Pop-Tarts and Elixirs of Death: An Examination of FDA’s Recall Authority

Tina Curatolo
Class of 2005
April 27, 2005

This paper is submitted in satisfaction of the Food & Drug Law course requirement and the third-year written work requirement at Harvard Law School.

ABSTRACT:
In spite of all the regulations that aim to prevent unsafe products from initially entering the market, the Food and Drug Administration must often use its enforcement powers, both formal and informal, to remove hazardous products from the market.  One such enforcement tool, the recall, has played a crucial role in the effective removal of products that pose a danger to public health or otherwise violate the laws FDA administers.  While recall is widely employed by the FDA, it is also widely misunderstood by the public.  It may come as a surprise that, in general, FDA has no authority to order a company to recall an unsafe product.  Most of the recalls we see and hear about today are all voluntary recalls conducted by the company at the request of the FDA.  This paper examines the development of the recall and FDA’s use of the recall in the context of its other enforcement powers.  This paper begins with what can be considered the FDA’s first recall, the infamous Elixir Sulfanilamide tragedy of 1937.  It continues with a description of recall and an explanation of why companies comply with voluntary recall requests.  This paper then studies the specific circumstances in which FDA does have authority to order a recall—situations involving medical devices, infant formula, biological products, and human tissue intended for transplantation—and also looks at FDA’s authority to withdraw approval of a new drug application.  This paper then examines the current debate regarding the granting of a general mandatory recall authority to the FDA.  Finally, this paper briefly examines some of the underlying reasons for recalls.  

Throughout its history the Food and Drug Administration has sought to promote and protect the public health by assuring that the products it regulates are safe and truthfully labeled.  The FDA is responsible for administering and enforcing a number of laws, with the primary one being the Federal Food, Drug, and Cosmetic Act (“FD&C Act,” or “the Act”).  The FDA safeguards almost 80% of the nation’s food supply, regulating all foods not regulated by USDA, which is everything but most meat, poultry, certain egg products, and foods containing 2% or more cooked, or 3% or more raw, USDA-regulated meat or poultry.  FDA also ensures the safety and effectiveness of drugs, medical devices, biological products, and animal drugs and feed, and makes sure that cosmetics and radiation-emitting medical and consumer products do no harm.  In spite of all the regulations that aim to prevent unsafe products from initially entering the market, FDA must often use its enforcement powers, both formal and informal, to remove hazardous products from the market.  One such enforcement tool, the recall, has played a crucial role in the effective removal of products that pose a danger to public health or otherwise violate the laws FDA administers.  While recall is widely employed by the FDA, it is also widely misunderstood by the public.  It may come as a surprise that, in general, FDA has no authority to order a company to recall an unsafe product.  Most of the recalls we see and hear about today are all voluntary recalls conducted by the company at the request of the FDA.  This paper examines the development of the recall and the FDA’s use of the recall in the context of its other enforcement powers.  This paper begins with what can be considered the FDA’s first recall, the infamous Elixir Sulfanilamide tragedy of 1937.  It continues with a description of recall and an explanation of why companies comply with voluntary recall requests.  This paper then studies the specific circumstances in which FDA does have authority to order a recall—situations involving medical devices, infant formula, biological products, and human tissue intended for transplantation—and also looks at FDA’s authority to withdraw approval of a new drug application.  This paper then examines the current debate regarding the granting of a general mandatory recall authority to the FDA.  Finally, this paper briefly examines some of the underlying reasons for recalls.

I.  It Started With a Tragedy

	The story has been told hundreds of times, and it is a story worth telling.  In September and October of 1937, 107 people across 15 states died due to a toxic medicine called Elixir Sulfanilamide.  Manufactured and sold by the S.E. Massengill Company of Bristol, Tennessee, Elixir Sulfanilamide was a liquid form of the country’s latest wonder drug.  Sulfanilamide, a drug used to treat various bacterial infections, was widely available in pill and powder form, but nobody had been able to dissolve the drug to make a liquid version.  Sam Massengill desperately wanted to corner this market in order to provide this drug to children and to people in the South, who apparently preferred drugs in syrup form.  
	S.E. Massengill’s chief chemist, Harold Watkins, known for his bold experimentation with drugs in the laboratory, experimented with various dissolving agents.  Unable to dissolve the sulfanilamide powder in alcohol, Watkins discovered that diethylene glycol (DEG) could be used to dissolve the drug.  DEG is a chemical cousin to antifreeze, an industrial chemical used for keeping products moist, and a deadly poison.  Watkins added some red coloring and raspberry flavor to the mixture, and new syrup was born.  FDA historian John Swann notes: “Elixir Sulfanilamide was essentially slapped together without a thought to testing, without a thought to assessing its toxicity, or certainly without a thought to even looking in the literature to see what you are putting into the product.”  
	Certainly any one of those measures would have revealed that DEG was a poison.  Since the law at the time did not require drugs to be tested for safety, the Massengill lab only checked the product for flavor, appearance, and fragrance.  240 gallons of the product were produced, with over 1500 bottles distributed to pharmacies, distributors, doctors, and salesmen.  
	People started dying, suffering painful, miserable deaths.  It took on average nine days from beginning treatment with the Elixir for people to die of kidney failure.  Doctors in Tulsa, Oklahoma relayed autopsy results to the American Medical Association, which then ordered animal studies to be done on the Elixir.  Simple testing with rats proved DEG to be the poison.  
	Sam Massengill issued recall telegrams to over 1,000 salesmen, druggists, and doctors: “Have withdrawn Product Elixir Sulfanilimide (sic) STOP Please return unused stocks immediately.”  After a New York physician notified FDA headquarters of the deaths, the agency dispatched two investigators to the company’s plant in Bristol.  One of the men, Dr. Theodore Klumpp, FDA chief medical officer, was appalled at the vague language of the recall telegram and made Massengill send another: “Imperative that you take up immediately all Elixir Sulfanilimide (sic) you may have dispensed STOP Product may be dangerous to life.”  
Dr. Klumpp reported back to FDA Commissioner Walter Campbell in D.C.: “The most amazing thing about the company was the total lack of testing facilities. Apparently they just throw drugs together, and if they don’t explode they are placed on sale.”  Based on a trivial charge of misbranding, the FDA sent practically all 239 FDA investigators and chemists all over the country to retrieve the Elixir Sulfanilamide.  Inspectors tracked down Massengill’s salesmen in the field, traveled to rural areas that had not received notice of the recall to attempt to recover the product from patients, poured over shipping records, and traced leads to doctors and pharmacists, who often lied about dispensing the product.  Ten days after this massive effort, all the Elixir shipped and not consumed was accounted for.  It is estimated that if all 240 gallons were consumed, deaths could have exceeded 4,000.  
Approximately six months after the Elixir Sulfanilamide incident, Congress changed the face of food and drug law by enacting a law requiring the FDA to certify the safety of new drugs before they are put on the market.  The Federal Food, Drug, and Cosmetic Act was enacted on June 25, 1938.  Although the creation of the FD&C Act had been under way since 1933, the Elixir Sulfanilamide disaster hastened its adoption and was directly responsible for the addition of certain provisions to try to prevent another such tragedy from reoccurring.  One Congressman notes the weaknesses in the law at that time: 
It is true that certain shipments have been seized on a trivial and technical charge that it was misbranded as an “elixir.”  It is also important that we find out whether these shipments could have been impounded and whether the public could have been protected against their use if the manufacturer had not called his preparation an elixir but had used some other name.  We need to know what are the deficiencies in the present law that have made possible such wholesale tragedies.

That the preparation was misbranded because it did not contain alcohol, which is supposed to be an ingredient in an “elixir,” was, in fact, the only legal basis for FDA’s involvement.  The production and marketing of a lethal drug was not against the law if the manufacturer claimed he did not know the drug was poisonous.  Congress realized that it urgently needed to enact a law with drug safety requirements.  By the end of 1937, Senator Copeland (D-NY) had introduced S. 3073, a bill to safeguard the public health, which forbade the introduction into interstate commerce of any drug composed, in whole or in part, of any substance or combination of substances which is not generally recognized as safe for use.  A similar, more comprehensive bill, H.R. 9341, was introduced in the House by Representative Chapman (D-KY).  These bills formed the basis for the inclusion of the “generally recognized as safe” provisions in the FD&C Act.  
	Since new drugs by definition are not generally recognized as safe, the FD&C Act mandated premarket approval of a new drug to ensure its safety.  The new drug application (NDA) was born.  As originally enacted, the Act required that any person seeking to introduce a new drug into interstate commerce submit reports of investigations as to the drug’s safety, a list of the articles used as components of such drug, a statement of the composition of such drug, a description of methods, facilities, and controls used in its production, samples of the drug and its components as the Secretary may require, and specimens of proposed labeling.  The Secretary can refuse to approve the new drug application for any of the following reasons: the tests for the safety of the drug are not adequate, the tests either show the drug to be unsafe or do not show it to be safe, the methods, facilities, and controls used in the production are inadequate to preserve the drug’s identity, strength, quality, and purity, or insufficient information is available to permit a finding that the drug is safe.  The rationale for each and every one of these provisions can be understood in light of the Elixir Sulfanilamide tragedy.  For example, the obvious safety testing requirements aside, the bottle’s label did not mention that DEG was an ingredient—a specimen of proposed labeling would have revealed that.  
	One of the most fascinating aspects of the formation of the Act, in my view, is that it was enacted months after a massive, life-saving FDA recall, yet it did not include recall as a remedy for violations of the Act.  Moreover, the legislative history appears to be completely devoid of any mention of recalls.  Seizure, criminal proceedings, and exclusion of imports were enforcement powers available to FDA under the Federal Food and Drugs Act of 1906, and they continued to be available under the 1938 Act, which added emergency permit control and injunction powers.  Congress focused primarily on seizures and injunctions in discussing FDA’s authority to remove dangerous products from the market.  
	It was beyond controversy that the Act needed to address drug safety, hence the inclusion of the premarket view and new drug application requirements.  The main controversial and heavily discussed issues concerned the power of the FDA to make multiple seizures, whether control of the advertising of foods, drugs, and cosmetics should be given to the FDA or remain with the FTC, and judicial review of regulations issued by the Secretary of Agriculture under the Act.  
The controversy surrounding multiple seizures would later be referenced by courts to justify the view that courts do not have the authority to order a recall of a violative product.  The multiple seizure issue questioned whether the government may seize a particular lot of misbranded product when seizure proceedings on a different lot of the same product are still pending.  Limiting the power of seizure was a major consideration for Congress.  It was concerned about the hardship that defending multiple seizure cases at the same time in different courts across the country might have on companies.  This was the view of the Court of Appeals for the District of Columbia when it ruled in 1931 that seizing all of a company’s “external remedy” in various courts in widely separated parts of the United States would be unnecessarily oppressive and cause the company great and unnecessary expense, and would ruin and destroy its business and good will.  
From the Spring of 1935, there had been much debate on the issue.  Originally the Senate adopted the “Bailey Amendments” limiting the power of seizure by allowing only one seizure of an offending product, unless the product was imminently dangerous to health. The major concern with these amendments was that the use of a misbranded product, though not imminently dangerous per se, might prevent somebody from using an appropriate remedy and getting necessary care.  By the time the 1938 law was enacted, a compromise had been reached that allayed many of the fears that the multiple seizure limitation would be harmful to the public.  Multiple seizures are allowed where the article has been the subject of a prior judgment favorable to the United States, or where the Secretary has probable cause to believe that the article is dangerous to health or that the labeling of the article is “fraudulent, or would be in a material respect misleading to the injury or damage of the purchaser or consumer.”  Additionally, the multiple seizure limitation does not apply to adulteration cases.  
Multiple seizure limitation aside, the Act broadened the seizure power.  The 1938 Act allows seizure while in interstate commerce, or at any time thereafter, of any article of food, drug, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce.  Under the 1906 Act, the article was required to be adulterated or misbranded at the time of seizure, and could not be seized after it left interstate commerce.  The “at any time thereafter” language of the 1938 Act allows seizure even if the product is in the hands of a happy consumer.  On remand, a district judge, appalled that he had to issue the order of seizure, accompanied the order with a biting criticism of the seizure power: “The policy of entering private homes to seize articles is governmental madness. Just because you have authority does not mean that you have to use it.”  His sentiments seem to have been echoed by Congress with regard to the medical device mandatory recall authority conferred by the Safe Medical Devices Act of 1990—though items can still be seized from individuals, FDA does not have the authority to order recall of a device from individuals.  Instead, it relies on notifying them of the risk associated with the use of the recalled device.  
In addition to broadening the seizure power, Congress granted FDA the authority to seek an injunction to restrain violations of the Act.  “[I]n this bill the committee proposes a new arm of enforcement by providing that injunctions may be used to assist in the enforcement of this act.  This is a very important addition to the present law that should contribute to effective enforcement and reduction of litigation.”  Commenting on how the bill would address a situation such as that which occurred a few years prior, when 25,000 people in 20 states were poisoned, with hundreds killed, Representative Lea (D-CA) stated: 
We have taken care of that in this bill by clothing the Department with a new authority, authority to file an injunction immediately and stop the evil in 24 hours.  In addition to that we have provided severe criminal penalties.  The new drug sections of the bill provide for the examining and testing of these products before they are put on the market.

