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\tx204\adjustright \sbasedon0 \snext35 p20;}{\s36\qj\fi732\sl453\slmult0\nowidctlpar\tx731\tx1048\adjustright \sbasedon0 \snext36 p21;}}{\info{\title Michael Sandier}{\author Faculty Library}{\operator Faculty Library}{\creatim\yr2001\mo2\dy23\hr16\min26}
{\revtim\yr2001\mo2\dy23\hr16\min26}{\version2}{\edmins0}{\nofpages1}{\nofwords4950}{\nofchars28217}{\*\company Harvard Law School Library}{\nofcharsws34652}{\vern113}}\margl1428\margr1435\margt1468\margb1474 
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\nowidctlpar\tx204\adjustright {\f1\fs28 Michael Sandier
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par }\pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 HU# 30455983
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par 
\par }\pard\plain \s17\qc\nowidctlpar\tx204\adjustright {\b\f1\fs28 The Regulation of Toothpaste
\par }\pard\plain \qj\nowidctlpar\tx204\adjustright {\b\f1\fs28 
\par 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\b\f1\fs28 Food }{\f1\fs28 is the }{\b\f1\fs28 very }{\f1\fs28 
sustenance of life for humans. Perhaps no body structures are more crucial to human consumption of food than our teeth. The teeth serve to break up larger pieces of food into smaller, more digestible bits that our bodies can use. Teeth are always subject 
t
o decay from the various food particles that are constantly brushed against them, occasionally left undetected there for several hours. Humankind invented toothpaste for a variety of reasons, the most important of which is the prevention of this tooth dec
a
y. Others include the freshening of breath, and the whitening or strengthening of the teeth. Usually, we, the buying public, do not see this product until it is in its familiar plastic tubing at the supermarket, complete with an easy-to-read (usually) lab
e
l and brand name conveniently on the front. However, before their product reaches the shelves, manufacturers of toothpaste in this country are regulated by the Food and Drug Administration with various practices designed to protect the public. These pract
i
ces include official FDA standards on toothpaste safety and effectiveness, as well as regulation of how much and which kind of ingredients are permitted in the formula. There are also strict standards involving the labeling of the toothpaste, as establish
ed in the FDA's final monograph for anticaries drug products. Lastly, a brief look at toothpaste regulation in other countries will serve to show the relative severity of regulation practiced by the FDA.
\par }{\fs20 \page }{\b\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s17\qc\nowidctlpar\tx340\adjustright {\b\f1\fs28 Classification of Toothpaste Under the 1938 Act
\par }\pard\plain \qj\nowidctlpar\tx340\adjustright {\b\f1\fs28 
\par 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 Since its enactment in 1938, administration of the }{\b\f1\fs28 Federal Food Drug and Cosmetic Act }{\f1\fs28 
has fallen on the Food and Drug Administration (FDA). The 1938 Act brought cosmetics and medical devices under the statute, in addition to the foods and dr
ugs already within its scope before 1938. Under the Act, foods are regulated differently than cosmetics, which are in turn dealt with differently than drugs. The placing of toothpaste into one of these three categories is more complex than it first may se
em. Section 321 of the Act defines "food" as (1) articles used for food or drink in man or other animals, (2) chewing gum, and (3) articles used for components of any such article.}{\f1\fs28\super 1 }{\f1\fs28 
Clearly, toothpaste does not fall into this category. Humans and other anim
als do not eat this product, nor do they intentionally consume any of it at all. The next category in the Act is "drugs," which are defined briefly as (A) any article recognized in any of the official national drug publications or a supplement thereof, an
d (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, or (C) articles (other than food) intended to affect the structure or any function of the body.}{\f1\fs28\super 2 }{\f1\fs28 
Subpart (B) of this definition 
makes a good case for the inclusion of toothpaste, as one of the main purposes of toothpaste is the prevention of tooth decay, known as caries. Under the statute, toothpaste is likely ruled out of the "medical device" category because it achieves its prim
ary intended purposes through chemical action within the body.}{\f1\fs28\super 3 }{\f1\fs28 Lastly, there is the
\par }\pard\plain \s19\sl-453\slmult0\nowidctlpar\tqdec\tx1207\tx1383\tx2403\adjustright {\f1\fs28 \tab }{\f6 21\tab U.S.C.\tab \'a7321(f) (1938)\line \tab 21\tab U.s.c.\tab \'a7321(g) (1)\line \tab 21\tab U.s.c.\tab \'a7321(h)
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 cosmetic" category, which also could include toothpaste. These are defined as articles
 intended to be rubbed, poured, sprinkled, or sprayed on, introduced to, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. Again, toothpaste could fall under this category since it cou
ld be said that its purposes are cleansing and beautifying the teeth.
