{\fs24 The Court went on to rec ognize that the reverse was also true: An FTC finding that the statements made by a manufacturer are not false or misleading, has preclusive effect on a libel action seeking to condemn goods on the grounds that they are misbranded under the FDCA.}{ \fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 1 Dozen Bottles, etc}{\kerning0 ., 146 F.2d at 363, }{\i\kerning0 citing}{\kerning0 , U.S. v. Willard Tablet Co., 141 F.2d 141, 143 (7th Cir. 1944). }}}{\fs24 \par \tab The Second Circuit has held that a penalty for the violation of a cease and desist order issued under the Federal Trade Commission Act}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 }{\i\kerning0 See}{\kerning0 , 15 U.S.C. \'a7 45(l)}}}{\fs24 does not preclude further remedies for violation of the FDCA. The court stated that \'93 the remedies are plainly cumulative and not exclusive.}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{ \kerning0 U.S v. Five Cases of Capon Springs Water, 156 F.2d 493, 496 (2d Cir. 1946).}}}{\fs24 \par \par }{\b\fs24\ul CONCLUSION \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 {\fs24 The FDCA and all its amendments have continually increased the substantive and enforcement powers of the FDA over the years. FDA\rquote s mission as recognized by congress, is to protect the public health by ensuring that \'93foods are sa fe, wholesome, sanitary and properly labeled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labeled; and public health an d safety are protected from electronic product radiation.\'94}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\super\kerning0 \chftn }{\kerning0 Pub. L. No. 105-115, \'a7 406(a)(2) adding \'a7 903(b) (codified at 21 U.S.C. \'a7 393(b), }{\i\kerning0 supra}{\kerning0 note 290.}}}{\fs24 Further, the FDA is charged with reviewing applications for regulated products in a prompt and efficient manner, as well as working with representatives from foreign countries to \'93harmonize regula tory requirements and achieve appropriate reciprocal arrangements.\'94}{\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 { \super\kerning0 \chftn }{\kerning0 }{\i\kerning0 Id}{\kerning0 .}}}{\fs24 These are very momentous responsibilities that require the FDA to be fully equipped both financially and in its ability to enforce its obligations. \par }{\fs24 With increasing risk to the public health due to technological advances, it is inevitable that Congress will continue to increase the FDA\rquote s responsibilities and to increase its enforcement powers to enable it to meet those responsibilities. With this increase in FDA\rquote s responsibilities, Cong ress will also continue to increase its appropriations to the FDA as well as vesting it with authority to assess and collect user fees for other products it regulates, other than drugs and medical devices, to augment its resources. \par Courts have generally recognized the importance of the FDA\rquote s mission and have construed the FDCA liberally to enable the FDA to carry out its enforcement functions effectively.}{\cs17\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\nowidctlpar\nooverflow\faroman\rin0\lin0\itap0 \fs20\lang1033\langfe2052\kerning28\cgrid\langnp1033\langfenp2052 {\cs17\super \chftn }{ }{\i See, }{U.S. v. Kordel, at 917 (7}{\super th}{ Cir. 1947),}{\cs18\b\cf1 }{\i aff\rquote d}{ , 335 U.S. 345 (1948) }{\i reh. denied}{, 335 U.S. 900 (1948) }{\i and reh. denied}{, 336 U.S. 911 (1949) (noting was passed to protect the public health and should thus be given a \'93liberal construction\'94 despite the fact that it is for the most part penal and imposes criminal penalties). }{\i See also,}{ U.S. v. 7 Jugs, etc., of Dr. Salsbury's Ra kos, 53 F Supp 746, 752 (D. Minn 2d Div. 1944) (stating that the FDCA is one of the most important enactments under the Commerce Clause, with its purpose of protecting the public health against adulterated and misbranded foods and drugs, which has led cou rts to declare with unanimity that food and drug legislation should be given a liberal construction in order to accomplish its remedial purposes).}}}{\fs24 Additionally, where the Supreme Court interpreted the FDCA in a manner that would have made it difficult for the FDA to carry out inspections, Congress amended the FDCA to overturn that interpretation.}{\fs24 \par }}