Representative Reece (R-TN) then added: “I think it is well to bear in mind that the injunction provision which is to be involved in case of emergency, when public health is being endangered, enables the Department to go into court and immediately remove the offending product from circulation.”  
	The legislative history suggests that Congress believed that the key to preventing another Elixir Sulfanilamide incident was to ensure that drugs are safe before they enter the market.  The focus on preventing a tragedy from occurring rather than reacting to a tragedy once it occurred was the proper focus for the times.  By creating the new drug safety provisions, plus strengthening the seizure remedy and adding injunctive relief, Congress believed it was doing everything necessary to protect the public from dangerous products.  Recall was not mentioned because recall did not seem necessary in light of all the other protections the Act offered.  

II.  What Does Recall Really Mean?  

FDA’s General Counsel, William W. Goodrich, testified before Congress as to the origin of the recall, saying, “[T]here were some episodes of poisoning.  We put out a public warning about them, and the next question was to the company: Are you going to get it off the market or shall we seize it?  And from that beginning the recall system grew.”  
In general, FDA has no authority to order a firm to recall a product.  There are specific products for which FDA does have authority to order a recall under certain circumstances—such as medical devices, infant formula, biological products, and human tissue intended for transplantation, which are discussed below in detail—but for the majority of its regulated products, FDA can only request that a company conduct a recall voluntarily.  FDA’s role in recall activities is often misunderstood by consumers, the news media, and sometimes even by the regulated industry.  The following headlines, which appeared in two major daily newspapers, are good examples of that misunderstanding: “FDA Orders Peanut Butter Recall,” and “FDA Orders 6,500 Cases of Red-Dyed Mints Recalled.”  
	Recall is defined as “a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g. seizure.”  Conventional wisdom aside, a recalled product does not have to be unsafe—it has to be violative of FDA’s laws.  FDA published its policies and procedures for recalls in the Code of Federal Regulations.  The regulations state: 
Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.  [The regulations] recognize the voluntary nature of recall by providing guidance so that responsible firms may effectively discharge their recall responsibilities.  

The regulations also recognize that recall is an alternative to a FDA-initiated court action for removing or correcting violative, distributed products:
Seizure, multiple seizure, or other court action is indicated when a firm refuses to undertake a recall requested by the Food and Drug Administration, or where the agency has reason to believe that a recall would not be effective, determines that a recall is ineffective, or discovers that a violation is continuing.  

Because FDA has no authority to order a recall, if the agency requests that a firm recall a product, and the firm refuses, FDA has no authority to impose or seek sanctions for the firm’s refusal to carry out the recall.  FDA, of course, may take legal action respecting the underlying violation that led to the agency’s recall request.  Even though FDA emphasizes that the recall guidelines set forth in 21 C.F.R. Part 7 are not enforceable requirements, some disagree as to the actual voluntariness of such guidelines.  Commenting on similar USDA guidelines on voluntary recalls, one attorney notes: 
As any company that has been involved in a recall will attest, recalls can hardly be considered voluntary. Even when a company initiates the recall and informs USDA of its plan of action, the agency will typically have its own views as to the timing, scope, and depth of the recall, as well as the potential for public notification. When it is the agency that requests the recall, USDA will all but dictate the scope and depth of the recall; and, although the company can discuss with the agency some of these elements, there is usually very little time or realistic opportunity to influence the agency’s recall recommendation.