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
The FDA has spoken in the Federal Register as to how the distinction between a drug and a cosmetic is to be determined. The FDA has stated that "the intended use of a product is the prim
ary determining factor as to whether a product is a drug, a cosmetic, or both."}{\f1\fs28\super 4 }{\f1\fs28 
This intended use may be inferred from the product's labeling or advertising, as well as from any other relevant factor, including the presence of particular ingredients.}{\f1\fs28\super 5}{\f1\fs28  The
 presence of a known therapeutic ingredient can cause a product to be regulated as a drug, even in the absence of drug claims. Along these lines, the FDA has decided that all toothpastes or other dentiftices which contain fluoride will indeed be regulated
 as drugs, regardless of whether or not any drug claims have been made.}{\f1\fs28\super 6 }{\f1\fs28 
The Agency reasons that fluoride is widely accepted as an anti-cavity agent by the dental products industry and consumers, and because fluoride affects the structure of the tooth.}{\f1\fs28\super 7 }{\f1\fs28 The
 Agency has also stated that "intended use" can be demonstrated by evidence that (1) drug-like effects in a large proportion of users are foreseeable by the reasonable manufacturer, (2) consumers use the product predominantly for its significant pharmacol
ogical effects, or (3)
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par }\pard\plain \s20\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\tx992\adjustright {\f6 ~\tab 59 Fed. Reg. 5226, 5227 (1994)
\par }\pard\plain \qj\sl-294\slmult0\nowidctlpar\tx731\tx992\adjustright {\f6 
\par }\pard\plain \s20\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\tx992\adjustright {\f1\fs12 ~\tab ~ }{\f6\ul National Nutritional Foods Association }{\i\f1\fs14\ul V. }{\f6\ul Mathews}{\f6 , 557 F.2d 325, 334 (2d Cir. 1977)
\par }\pard\plain \qj\sl-294\slmult0\nowidctlpar\tx731\tx992\adjustright {\f6 
\par }\pard\plain \s21\qj\li992\nowidctlpar\tx992\adjustright {\f6 59 Fed. Reg. 6084, 6088 (1994)
\par }\pard\plain \qj\nowidctlpar\tx992\adjustright {\f6 
\par }\pard\plain \s21\qj\li992\nowidctlpar\tx992\adjustright {\f6 60 Fed. Reg. 41453 (1995)
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 manufacturers know that the product will be used for these drug-like effects.}{\f1\fs28\super 8 }{
\f1\fs28 This drug classification reflects a general decision on FDA's part that toothpastes are indeed used primarily for the prevention of disease; in truth, such products are labeled 
as "anticaries agents" in all versions of the FDA's monograph for such products, and nearly all tubes of toothpaste contain somewhere on the label the message that the product fights cavities and/or prevents tooth decay.