As with USDA, FDA can play a very large role in a recall, even in a completely firm-initiated recall, by providing guidance, monitoring, and direct assistance to the recalling firm.  FDA monitors and assesses the adequacy of the firm’s actions by suggesting changes to the firm’s recall strategy, notifications, or press releases and assigning audit checks and effectiveness checks to make sure the appropriate people are aware of the recall.  FDA can collect samples of the recalled product or other suspect products, review distribution records, investigate the causes of the problem, certify the destruction or reconditioning of the recalled product, and terminate the recall once a firm has made all reasonable efforts to remove or correct the product on the market.  
FDA also lists all recalls on its weekly FDA Enforcement Report, available online at http://www.fda.gov/opacom/Enforce.html.  This is not to be confused with a press release or other public warning about a recall.  While the decision to publicize the recall is discretionary and usually reserved for more urgent recalls, a listing on the Enforcement Report is routine.  The list describes the product that is being recalled, any identifying codes, the recalling firm or manufacturer, the reason for recall, the volume of product in commerce, and the distribution of the recalled product.    
Another of FDA’s major responsibilities is to conduct health hazard evaluations and classify the recalls on the basis of their potential health threat.  In the classification of recalls, FDA assigns one of three numerical designations to the recall to indicate the relative degree of health hazard presented by the product being recalled.  In the assessment of the health hazard, FDA will take into account such factors as whether any disease or injuries have already occurred, the segment of the population that may be exposed to the product, the degree of seriousness of the health hazard to which the populations at risk would be exposed, the likelihood of occurrence of the hazard, and the consequences of occurrence of the hazard.  In each of the three classifications, the product is violative, as that is built into the definition of “recall.”  
A recall is classified as Class I if there is a reasonable probability that use of, or exposure to, the violative product will cause serious adverse health consequences or death.  A GAO report found that of the 3,248 FDA food recalls from fiscal years 1986 to 1999, about 796, or 24%, are Class I recalls.  A follow-up report examining only fiscal year 2003, however, found a much greater percentage of Class I recalls: of the 296 FDA food recalls in that year, 160 recalls, or 54%, are Class I.  These statistics apply only to FDA food recalls, but it is important to remember that FDA regulates many other products also subject to recall.  To put the 160 food recalls in 2003 in proper perspective, note that the total number of FDA recalls in that year was 2,375.  
Examples of Class I recall classifications are a food found to contain botulin toxin, a food with undeclared allergens, a label mix-up on a life saving drug, or a defective artificial heart valve.  Some examples from the FDA Enforcement Report include: tuna salad that might be contaminated with listeria; Baskin Robbins ice cream that contains undeclared egg; over-the-counter dietary supplements containing undeclared prescription ingredients; 25 mg ephedrine HCl tablets, an over-the-counter expectorant, packed in packets labeled as containing 12.5 mg ephedrine HCl tablets; patient breathing devices that may be obstructed, potentially preventing inhalation; and human cornea tissue from a donor who, though initially tested negative, was later found to have tested positive for hepatitis C.  
A Class II recall is a situation in which the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.  Of the 3,248 FDA food recalls from fiscal years 1986 to 1999, about 45%, or roughly 1,453, are Class II recalls.  Of the 296 FDA food recalls in fiscal year 2003, 101 recalls, or 34%, are Class II.  
Examples of Class II recalls from the FDA Enforcement Report include: a recall of birth control pills that were packaged so that the “start” row mistakenly contained the placebo pills instead of active tablets; eye drops manufactured under non-sterile conditions; blood products collected from donors who lived in a malarial endemic area, or whose health history screening was inadequately performed; food products containing undeclared colors; and egg rolls that contain glass fragments.  
A recall is classified as Class III if the use of, or exposure to, the violative product is not likely to cause adverse health consequences.  Of the 3,248 FDA food recalls from fiscal years 1986 to 1999, about 31%, or roughly 999, are Class III recalls.  Of the 296 FDA food recalls in fiscal year 2003, 35 recalls, or 12%, are Class III.  
Examples of Class III recalls include lack of English labeling in a retail food, off-taste or color in a bottled drink, or the plastic material delaminating on a container.  Some examples from the FDA Enforcement Report include recalls in which: the labeling of the bottle of drug tablets identifies pink tablets, but the bottle actually contains white tablets; there was a lack of assurance that a drug was capable of meeting stability potency through the expiration date; and boxes labeled Kellogg’s Frosted Flakes cereal actually contained Kellogg’s Frosted Bite-Size Mini-Wheat cereal.  This was classified as a Class III recall because no harm would likely result from eating the Mini-Wheats.  Compare this with a similar packaging error that involved nuts, a known allergen, and thus resulted in a Class I recall, when packages labeled as Trader Joe’s Shortbread Tea Cookies with Cranberries actually contained Pecan Shortbread Cookies.  
A firm’s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, is defined and classified as a market withdrawal rather than a recall.  The definition of recall explicitly states that recall “does not include a market withdrawal or a stock recovery.”  Often there is no health hazard, but a company’s management has decided on other grounds that it is to the advantage of the public and the stockholders to recover such material.  
FDA suggests that a firm that initiates a removal or correction of its product which the firm believes is a market withdrawal should consult with the agency when the reason for the removal or correction is not obvious or clearly understood but where it is apparent, e.g., because of complaints or adverse reactions regarding the product, that the product is deficient in some respect.  In such cases, FDA will assist the firm in determining the exact nature of the problem.  Even though a company is not required to notify the FDA if it chooses to conduct a market withdrawal or even a voluntary recall of a product, it is probably in its best interest to do so.  One attorney says regarding market withdrawals, “I feel some compulsion to inform the FDA about such occurrences simply to avert any unwarranted excitement on their part.”    
Sometimes a market withdrawal can really appear to be a recall, especially when it involves a product that poses a health hazard.  This can be seen in Johnson & Johnson’s 1982 “recall” of 31 million bottles of Tylenol after seven people died from taking cyanide-laced capsules.  It turned out that a criminal tamperer, and not the product, was at fault.  A product removed from the market due to tampering, without evidence of manufacturing or distribution problems, is considered a market withdrawal—there has been no violation of the law by the manufacturer.  
A recent high profile market withdrawal that many people may have perceived as a recall was Merck’s September 30, 2004 withdrawal of Vioxx, a prescription anti-inflammatory drug used to relieve pain and arthritis symptoms.  FDA was in the process of reviewing study data indicating that Vioxx was associated with increased risk of serious cardiovascular events, including heart attacks and strokes, to consider further labeling changes, when Merck contacted the agency to request a meeting.  The next day, Merck and FDA officials met and the company informed FDA of its decision to voluntarily withdraw Vioxx from the market because of safety concerns.  
The April 7, 2005 withdrawal of Bextra, a drug like Vioxx with similar cardiovascular concerns, was also considered a voluntary market withdrawal.  However, unlike Merck, the manufacturer of Bextra, Pfizer, Inc., did not come to this decision entirely on its own.  FDA requested that Pfizer voluntarily withdraw Bextra, and although Pfizer disagreed with the government’s position on the risks from the drug, the company complied by suspending sales and marketing of Bextra in the United States, pending further discussions with the agency.    
	The last withdrawal type that is not considered a recall is a stock recovery, also specifically excluded from the definition of recall.  Stock recovery is defined as a firm’s removal or correction of a product that has not been marketed or that has not left the direct control of the firm, i.e., the product is located on premises owned by, or under the control of, the firm and no portion of the lot has been released for sale or use. 
	A company may initiate a recall on its own initiative or at the request of FDA.  A firm that removes or corrects a product because it believes the product to be violative is requested to immediately notify the appropriate FDA district office.  FDA tells its staff: “In all discussions of violative or potentially violative products with the responsible firm, avoid any misunderstanding that FDA is formally requesting a recall action.  FDA requested recalls may be authorized only by the [Associate Commissioner for Regulatory Affairs] or by Center directors delegated that authority.”  
A request by FDA that a firm recall a product is generally reserved for urgent situations, most often classified as Class I recalls.  FDA may request a recall when it determines that a product presents a risk of illness or injury or gross consumer deception, that the firm has not initiated a recall of the product, and that an agency action is necessary to protect the public health.  Generally, FDA will have evidence capable of supporting legal action, such as seizure.  FDA will notify the firm by letter of the need to immediately begin a recall, specifying the violation, health hazard involved, recommended recall strategy, and any other instructions needed to effectively carry out the recall.  FDA district office staff will inspect the company as soon as possible.  In those instances where FDA has the authority to mandate a recall, FDA will issue a written recall order to the firm, specifying the violation, the section of the Act or regulations authorizing FDA to order the recall, the product, lots, and serial numbers to be recalled, and a time frame for the firm’s reply.  
Notwithstanding the voluntary nature of most administrative recalls, FDA may be able to get a court-ordered mandatory recall of any product the agency regulates, under a court’s inherent equity power, when the agency seeks injunctive relief in an enforcement action.  Additionally, FDA argues that a court has authority and jurisdiction under section 302 of the Act, which allows a court “to restrain violations” of the Act in injunction proceedings.  However, there is some dispute among the courts as to their authority to order a recall of an adulterated or misbranded product under either their general equitable powers or section 302 of the Act.  
One view is that the courts do not have authority to order a recall since there is no mention in the Act of recall as a remedy, and the legislative history suggests that Congress did not intend for something as harsh as recall to be a remedy.  Refusing to rely on inherent equitable powers, one court said that “resort to ancillary remedies through equitable powers is unnecessary to enforce the spirit, as well as the letter, of the Act. The FDA’s statutory remedies provide for sufficient means to enforce the Act, and the legislative history and the Act itself manifest a reluctance to expand enforcement powers to the point where they are punitive.”  
A report of the House Committee on Interstate and Foreign Commerce states the objectives sought by Congress in providing for injunction as an enforcement procedure:
This procedure will be particularly advantageous in border-line cases that cannot be settled without litigation.  In many such cases it is unfair to the manufacturer to subject him to criminal trial and likewise unfair to the public to have the issue determined under the restrictions necessarily prevailing in criminal procedure.  This remedy should reduce litigation.  In some cases it should avoid the hardship and expense to litigants in seizure cases.  In many instances seizure is a harsh remedy and should be discouraged or confined to those cases where the public protection requires such action.  In many cases, it is believed…injunctions can be used with equal effectiveness and with less hardship.  A seizure case finally decided in favor of a defendant leaves him without recourse for his losses, including court costs, storage, and other charges.  

The courts that raise the legislative history of the Act mention that it shows that Congress intended injunction to provide relief from the hardship of seizure actions.  They reason that ordering a recall in an injunction, when that injunction proceeding should have provided relief from seizure, would make the injunction as harsh as seizure.  The underlying assumption here seems to be that recall is worse than, or at least as bad as, seizure for a company.  Taking into account such factors as negative publicity and the financial savings realized from possibly reconditioning and reselling, instead of destroying, violative product, I am not convinced that recall is, in fact, more burdensome to a company than seizure.  
Other cases have held that a court is entitled to order a recall under both section 302 of the Act and inherent equity powers.  Interestingly enough, a different judge in the same district court that had ruled on C.E.B. Products ruled that the section 302 authority to “restrain” violations “is broad enough to cover affirmative or mandatory relief…More significantly, we believe that our general equity jurisdiction suffices for the authority to order a recall, since the statute by which we are given jurisdiction over this controversy does not preclude such relief.”  Additionally, the Sixth Circuit, holding that nothing in the Act precludes a court sitting in equity from ordering restitution in appropriate cases, noted that the legislative concerns of the harshness of injunctions and seizures “are far from a clear statement of Congress’s intent to exclude restitution, recalls, disgorgement, or any other traditional form of equitable relief.”  
	Although getting a court-ordered recall can be beneficial in conjunction with an injunction proceeding, court-ordered recalls are not the type of recalls that the FDA relies upon to clear the market of hazardous products.  It is the informal, voluntary administrative recall that has become a routine enforcement tool for the agency.  

III.  A Rock and a Hard Place: Voluntary Compliance With FDA Recall Requests

Generally, in the instances where FDA has the authority to order a recall, a company’s failure or refusal to comply with the recall order is a prohibited act under 21 U.S.C. § 331, thereby subjecting the violator to regulatory actions by FDA.  Contrary to this explicit penalty, it is the implicit threat of regulatory action, liability, and adverse publicity that compels a company to comply with an FDA request to recall a product.  
For significant violations, which are those violations that may lead to enforcement action if not promptly and adequately corrected, FDA may send a “Warning Letter” to a firm.  This informal warning letter is FDA’s primary means of achieving prompt voluntary compliance with the Act.  The letter describes the violative product, practice, or condition and the specific section of the law or regulation violated.  The warning letter requests that the company correct the violation and submit a written response to the FDA, usually within 15 working days of receipt of the letter.  Although the warning letter does not commit the agency to enforcement, the letter can state that failure to achieve prompt correction may result in enforcement action without further notice.  
Such enforcement action can include an injunction, which may shut down a manufacturer’s plant completely for an indefinite period of time.  It may also include mass seizure, in which all of the manufacturer’s products across the country may be subject to seizure by federal marshals pursuant to the authority of the various federal district courts.  Or it may include potential criminal prosecution both on a corporate and on an individual basis.  
One of FDA’s most recent grants of power occurred as a response to the tragic events of September 11, 2001.  The Bioterrorism Act, signed into law on June 12, 2002 enhanced the security of the food supply by amending the FD&C Act to add detention authority for foods.  FDA has the authority to order the detention of any article of food that is found during an inspection, examination, or investigation, for up to 30 days, if FDA “has credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals.”  This period of detention enables the FDA to institute a seizure or injunction proceeding.  
Responding to a comment that FDA should continue to rely on the proven capabilities of Class I recalls and cooperation with the food industry to handle a potential hazard, FDA notes that “class I recalls are voluntary measures only. In the Bioterrorism Act, Congress has given FDA the means both to establish requirements for establishment and maintenance of records, and to administratively detain, on its own initiative, food for which FDA has credible evidence or information that the food presents a threat of serious adverse health consequences or death….”  FDA also points out that the records required by the Bioterrorism Act will not only help remove contaminated food from the market, but will also help identify the source of the contamination.  
USDA has possessed the authority to administratively detain foods for much longer than FDA.  The Under Secretary of Agriculture for Food Safety notes how the detention authority can be useful even when the company recalls the product:  
Well, certainly having that detention authority is extremely important…We, of course, let the company know that they need to issue a recall, and all of them do, but let me give you an example…of an instance where we have exercised that authority very recently.  There was a bologna-type product that came from Brazil that did not go through our inspection which was not supposed to happen, certainly. As soon as we found out about it, not only did we inform the company that they needed to recall the product, but we sent all of our compliance officers to all 30 stores where the product was and physically removed it. So it is an authority that we avail ourselves of, and I intend to use it as much as possible, and I believe that is one way that people can, “effect as efficient and thorough a recall as possible with present authorities.”

It is usually in a firm’s best interest to cooperate with the FDA.  If a firm cooperates, then FDA may choose not to exercise its discretionary powers, like recommending criminal prosecution.  “The prospect of a recall seems less frightful when viewed in the context of these other regulatory tools—tools about which there is no question of the FDA’s legal authority.”    
A firm might also want to comply to avoid potential products liability lawsuits and civil liability by getting the violative product off the market as quickly as possible.  It is in the company’s interest to get an arguably hazardous product out of the hands of potential plaintiffs.  A company may minimize damages, and certainly punitive damages, by using the fastest, most effective procedures.  
Avoiding bad publicity is another incentive for a firm to cooperate with FDA requests.  Cooperation is perceived to affect the FDA’s decision as to the extent to which it will publicize the violation.  However, it is important to note that publicity does not only serve a punitive or deterrent purpose—if a firm is cooperating in an expeditious recall, there may be less risk for the public and thus less need for adverse, extended publicity.  

IV.  The Effects of Publicity: Powdered Milk and Canned Soups

The Act authorizes two kinds of publicity: notices of judgments and public warnings.  The Secretary may periodically publish reports summarizing all judgments, decrees, and court orders rendered under the Act, including the nature of the charge and the disposition thereof.  
The main purpose served is that of an additional deterrent to violations of the Act, for in general it may be said that the publicity resulting from the notices of judgment is frequently superior in its deterrent effect to that of the penalties imposed.  This follows because public knowledge that the product has been involved in a violation of the law serves to prejudice it in the eyes of wholesalers and retailers and to some extent the consumers, and the data contained in the notices of judgment are doubtless made use of by trade competitors.  

The Act also authorizes the Secretary to disseminate information regarding food, drugs, devices, or cosmetics in situations involving, in the opinion of the Secretary, imminent danger to health or gross deception of the consumer.  Such a public warning occurred, for example, in 1995 with a dietary supplement that contained ephedra, before the FDA issued its regulation prohibiting the sale of dietary supplements containing ephedrine alkaloids.  This regulation was finally issued on February 6, 2004, concluding that supplements with ephedrine alkaloids present an unreasonable risk of illness or injury and are therefore adulterated under the Act.  The FDA is selective with its publicity in part because it does not want to saturate the public with so much negative information that the public becomes indifferent or insensitive to important warnings about a potentially dangerous product.  
One example of the chilling effects that publicity can have on public trust of a brand name is the Borden Starlac incident of 1966.  Samples of Starlac, a leading brand of powdered milk, were found to contain salmonella.  Although no illnesses had been attributed to Starlac, recall was recommended by FDA as a precaution.  The first major public notification of the recall appears to be Thursday, November 3, 1966.  The FDA had been checking several hundred dry milk processors for salmonella since February, when the CDC warned that dry milk might be a potential carrier of the salmonella bacteria.  FDA had been conducting tests at Borden’s Dixon, Illinois plant since August.  A Borden spokesperson said that FDA first got indications that salmonella contamination might exist at the Dixon plant or in its product around the beginning of October.  FDA first discussed recall with the Borden company during the week of October 24.  Borden called its district offices on Thursday, October 27 to tell them the product was being recalled.  
Borden said that its salesmen and food distributors then began “sequestering” Starlac from stores and markets.  However, official notice went out by teletype on Monday, October 31.  Borden closed its Dixon plant to investigate it to find the source of the contamination. Borden arranged to take back all the stocks of Starlac and reimburse all retail stores.  
Borden said it had found traces of salmonella in only three of the 123 samples of Starlac. It said it thought Starlac had been removed from virtually all of the approximately 67,000 retail stores that carried it.  As a precaution, Borden also recalled another one of its products, Frosted Shakes, a drink similar to a milkshake, since it was processed at the same Dixon plant.  
Thursday’s front page article of the New York Times which revealed the recall contained a warning by Kenneth R. Lennington, the FDA Salmonella Project Officer, which “urged housewives not to use any Starlac they might have.”  By Friday a manager at an Upper West Side grocery store was complaining, “The women have been driving me crazy.  All day they’ve been coming in and returning the boxes for a refund.”  It appears these housewives took Lennington’s urging seriously.  At another Upper West Side grocery store, when a customer attempted to buy the single box of Starlac in sight, the clerk explained that it might be “contaminated” and said it should not have been on the shelf.  She added, “My son had Salmonella poisoning when he was 5 years old and it was just awful.”  
The Starlac brand soon after disappeared from the market.  The negative publicity resulting from the salmonella scare was more effective than any seizure or recall action alone to get the products out of the hands of consumers and to kill the Starlac brand name.  The entire powdered milk industry, which had thrived due to the low cost and nonfat nutrition of the milk, was never the same.  
	The Bon Vivant Company of Newark, New Jersey, manufacturer of canned soups, provides another notable illustration of the devastating effects publicity can have on a company.  On July 2, 1971 FDA released a public warning after learning that a New York man had died and his wife had become seriously ill due to botulism after eating a can of Bon Vivant vichyssoise soup.  The company commenced a recall of the 6,444 cans of vichyssoise soup made in the same batch as the can known to be contaminated.  The FDA soon discovered that the company’s processing practices raised questions not only about the lots of the vichyssoise, but also about all other products packed by the company.  The effectiveness check of the recall had revealed a number of swollen or otherwise suspect cans among Bon Vivant’s other products, so FDA extended the recall to include all Bon Vivant products.  The FDA shut down the company’s Newark, New Jersey plant on July 7, 1971.  Although only five cans of Bon Vivant soup were found to be contaminated with the botulin toxin—all in the initial batch of vichyssoise recalled and part of the first 324 cans tested—the ordeal destroyed public confidence in the company’s products and the Bon Vivant name.  Bon Vivant filed for bankruptcy within a month of the announcement of the recall.  
The incident did not take a toll only on the company, however.  Bon Vivant did not have adequate records and controls of production lots and distribution in order to trace the products quickly.  The company also did not have the finances or manpower necessary to run a successful recall program.  As a result, the FDA had to seize all the Bon Vivant soup throughout the country, more than a million cans in all.  FDA said the seizure occupied 125 man years of FDA time, enough for 2,000 ordinary factory inspections for preventive purposes.  After some squabbling in the courts, where the owner of the company sought to recover the seized cans for resale under the company’s new name, “Moore & Co.,” the soup was eventually incinerated, at the cost of nearly $150,000 to the federal government.  As for Moore & Co., it appears the resurrection of the company was short-lived.  
The Bon Vivant incident illustrates that seizure is a good backup power in cases where a recall does not sufficiently remove a product from the market, yet seizure may also be inefficient at removing a product after it has been widely distributed.  The regulations recognize that “[r]ecall is generally more appropriate and affords better protection for consumers than seizure, when many lots of product have been widely distributed.”  In seizure actions FDA must identify the quantity of a product at each location and recommend a seizure action for each location.  Additionally, since FDA must initiate a seizure through the U.S. Attorney’s Office, which employs U.S. marshals to effect the seizure, the process usually takes over two weeks, even on an emergency basis.  During this time, the product can be moved and sold, unless it happens to be a product that FDA can detain, such as foods under the Bioterrorism Act of 2002.  
In stark contrast to the problematic recall and damaging publicity suffered by the Bon Vivant Company, in August 1971, after the Campbell Soup Company discovered botulin in a test can of its chicken-vegetable soup, the company successfully recalled the batch of 4,799 cans of soup.  The CEO of Campbell was notified within minutes of the discovery of the botulin-contaminated can, and by the next evening FDA had been notified and the trade and public notification procedures were begun.  Campbell had adequate, reliable records and knew exactly how much of their product had gone out and where it went.  All news services were notified and consumers were asked to destroy all products—not just products with certain codes or dates of production—and exchange the label for a refund.  In addition, Campbell refunded wholesalers and retailers the full selling price of the product, giving them maximum incentive to remove the product from circulation.  A survey showed that 92% of the sample group were aware of the recall situation.  The recall campaign cost Campbell $5 million, but it did not leave the company with a negative public image.  “Little adverse effects resulted, largely because the FDA’s subsequent announcements commented favorably on Campbell’s compliance with the recall program.”  Indeed, to this day the soup is “m’m m’m good” in practically every country in the world.  The most successful recall, noted one attorney, is mentioned once in the FDA Enforcement Report, may briefly be noted by the trade press and those in the distribution chain actually involved in the recall, and disappears from public concern shortly thereafter.  
Following the Bon Vivant incident, regulations were enacted to set forth good manufacturing practices (GMP) for low acid canned foods, and to specifically apply the emergency permit control regulations of section 404 of the Act to low acid canned foods.  The manufacturing protocol was based on the widely accepted practices for processing low acid canned foods that had been developed by the National Canners Association and other food industry scientists.  Especially in light of the Bon Vivant incident, where the company was found to have defective can sealing and cooking equipment and unreliable records, many believed that only the mandatory imposition of the procedures would ensure that all canners observe the standards.  Part of the reason why the canning industry supported, indeed, proposed, the mandatory imposition of canning procedures was due to the damaging publicity of the incident—it seemed essential for the industry to emphasize its commitment to the safety of canned foods.  
The effect of the two regulations is that if processors of low acid canned foods do not comply with the GMP requirements of 21 C.F.R. Part 113, they are subject to the emergency permit control regulations of 21 C.F.R. Part 108, with the result that they would be prohibited from shipping product except in accordance with the permit issued by the FDA.  The FDA stated that “[b]otulism in canned goods has been effectively controlled under the low acid canned food regulations and is no longer a particular source of consumer concern.”  

V.  The Recall Strategy

	Once a company has decided to recall a product, it has a number of responsibilities, set forth in the voluntary recall guidelines in 21 C.F.R. Part 7.  Among them are development of a recall strategy, providing FDA with complete details of the recall and the recalled product, notifying direct accounts of the recall and providing guidance regarding further distribution and return of the product, and submitting periodic status reports so FDA may assess the progress of the recall.  
Each recall must have a recall strategy.  A firm is not required to consult with FDA or modify its recall strategy on the basis of FDA’s recommendations, but it is generally in its best interest to do so.  FDA will review a firm’s recall strategy and recommend changes as appropriate.  A recall strategy must address the following three elements of a recall: the depth of recall, public warning, and effectiveness checks.  
Depth of recall specifies the level in the distribution chain to which the recall is to extend, such as the consumer level, retail level, or wholesale level.  This depends on the product’s degree of hazard and the extent of its distribution.    
The recall strategy must also specify whether a public warning is needed.  The public warning, typically in the form of a press release, alerts the public that a product being recalled presents a serious hazard to health.  Therefore, the public warning tends to be reserved for the more urgent situations, where other means for preventing use of the recalled product appear inadequate.  The FDA in consultation with the recalling firm will ordinarily issue such publicity, but if the recalling firm decides to issue its own public warning, FDA requests that it submit its proposed public warning and plan for distribution of the warning for review and comment by the agency.  If a public warning does not get enough media attention, or if the firm does not include sufficient information in its public warning, FDA may issue another one, which will most likely cast a negative light on the company.  The public warning can be issued through general national or local news media, through specialized news media, such as professional or trade press, or to specific segments of the population, such as physicians and hospitals.  GAO notes that “FDA does not require public notification of a recall when the product is (1) not expected to be in the hands of consumers; (2) in bulk and the consumer is unable to distinguish the recalled product from the nonrecalled product; (3) an ingredient used by food manufacturers, and the firms’ distributors can be contacted in an expeditious manner; and (4) sold through mail order, and the firm can contact recipients in an expeditious manner.”  
Below is an example of a recall press release, issued by Kellogg for its 2002 recall of Pop-Tarts, my favorite preserved breakfast pastry.  This was a Class I recall that warranted public warning because the product contained undeclared egg, a common allergen.  This press release follows pretty closely the FDA model recall press release concerning allergens.  
Kellogg USA Issues Allergy Alert on Undeclared Egg in 
Kellogg's® Pop-Tarts® Frosted Brown Sugar Cinnamon
NEWS RELEASE

Contact:  Jenny Enochson
(269) 961-3799
                
For Immediate Release

Kellogg USA Issues Allergy Alert on Undeclared Egg in Kellogg's® Pop-Tarts® Frosted Brown Sugar Cinnamon

BATTLE CREEK, Mich. - December 6, 2002 -- Kellogg USA of Battle Creek, Mich., is recalling Kellogg's® Pop-Tarts® Frosted Brown Sugar Cinnamon 8-count, 14-ounce packages because they contain undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume this product. 

There are 730,000 packages of 8-count, 14-ounce Kellogg's® Pop-Tarts® Frosted Brown Sugar Cinnamon with a UPC code of 38000 31110 and a carton code of K-3111D printed on the top of the package affected by this allergy alert. The only Better If Used Before Dates affected are:

SEP 23 03 CT 	NOV 23 03 CP	
OCT 27 03 CP	NOV 24 03 CP	
OCT 28 03 CP	NOV 25 03 CP	
NOV 06 03 CT	NOV 26 03 CP	
NOV 07 03 CT	NOV 27 03 CP	
NOV 08 03 CT		

These packages were distributed throughout the U.S. and Caribbean.

No illnesses or allergic reactions have been reported to date in connection with this problem. 

This recall was initiated after an internal review revealed that product containing egg was inadvertently placed in packages that do not declare the presence of egg. The only affected product is the 8-count package bearing the code K-3111D, and with the specific Better If Used Before dates indicated above.

Consumers who have purchased the recalled product can contact Kellogg Consumer Affairs at 1-877-877-4494 for further information and instructions.

Some consumer groups believe that these press releases are not particularly useful to consumers because they lack information that would help them determine if the recalled product is in their homes.  These groups advocate that the press release should list store locations where the recalled product was sold, and that recall information should be prominently displayed at stores that sold the product.  There are, however, issues regarding confidential business information that may prevent the government from publicly identifying stores that sold the recalled product.  
The last element of the recall strategy is effectiveness checks.  The purpose of effectiveness checks is to verify that all consignees at the recall depth specified by the strategy have received notification about the recall and have taken appropriate action.  The strategy must specify the methods to be used for effectiveness checks and the level of effectiveness checks that will be conducted.  Effectiveness checks may be accomplished by such methods as personal visits, telephone calls, or letters.  While the recalling firm is usually responsible for the effectiveness checks, FDA may assist as necessary.  The level of effectiveness checks can essentially vary from 100% of the consignees being contacted, to no effectiveness checks being conducted at all, or any percentage in between.  A situation where no effective checks would be done, for example, would be if FDA believes that a recalled food is no longer on store shelves, such as bagged salad that is two weeks past its expiration date.  

VI.  But It’s Not Always Voluntary: Specific Circumstances of Mandatory Recall Authority

	As this paper has emphasized thus far, recalls are generally voluntary actions on the part of companies, at least voluntary in that FDA by and large has no statutory authority to order a company to recall its product.  However, there are a few products which, over the years, Congress has decided warrant special protection.  Therefore, medical devices, infant formula, biological products, and human tissue intended for transplantation are all subject to mandatory recall by the FDA.  

VI.-A.  Mandatory Recall of Medical Devices 

A device is any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article, including any component, part, or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or which is intended to affect the structure or function of the body, which does not achieve its primary intended purposes through either chemical action within or on the body or through a dependency upon being metabolized.  In other words, a medical device includes almost everything, other than drugs, used by health care professionals to diagnose and treat illness, improve human functioning, and support and sustain life.  
FDA ensures the safety and effectiveness of medical devices by both premarketing review and postmarketing surveillance.  Premarketing review applies checks and controls before a device is made available to the public, and postmarketing surveillance monitors for problems associated with a device after it is in general use.  Medical device recalls fall into this latter system.  
Section 8 of the Safe Medical Devices Act of 1990 amended section 518 of the FD&C Act by adding a new subsection (e) entitled “Recall authority.”  Section 518(e) gives the FDA the authority to recall medical devices.  It provides that:
(1) If the Secretary finds that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the device)—
(A) to immediately cease distribution of such device, and 
(B) to immediately notify health professionals and device user facilities of the order and to instruct such professionals and facilities to cease use of such device.

The section further states that after giving the person subject to the order the opportunity for an informal hearing, the Secretary will either vacate the order or amend it to require a recall of the device.  
The Secretary may not recall a device from individuals, and may not recall a device from device user facilities if the Secretary determines that the risk of recalling such device from the facilities presents a greater health risk than the health risk of not recalling the device from use, unless the device can be replaced immediately with an equivalent device.  Although a mandatory recall order will not require recall of a device from an individual, a mandatory recall order shall provide for notice to individuals subject to the risks associated with the use of the recalled device.  
As a practical matter, under delegated authority the directors or deputy directors in the appropriate FDA centers and offices of compliance, and not the “Secretary” make these decisions.  This delegation from the Secretary of Health and Human Services to the FDA is reflected in the Code of Federal Regulations.  
Device user facilities, importers, and manufacturers are all subject to mandatory medical device reporting regulations that require them to notify the FDA and/or the manufacturer when they identify a potentially unsafe device.  The requirements differ slightly for each group, with the greatest burden falling, expectedly, on the manufacturer.  Device user facilities are required to submit reports of device-related deaths and serious injuries; importers must submit reports of device-related deaths, serious injuries, and malfunctions; and manufacturers must submit reports of device-related deaths, serious injuries, malfunctions, and events that require a remedial action to prevent an unreasonable risk of substantial harm to the public health.  These mandatory reporting requirements no doubt assist the FDA with identifying potentially harmful products to recall.  
21 C.F.R. Part 810 describes the procedures the FDA will follow in exercising its medical device recall authority under section 518(e) of the Act.  The regulations note that FDA may deny a request for hearing if the Commissioner or presiding officer determines that no genuine and substantial issue of fact is raised by the material submitted in the request.  Ordinarily, the FDA will hold the regulatory hearing no fewer than 2 working days after receipt of the request for a hearing and no later than 10 working days after the date of issuance of the cease distribution and notification order.  In some instances, however, FDA and the person named in the order may agree to a later date, or the FDA can determine that the hearing should be held in fewer than 2 days.  
When FDA determines that a mandatory recall is warranted, FDA must amend the cease distribution and notification order to require a recall within 15 working days of completing a hearing or denying a request for a hearing, or within 15 working days after receiving a written request for review of a cease distribution and notification order under 21 C.F.R. § 810.12, or within 15 working days after the issuance of the cease distribution and notification order if a hearing or agency review of the order is not requested.  
The person subject to the mandatory recall order is responsible for developing an appropriate recall strategy and submitting it to the FDA for review and possible revision.  Like the recall strategy for voluntary recalls, the strategy must specify the level in the chain of distribution to which the order is to extend, provide for notice to individuals subject to the risks associated with use of the recalled device, and specify the methods the person subject to the order will use to conduct the required effectiveness checks to verify that all health professionals, device user facilities, consignees, and individuals, as appropriate, have been notified of the recall order and the need to take appropriate action.  The person named in the order is also responsible for submitting periodic status reports to the FDA.  
In response to comments implying that the regulations needed to clarify the criteria for issuing mandatory recall orders, FDA explained that a recall may occur only after FDA has: (a) made the requisite finding of serious adverse health consequences or death, (b) issued a cease distribution and notification order, (c) provided an opportunity for hearing, and (d) determined that a recall from a device user facility will not present a greater health risk than the health risk of not recalling the device from use.  FDA further clarified that it may amend a cease distribution and notification order to include a mandatory recall in three circumstances: (1) if the individual named in the order complies with the order and requests a regulatory hearing, but is unable to demonstrate that all devices subject to the order do not pose a reasonable probability of causing serious, adverse health consequences or death, (2) if the individual named in the order does not comply with the order and does not request a regulatory hearing, and (3) if the individual named in the order complies with the order and initiates a voluntary recall which is found to be ineffective.  In all the circumstances described above, FDA has the authority to amend the cease distribution and notification order to include a mandatory recall because the devices continue to pose a reasonable probability of causing serious, adverse health consequences or death.  
“FDA expects that almost all of the recalls will continue to be carried out under the voluntary recall, part 7 procedures.  The agency expects that at most one or two recalls per year would be ordered that would not have occurred without this regulation.  Thus, the agency believes that this new authority will not be used frequently.”  In practice, with the exception of urgent situations, the majority of recalls are initiated voluntarily by manufacturers with FDA oversight.  
An interesting question regarding the enactment of the mandatory recall provision is why Congress found it particularly necessary in light of the “repair, replacement, or refund” provision added by the 1976 Medical Device Amendments.  Section 518(b) of the Act allows the Secretary to order the manufacturer, importer, or distributor of any device to repair, replace, or refund the purchase price of a device if all of the following four conditions are met: 
(i) a device intended for human use which is introduced or delivered for introduction into interstate commerce for commercial distribution presents an unreasonable risk of substantial harm to the public health, 
(ii) there are reasonable grounds to believe that the device was not properly designed or manufactured with reference to the state of the art as it existed at the time of its design or manufacture, 
(iii) there are reasonable grounds to believe that the unreasonable risk was not caused by failure of a person other than a manufacturer, importer, distributor, or retailer of the device to exercise due care in the installation, maintenance, repair, or use of the device, and 
(iv) the notification authorized by subsection (a) of this section would not by itself be sufficient to eliminate the unreasonable risk and [the repair, replacement, or refund of the purchase price of the device] is necessary to eliminate such risk….  

Congress believed that requiring the FDA to meet the strict requirements of this section before it could mandate correction of a potentially hazardous device did not adequately protect the public health.  The House of Representatives noted a particular difficulty with the “state of the art” requirement of section (ii) above: 
[E]ven when the FDA has discovered a serious health hazard associated with a medical device, the Agency faces a unique barrier to enforcing important administrative remedies. Unlike other health and safety agencies, FDA may not take administrative action to order a defective device recalled unless it can show that the device did not meet the state-of-the-art at the time it was designed and manufactured.  

Additionally, the Senate noted that “the ‘repair, replacement, or refund’ provisions of section 518(b) of the Act have never been used.  Section 518(b)’s intricate findings and procedures have served as an inappropriate deterrent to its use.”  Therefore, Congress determined that a more simplified and strengthened recall authority was needed.  Congress explicitly stated that, under the new recall authority, FDA “will have considerable discretion in determining whether it is more likely than not that the continued distribution of a device would cause serious, adverse health consequences or death.”  

VI.-B.  Mandatory Recall of Infant Formula

Following the 1979 recall by Syntex Laboratories of three soy-based infant formulas that, because of an inadequate level of chloride, resulted in a number of cases of metabolic alkalosis, Congress enacted the Infant Formula Act of 1980.  This law added section 412 to the FD&C Act, enlarging FDA’s regulatory authority over the formulation and production of infant formula.  This act did not, however, give the FDA authority to order a recall of infant formula.  FDA’s recall authority was limited to requiring that a firm follow certain recall procedures once the firm, in its discretion, had chosen to initiate a recall of infant formula.  In response to a number of concerns expressed by members of Congress and consumers about the ability of the 1980 act, including the recall provision, to protect children “from ever again being threatened by defective baby formula,” Congress revamped section 412 as part of the Drug Enforcement, Education, and Control Act of 1986.  The 1986 amendments gave FDA the authority to order manufacturers to recall infant formula when the agency determines that the infant formula presents a risk to human health.  
The Act provides that: 
If the manufacturer of an infant formula has knowledge which reasonably supports the conclusion that an infant formula which has been processed by the manufacturer and which has left an establishment subject to the control of the manufacturer—
(A)	may not provide the nutrients required by subsection (i) of this section, or 
(B)	may be otherwise adulterated or misbranded, 
the manufacturer shall promptly notify the Secretary of such knowledge.  If the Secretary determines that the infant formula presents a risk to human health, the manufacturer shall immediately take all actions necessary to recall shipments of such infant formula from all wholesale and retail establishments, consistent with recall regulations and guidelines issued by the Secretary.  

The Act requires a manufacturer recalling an infant formula that presents a risk to human health to request that each retail establishment that sells the infant formula post a notice of such recall.  The Act also requires the manufacturer to submit to the FDA status reports every 14 days describing the progress of the recall.  
The Act further states that once a manufacturer begins a recall of infant formula, it must carry out the recall in accordance with the requirements prescribed by the Secretary.  Such requirements include evaluating the health hazard associated with the use of the infant formula, devising an appropriate recall strategy, notifying all of its affected consignees about the recall and advising them on how to return or otherwise dispose of the recalled infant formula, and conducting effectiveness checks to ensure the recall is carried out.  These requirements apply to any recall of infant formula, including a firm-initiated voluntary recall.  
However, if the removal of infant formula from the market is not classified as a recall, the manufacturer is not required to follow the specific recall procedures set forth in the regulations, though the manufacturer still must notify the FDA of the adulterated or misbranded infant formula pursuant to 21 U.S.C. § 350a(e)(1), 21 C.F.R. § 107.240(a).  The FDA explains: 
Under longstanding agency policy, a firm’s removal from the market of a product that is violative in some minor way (e.g. inconsequential deviations from good manufacturing practices), but would not be subject to seizure under current agency policy, is deemed to be a market withdrawal and not a recall.  To constitute a recall, the subject product must be both violative and actionable (21 C.F.R. 7.3(g)).  Thus, even though this rule may require an infant formula manufacturer to notify FDA of a technical or minor instance of adulteration or misbranding, such notification will not necessarily trigger an FDA-required or even a firm-initiated recall.  

The regulations further clarify that in such cases the manufacturer “may, but is not required to, conduct such market withdrawal consistent with the requirements” set forth by FDA pertaining to infant formula recalls.  
Infant formula was viewed as a special class of foods, thus deserving greater protection.  Infant formula often serves as the sole source of nutrition during crucial stages of infancy.  In the legislative history of the 1986 amendments, Senator Metzenbaum explained why infant formula needs more regulation than other foods: “there is simply no margin for error in the production of baby formula. An infant relies on the formula to sustain life and provide the proper nourishment at a time of rapid physical and mental development.”  

VI.-C.  Mandatory Recall of Biological Products

The National Childhood Vaccine Injury Act of 1986 amended the Public Health Service Act to provide recall authority for biological products.  Thus, unlike the previous two mandatory recall authorities, FDA’s authority to order the recall of biologics is found under the Public Health Service (PHS) Act, and not the FD&C Act.  
	The PHS Act defines a biological product as “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.”  
The PHS Act provides that “[u]pon a determination that a batch, lot, or other quantity of a product licensed under this section presents an imminent or substantial hazard to the public health, the Secretary shall issue an order immediately ordering the recall of such batch, lot, or other quantity of such product.”  FDA has not elaborated on its recall authority for biological products in implementing regulations.  
As with both medical devices and infant formula, there are mandatory reporting requirements for biological products.  A licensed manufacturer is required to report to FDA information regarding adverse experiences with biological products.  This includes life-threatening, serious, and unexpected adverse experiences.  

VI.-D.  Mandatory Recall of Human Tissue Intended for Transplantation

In 1993, after FDA learned of the uncontrolled importation of human tissue into the United States and the inadequate testing and screening of foreign tissue donors, FDA sought greater regulation over human tissue in order to protect the public from tissue unsuitable to transplantation.  Under the authority of section 361 of the PHS Act, which allows the promulgation and enforcement of regulations to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States, or from one state to any other state, FDA issued the Interim Rule for Human Tissue Intended for Transplantation, which was finalized on July 29, 1997 and became effective on January 26, 1998.  The objective of the rule is to impose minimal requirements for testing and screening of human tissue donors, while making all human tissue, imported and domestic, safe for transplant needs.  Thus, the regulations require tissue facilities to ensure that specified minimum required medical screening and infectious disease testing has been performed and that records documenting such screening and testing are available for inspection by FDA.  
On finding that human tissue has been collected or distributed in violation of the regulations, FDA may:
(1)	Serve upon the person who distributed the tissue a written order that the tissue be recalled and/or destroyed, as appropriate, and upon persons in possession of the tissue that the tissue shall be retained until it is recalled by the distributor, destroyed, or disposed of as agreed by FDA, or the safety of the tissue is confirmed; and/or
(2)	Take possession of and/or destroy the violate tissue.  

The rule applies to human tissue such as bone, ligaments, tendons, cartilage, skin, fascia, and corneas intended for transplantation.  It does not apply to vascularized organs such as livers, hearts, and kidneys, nor does it apply to any tissue currently being regulated by the FDA as a human drug, medical device, or biological product.  
FDA considers the appropriateness of voluntary corrective action by firms before ordering a recall.  However, FDA may choose to order a recall or destruction of tissue rather than consider voluntary compliance when there is evidence of a violation related to tissue suitability, such as if there is a significant question as to the source of the tissue, the adequacy of the testing of the donor, the adequacy of donor selection, the completeness of the records accompanying the human tissue, or failure to meet stated commitments to the FDA to gain control over or properly determine suitability of non-compliant tissue.  
FDA also addressed the regulation of human organs when the final rule on human tissue was issued.  FDA specifically excluded human organs from the rule because they are already regulated under existing federal oversight programs administered by the Health Resources Services Administration within the Department of Health and Human Services, and FDA does not believe that additional oversight by FDA is needed.  
Although a recall ordered under this authority is rare, in August 2002 FDA found it necessary to use this recall authority when it ordered CryoLife Corporation, the nation’s largest processor of donated human tissue, to recall all soft tissues processed since October because the company could not adequately assure that its soft tissue products were free of deadly bacteria and fungi.  27 people had developed serious infections, and one of them died, after receiving tissue implants processed by the company.  FDA inspected CryoLife’s operations in Georgia for two weeks in March and April and found significant violations from tissue regulations: “What they were doing did not sure tissue safety,” said Dr. Mary Malarkey, director of the division of case management in the FDA Office of Compliance and Biologics Quality.  CryoLife responded to the agency’s concerns on May 15, but FDA deemed their response inadequate and sent a warning letter to the company on June 17.  Since the company did not respond in ways that assured that their material was not bacterially contaminated, FDA decided to order the recall.  On February 18, 2003, CryoLife announced that a recent FDA inspection cleared the way for it to begin processing tissue again.  

VII.  Not Quite a Mandatory Recall: FDA Withdrawal of Approval of a New Drug Application

While FDA does not have the authority to issue a recall order for drugs, it may immediately suspend and propose to withdraw the new drug application approval for a drug found to constitute an “imminent hazard.”  As discussed previously, after the Elixir Sulfanilamide tragedy, Congress mandated the premarket approval of drugs.  The Act required applicants seeking drug approval to submit to FDA a new drug application containing, among other things, data showing the drug was safe.  The law at that time provided that a new drug application would automatically become effective within a fixed period unless the agency affirmatively refused to approve the application.  In 1962, in the wake of the thalidomide tragedy, Congress added further protections by amending the drug approval provisions to require affirmative approval of new drug applications before marketing, and that approval was to be granted on the basis of a showing that a drug product was not only safe, but also effective.  Thus, as of October 10, 1962, a new drug could not be marketed without an approved new drug application that contained both safety data and substantial evidence establishing that the drug was effective for its intended uses.  
Safety of a drug is necessarily relative.  “The decision to approve a drug for marketing, or to withdraw an earlier approval requires a weighing of the benefit to be expected from use of the product against the risk inherent in its use….”  The conclusion that there is substantial evidence of the effectiveness of a drug is based on adequate and well-controlled investigations.  
The Act gives the FDA the authority to withdraw approval of a new drug application for a number of reasons, including if the drug fails to meet either of the safety or effectiveness requirements.  The regulations are codified in 21 C.F.R. § 314.150, “Withdrawal of approval of an application or abbreviated application,” discussed in more detail below.  
Notably, the Secretary has authority to immediately suspend the approval of an application or abbreviated application for a new drug on a finding that there is an imminent hazard to the public health.  FDA will promptly notify the applicant and afford the applicant the opportunity for an expedited hearing.  The Act specifically states that the authority given to the Secretary to suspend the approval of an application shall not be delegated.  
The first time this imminent hazard authority was exercised was by Secretary Califano in 1977, in a decision to suspend the NDAs for a diabetic drug called phenformin.  The court upheld the Secretary’s decision and his criteria for determining that phenformin was an imminent hazard.  The criteria included: 
1.  The severity of the harm that could be caused by the drug during the completion of customary administrative proceedings to withdraw the drug from the general market.  
2.  The likelihood that the drug will cause such harm to users while the administrative process is being completed. 
3.  The risk to patients currently taking the drug that might be occasioned by the immediate removal of the drug from the market taking into account the availability of other therapies and the steps necessary for patients to adjust to these other therapies. 
4. The likelihood that after the customary administrative process is completed, the drug will be withdrawn from the general marketing. 
5. The availability of other approaches to protect the public health.  

Imminent hazard is also defined by the FDA in 21 C.F.R. § 2.5 as when a product or practice creates a public health situation that should be corrected immediately to prevent injury and that should not be permitted to continue while a hearing or other formal proceeding is being held.  In exercising his judgment on whether an imminent hazard exists, the Commissioner will consider the number of injuries anticipated and the nature, severity, and duration of the anticipated injury.  
The court in Califano noted that even if there is a discrepancy between the Secretary’s criteria and those set forth in 21 C.F.R. § 2.5, “the regulation was designed to guide the FDA Commissioner in making his recommendations to the Secretary with respect to the existence of an imminent hazard, and would not necessarily bind the Secretary in making his nondelegable decision to suspend.”    
Consequently, in 1979 FDA proposed to revoke § 2.5 on grounds that it is “potentially confusing to have criteria for FDA’s recommendations to the Secretary separate from the criteria for the Secretary’s decision.”  FDA later withdrew the 1979 proposed rule in 1994.  In 1996 FDA again proposed to revoke § 2.5 because it is potentially confusing and no longer necessary.  However, upon further reflection, FDA decided to retain § 2.5 because the term “imminent hazard” appears in several provisions of the Act and its implementing regulations.  
Where there is not an imminent hazard to the public health, FDA may still withdraw approval of an application or abbreviated new drug application under certain circumstances, but only after notice and opportunity for hearing.  The regulations provide that FDA “will notify the applicant, and, if appropriate, all other persons who manufacture or distribute identical, related, or similar drug products…and for a new drug afford an opportunity for a hearing on a proposal to withdraw approval of the application or abbreviated new drug application under section 505(e) of the act and under the procedure in § 314.200, if any of the following apply:” the drug is unsafe or not shown to be safe for use under the conditions of use upon the basis of which the application was approved, or there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling thereof, or the required patent information was not filed within a specified period of time, or the application contains any untrue statement of material fact.  
Additionally, FDA “may notify the applicant, and, if appropriate, all other persons who manufacture or distribute identical, related, or similar drug products…and for a new drug afford an opportunity for a hearing on a proposal to withdraw approval of the application or abbreviated new drug application under section 505(e) of the act and under the procedure in § 314.200, if the agency finds:” that the applicant has failed to maintain the required records, make the required reports, or provide access to those records, or that the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the drug are inadequate to ensure and preserve its identity, strength, quality, and purity, or that the labeling of the drug is false or misleading…  
It is interesting to note in the above regulations the difference between what the FDA will notify the applicant of and what the FDA may notify the applicant of.  The agency has always valued its discretion in handling both procedural and substantive aspects of enforcement.  
While the FDA does not have statutory authority to order the recall of drugs, withdrawal of a drug application is a viable alternative for getting unsafe or ineffective drugs off the market.  FDA can also, of course, voluntarily request that a company recall the suspect drug in conjunction with the withdrawal of the drug application.  In fact, the regulations state that:
FDA may notify an applicant that it believes a potential problem associated with a drug is sufficiently serious that the drug should be removed from the market and may ask the applicant to waive the opportunity for hearing otherwise provided for under this section, to permit FDA to withdraw approval of the application or abbreviated application for the product, and to remove voluntarily the product from the market. If the applicant agrees, the agency will not make a finding under paragraph (b) of this section, but will withdraw approval of the application or abbreviated application in a notice published in the Federal Register that contains a brief summary of the agency’s and the applicant’s views of the reasons for withdrawal.  

FDA requires anyone having an approved drug application to make prompt reports of adverse drug experiences, and periodic reports of all information relating to a drug’s safety and effectiveness.  Responding to comments objecting to deleting the word “significant” from the phrase “any significant failure of expected pharmacological action” in the definition of “adverse drug experience,” FDA said it had deleted the word “significant” because it intended to require reports of any drug failure, as the agency considers all such failures to be significant.  
Similarly, FDA requires manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application to establish and maintain records and make reports to FDA of all serious, unexpected adverse drug experiences associated with the use of their drug products.  These reports aid the agency in determining whether it should take regulatory action.  

VIII.  Expanding FDA’s Power to Order Recalls: Pros and Cons

Attempts to give FDA general mandatory recall authority have all failed.  FDA attempted to broaden its drug regulatory power in the Drug Regulation Reform Act of 1978.  The bill proposed to give the FDA the authority to order recalls and repurchases of drugs and the power to seek civil penalties.  Some feared that the administration of these powers would result in arbitrariness and inflexibility, to the extreme economic harm of drug companies.  The bill eventually died in committee.  During three consecutive sessions of Congress, Senator Tom Harkin (D-IA), ranking Democrat on the Senate Agriculture, Nutrition, and Forestry Committee, introduced a bill that would give USDA mandatory recall authority: in the 105th Congress, the Food Safety Enforcement Enhancement Act of 1997, introduced on October 7, 1997; in the 106th Congress, the Safe and Fair Enforcement and Recall for Meat and Poultry Act, introduced on January 19, 1999; and in the 107th Congress, the Safe and Fair Enforcement and Recall for Meat, Poultry, and Food Act, introduced on July 26, 2002.  In this third bill, Senator Harkin included mandatory recall authority for the FDA as well.  Hearings were held on the Food Safety Enforcement Enhancement Act of 1997, but no action was taken after the hearings.  Each of the bills died in committee.  
	There has been much oral and written debate on the issue of mandatory recall authority.  In December 2002, the Food Safety and Inspection Service of USDA held a public meeting to discuss ways to improve the recall process.  Because USDA, like FDA, does not have authority to order a recall, mandatory recall authority was discussed in some length.  A lawyer for the Senate Agriculture Committee, speaking in favor of Senator Harkin’s SAFER Meat, Poultry, and Food Act, noted that most companies would probably still voluntarily conduct recalls in order to maintain more control over the process.  Mandatory recall authority would be useful when a company refuses or wants to delay a voluntary recall request.  
Many supporters of mandatory recall authority say that although voluntary recall has generally worked well in the past, future needs are unknown.  And there do exist situations where companies have delayed or refused to initiate voluntary recalls.  From their recollections, FDA officials noted that they can remember nine cases out of over 3,000 recalls where a company delayed initiating or refused to initiate a recall following an informal request by the agency.  In two of the nine cases, the companies initially resisted beginning a recall, but then reconsidered without further urging from FDA.  In five of the nine cases, the companies agreed to recall their products after FDA made a formal written recall request, and, in two of those five cases, issued a press release.  In one case, the importer recalled the product—smoked salmon contaminated with listeria—but the sole distributor refused to recall the salmon or provide FDA with further distribution information.  Although FDA issued a press release warning consumers not to eat the salmon, it did not pursue seizure because it did not know where the salmon had been distributed.  
The final case concerned a company that made “Nature’s Nutrition Formula One,” a supplement containing ephedra and caffeine.  After the company’s refusal of FDA’s formal request to recall its supplements, FDA issued a public warning: “Because the company to date has failed to recall its potentially dangerous products, FDA is issuing today’s warning as a matter of public health protection.”  FDA said that seizure was not a viable option since it was unlikely that FDA would find sufficient quantities of product to seize.  However, FDA eventually learned that the manufacturer of the Formula One had concealed the actual ingredients of the product and misled FDA investigators.  The product was labeled as “all natural” but contained synthetic ephedrine hydrochloride and caffeine anhydrous.  As a result, the government initiated a criminal prosecution against the company and its president, and on July 7, 2000, a federal judge sentenced the president to 21 months in jail and fined him and the corporation $4.7 million.  In spite of all this, since products with ephedra were deemed adulterated by FDA’s February 2004 regulation, the company appears to still be in business with a slightly modified name, proudly touting its ephedra-free reformulated product as “Natural Nutrition’s ‘The # 1 Formula.’”  While a public warning can be effective, and a criminal prosecution just, they do not remove the product from the market.  Mandatory recall authority would provide insurance against the occasional noncooperative company.  
Most supporters of mandatory recall authority believe that the authority should supplement, but not overhaul, the current voluntary system: “if a mandatory recall system can be devised that still allows and encourages voluntary recalls by food companies, then the implicit threat that now compels voluntary recalls will continue to compel companies to do so. The difference will be that a mandatory recall system will render the implicit threat a real threat.”  Senator Harkin’s bills provide that before ordering a recall, FDA and USDA would first give the company an opportunity to voluntarily recall its product.  
Many consumer groups are in favor of mandatory recall authority, including Consumer Reports, one of the country’s most notable consumer watchdog organizations.  Supporting Senator Harkin’s legislation, Mark Silbergeld, then co-director of the Consumers Union Washington D.C. office, which is the nonprofit publisher of Consumer Reports, said “The power to recall tainted meat and poultry and to seek civil fines is essential.  All USDA can do now is shut down plants and seek criminal penalties, which is like having to seek the death penalty for every violation of the law.  The agency won’t do that very often, so we need penalties more suited to less extreme violations.”  While he neglected to mention the agency’s powers of seizure, detention, and injunction—far less drastic and more common than the death penalties of food enforcement—the sentiment that recall is often the most appropriate method of enforcement is shared by many.   
Supporters also say that mandatory notification and mandatory recall should decrease delay in the recall process because FDA would be notified of potentially violative products earlier than they are notified currently.  
Some people justify mandatory recall authority by saying that sometimes only a small percentage of the recalled product is recovered.  But critics note that there is no evidence that indicates that the amount of product recovered would have been different had the recall been mandatory instead of voluntary.  There might be a low recovery rate for a recalled food, for example, if the product had been in the market for some time and was perishable.  The food might have been disposed of before the recall was even initiated, or after the recall but without notification to the company.  Additionally, the CDC collected data for one particular food recall that showed that over one-fourth of the people who purchased the food, received notice of the recall, and understood that the recall was related to the food in their homes, ate the food anyway.  One can imagine this disregard for a recall action in a typical Class I food allergen recall, for example, when a particular consumer might appreciate that the package of Pop-Tarts contains undeclared egg, but ignores the recall order because she is not herself allergic to egg. 
	Those against mandatory recall legislation say that there is no demonstrated need for it.  As a practical matter, “any company that is asked to initiate a recall has little incentive to refuse this request, and significant incentive to cooperate promptly.”  Publicity, detention, seizure authority, injunction, and criminal prosecution are all powerful tools both the FDA and USDA possess, and these tools are part of why companies have had such an excellent record of cooperation with the agencies when recalls are warranted.  Additionally, it is in a company’s best interest to remove a suspect product from the market to reduce the chance that it will be exposed to tort liabilities.  Other business imperatives, such as the value of a brand name, also induce a company to comply with agency recall requests.  
Instituting a mandatory recall system would risk stifling the cooperation between government and industry, creating an adversarial relationship between the agency and the company, which would make the recall process slower.  However, GAO notes that none of the agencies they talked to that have mandatory recall authority—such as the Canadian Food Inspection Agency or the Consumer Product Safety Commission—mentioned that their mandatory recall authority slowed the recall process.  They view it as a useful tool when companies are slow or uncooperative and consumers are at risk.  
Under a mandatory recall system, a dispute between the company and the agency may be removed from the controlled regulatory regime and dragged into the courts.  Consequently, agency officials might be reluctant to order a recall unless they are absolutely certain that they can win a court challenge on the appropriateness of the recall order.  Additionally, the agency might be exposed to liability if the responsibility for recall rests with it.  
“FDA has never vigorously sought legislation giving it power to order recalls administratively, fearing that such authority would almost certainly be encumbered by procedural requirements that would effectively frustrate its exercise.”  This is the most persuasive rationale for maintaining the current voluntary recall system.  For example, if FDA had mandatory recall authority, then there might also be a requirement for the agency to provide an opportunity for hearing before the issuance of each recall order.  This is the protocol the agency must follow if it orders a recall of a medical device under the authority provided by section 518(e) of the Act.  Although the agency may refuse a request for hearing if it determines that no genuine and substantial issue of fact is raised by the material submitted in the request, this determination, and possible challenges that may be allowed to the determination, could be an extreme drain on FDA resources and a hindrance to the timely progress of a recall.  Senator Harkin’s bill proposed to allow USDA and FDA to issue a cease distribution and notification order, then hold a hearing within two business days to provide the person subject to the order an opportunity to explain “any reasons why the article of food that is the subject of the order should not be recalled.”  
It is important to note that not every mandatory recall requires a pre-order hearing—for example, upon a finding that an infant formula presents a risk to human health, FDA can order its recall without a hearing.  However, infant formula is seen as a special class of foods deserving special protections.  There is very little chance that the same discretion granted to FDA with regard to mandatory recalls of infant formula will apply to all other FDA-regulated products.  
Perhaps supporters of mandatory recall authority might say that FDA will not be burdened with hearings because most companies will still conduct recalls voluntarily, and therefore not trigger the hearing requirement, or otherwise choose to waive the hearing.  However, it is difficult to predict how companies might react, knowing that only a simple refusal to recall a product would result in a host of administrative obstacles for the FDA.  Companies might be inclined to gamble with agency, refusing to conduct a voluntary recall in the hope that FDA’s desire to effect a particular recall will be outweighed by the administrative hurdles involved and the agency’s lack of resources.  
Yet as burdensome as a general pre-order hearing requirement would be, there would be due process concerns if only post-order hearings were available.  An opportunity for hearing after the recall is underway or complete does not provide meaningful relief to a company if the recall was ordered in error.  Only if a recall system is mandatory must due process requirements be met.  An agency suggesting to a company to recall a product does not invoke due process requirements.  
More likely than not, general mandatory recall provisions will find themselves entangled in procedural and administrative requirements, and tired, overworked FDA officials will be tangled up with them.  Furthermore, any delay in the implementation and completion of a recall presents an additional risk to the public, as potentially hazardous products remain on the market for an even longer period of time. 

IX.  Problems Underlying the Recalls: Spotlight on Food

	There are many reasons that recalls are needed, as the FDA Enforcement Reports illustrate.  Food may have unidentified allergens, environmental contaminants, or bacterial contaminants.  Drugs may be mislabeled, contaminated, manufactured in non-sterile conditions, or otherwise impure.  Medical devices may have problems with product design or production controls.  Recalls are essential to protect the public from products on the market that are harmful to health.  
	Because food is such an important part of daily life, it seems worthwhile to focus on foodborne illnesses for a brief moment.  Foodborne illness, naturally, results from eating contaminated foods.  The CDC estimates that 76 million people get sick, more than 300,000 people are hospitalized, and 5,000 people die from foodborne illnesses in the United States each year.  According to available data and staff recollections, FDA recalled 49 foods from 1997 to 1999 and USDA recalled 12 foods from 1988 to 1999 that were associated with outbreaks of foodborne illnesses.  These 61 recalls were all caused by five strains of bacteria and two viruses, with the primary culprits being the Norwalk or Norwalk-like virus, salmonella, and E. coli.  26 of the recalls were due to the consumption of contaminated raw oysters, 9 recalls were due to contaminated sprouts or seeds, and 6 recalls were attributed to frozen strawberries or products with the strawberries.  
USDA and FDA were not able to determine how the foods became contaminated.  This is unfortunately quite common.  In the Borden Starlac case, FDA investigators inspected “the Dixon plant almost inch by inch, and its personnel almost person by person to discover where the salmonella came from.  The germs are ubiquitous and the source may be from animal, bird, water or human.”  Some people advocate regular, early, ongoing testing programs to ensure that companies are focused on finding and fixing contaminated or violative products before they enter the market and injure consumers.  Such testing programs can be particularly effective with well-known hazards that can be anticipated, such as E-coli or salmonella.  It was this kind of early testing that identified salmonella in the samples of Starlac milk, allowing the product to be taken off the market before it made anyone ill.  One of a company’s goals should be to prevent recalls through a thorough and objective review of its manufacturing and quality control procedures.  
	As important as it is to ensure the safety of our food, it is also important to remember that there is risk inherent in everything.  Former FDA Chief Counsel Peter Barton Hutt formulates three general rules for food safety evaluation.  First, “there is no such thing as absolute safety.  All food components are capable of producing harm in some people under some circumstances.  Some risk must be tolerated by the public if we are to have any food at all.”  Second, safety should be viewed relative to competing alternatives – if there are several fungible food components that satisfy a particular need, eliminate any which pose a significantly greater risk.  Third, there is a need for a special analysis for those food components which do pose safety problems but do not have a fungible alternative.  In order to take into account the wishes of the public and protect individual freedom of choice, the analysis should consider the appropriateness of regulatory control other than an outright ban of the food.  Examples of such foods are alcoholic beverages, charcoal-broiled steak, snack foods, fish, and artificially sweetened products—“recreational foods” that give us pleasure rather than demonstrated medical or nutritional value.  It is important to consider whether the risk of the food can be clearly conveyed and appreciated by the public and whether a consumer can make a conscious decision to accept that risk.  Because of proper labeling, when I pick up a can of Fat Free Pringles made with olestra, I understand that Vitamin K absorption will be inhibited and certain gastrointestinal problems may very well ensue, but I make an informed choice that the 70 calories per serving is worth it for me, occasionally.  It is also important to take into account such things as whether the risk exists only for people who eat large quantities, or for everyone who consumes the food, and whether the risk involves potential harm to those needing special protection.  Part of the rationale for mandatory recalls of infant formula is to protect an extremely vulnerable population.  Often infant formula is the only source of nutrition for infants, and inadequate nutrition in infancy can result in serious and irreversible adverse effects.  There is, therefore, greater regulation and control over that product.  

X.  Conclusion

FDA plays an important role in society by assessing the net benefits and risks of the products it regulates.  Unlike companies, which have profits, shareholders, and boards of directors to consider, FDA acts only for the public well-being.  Therefore, when it determines that a recall is necessary, a company has a duty to comply.  No one else can do a recall as quickly as the company, which has all the records of shipment, product code information, relationships with the trade in the chain of distribution, and often a sales force in the field.  Mandatory recall or not, a company should want to comply to make sure it is not endangering the public.  That being said, sometimes a recall is a serious financial burden on a company.  Some food companies carry recall insurance to cover lost revenues and retrieval costs, though many companies consider the recall insurance too expensive to purchase.  We have seen companies such as Bon Vivant declare bankruptcy after its entire stock of canned soups were recalled and seized due to contamination with the botulin toxin.  Less drastic, though still serious, sometimes companies shift the costs of a recall by downsizing, as was the case with CryoLife, when it laid off 105 workers, mostly tissue-processing technicians, after FDA ordered the recall of its human tissue products.    
However, there are a number of things a company can do to minimize the disruption a recall can have on its business.  A company should make sure it has a contingency plan in effect for use in initiating and carrying out a recall.  To learn from the Bon Vivant recall, a company needs to ensure it has the controls and resources necessary to successfully carry out a recall.  It should make sure its products are coded in a way that allows effective identification of a recalled lot.  It needs to keep adequate distribution records of its production lots and product movements in order to trace the products quickly and effectively.  A company also needs to make sure it has the financial and employee resources necessary to accommodate a recall program.  In addition to minimizing the impact of a recall on the company, these actions also serve to minimize the negative effect of the violative product on the public health.  
As for the mandatory recall power, many supporters recommend that Congress enact legislation that would give FDA mandatory recall authority and authority to require that companies alert the agency when they discover they have distributed potentially unsafe food.  It would be important for Congress to remember that these authorities can be enacted separately—for example, if Congress is hesitant, due to potential due process or administrative concerns, to pass catch-all bills such as those Senator Harkin has repeatedly proposed, it can still enact a more limited law providing only for mandatory reporting upon discovery of a violative or unsafe product.  Or Congress can authorize the FDA to prescribe record-keeping requirements for all companies to ensure that the agency has ready access to more thorough product distribution information, much as the Bioterrorism Act recently established for food.  Whatever the law, FDA has proven time and again that it is up to the challenges of the day, always finding ways to protect the public health—whether that means negotiating a voluntary recall with a multi-million dollar drug company, or scouring the country and breaking down doors to retrieve a deadly poison.  

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