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 This explanation would seem to lea
ve open the possibility that a toothpaste could be regulated at least partially as a cosmetic if its main claims were for the beautification of the teeth, and not the prevention of caries. The FDA has ruled that if a product is intended for use as both a 
drug and as a cosmetic, it must comply with all of the specifications found for the drug within the FDA final monograph, plus it must bear the applicable labeling for cosmetic use in conformity with 21 U.S.C. \'a7
362.~ However, achieving a "cosmetic" status fo
r any type of toothpaste or dentifrice would be a difficult task, since most such products do contain some amount of fluoride, a proven cavity fighter, and would thus automatically be regulated as a drug. The FDA has also explained that, in the case of to
o
thpastes, the cosmetic function of attractive teeth is accompanied by the drug mechanism of preventing cavities, and it has thus prohibited "cosmetic" status on these grounds. One can only surmise that it would still be possible to have a toothpaste regul
a
ted as a cosmetic, but this would not be a toothpaste in the traditional sense. A cosmetic toothpaste would likely have to contain no known therapeutic or drug-like ingredients, and be marketed, labelled, intended, and primarily used as a cosmetic. An exa
mple might be a toothpaste offered
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par }\pard\plain \s20\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\tx992\adjustright {\f6 ~\tab 58 Fed. Reg. at 47611 (1993)
\par }\pard\plain \qj\sl-294\slmult0\nowidctlpar\tx731\tx992\adjustright {\f6 
\par }\pard\plain \s20\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\tx992\adjustright {\f6 ~\tab 59 Fed. Reg. 5226, 5227 (1994)
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
solely to smokers to whiten their stained teeth, with no anticaries indications. An additional comment on the label specifying that the pr
oduct is not an anti-cavity agent and that another anticaries toothpaste should be used in conjunction with this product could only help the cause. It is unclear how such actions would fare in court, since the ingredients approach to classification has no
t been tested adequately nor applied consistently by courts or by the FDA.}{\f1\fs28\super 10}{\f1\fs28 
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par 
\par }\pard\plain \s17\qc\nowidctlpar\tx204\adjustright {\b\f1\fs28 Are Certain Toothpastes "New Drugs?"
\par }\pard\plain \qj\nowidctlpar\tx204\adjustright {\b\f1\fs28 
\par 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 In order to better protect the public from drugs that are unsafe or ineffective, the FDA strictly limits the drugs that may be entered into
 interstate commerce without first being reviewed and approved by the Agency. This FDA power, however, does not extend over all drugs; drugs that are not defined as "new drugs" under the statute may be introduced and marketed without premarket Agency revi
e
w or approval. However, in the case of "new drugs", a New Drug Application (NDA) must be submitted to and approved by the FDA before the product may be legally marketed. The FDA, in determining the status of an NDA, must be satisfied that the new product 
i
s both safe and effective before it will approve the application. The Act defines a "new drug" as "Any drug.. .the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to ev
aluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed.., in the labeling thereof...."" Under
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par }\pard\plain \s22\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 10 }{\f6 51 Food & Drug L.J. 243, 255 (1996)
\par }\pard\plain \qj\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s22\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 " }{\f6 21 U.S.C. \'a7}{\f6\super 32}{\f6 l(p) (1938)
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
these guidelines, a toothpaste which merely uses the same ingredients in the same combination as another, previously approved toothpaste formula would not be classified as a "new drug" under the statute. Thus, manufacturers of such a product would avoid h
a
ving to submit an NDA and could avoid FDA regulation as a "new drug" entirely. However, since toothpastes have become widely used, manufacturers have constantly sought new ingredients, and new combinations thereof, in an effort to further differentiate th
e
ir product from the myriad others on the market and to attract the consumer to their brand because of its particular ingredients and abilities. This has caused some potential problems in the FDA conferring a much-unwanted "new drug" status upon certain to
othpastes. In }{\f1\fs28\ul U.S. v. Articles of Drug...}{\f1\fs28  }{\f1\fs28\ul Promise Toothpaste}{\f1\fs28\ul\super 12}{\f1\fs28 , the court affirmed that certain toothpastes
 are indeed "new drugs" under the 1938 Act. The court explained that even if the component parts of a new drug are generally recognized as safe or effective, the combination of those parts may still be unsafe or ineffective.}{\f1\fs28\super 13 }{\f1\fs28 
Thus, quantities of toothpaste containing this new combination of active ingredients and introduced into interstate commerce without an approved NDA were subject to forfeiture.}{\f1\fs28\super 14 }{\f1\fs28 
An OTC drug be recognized as safe and effective after combining two or more safe and effective active ingr
edients only if the new drug meets the following three conditions: (1) each active ingredient makes a contribution to the claimed effect(s), (2) combining of the active ingredients does not decrease the safety or effectiveness of any of the individual act
ive ingredients, and (3) the combination, when used under adequate directions for use and
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par }\pard\plain \s23\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 12 }{\f6 826 F.2d 564 (7th Cir. 1987)
\par }\pard\plain \qj\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s24\qj\li737\nowidctlpar\tx737\adjustright {\f1\fs14 13 }{\f1\fs26 .I4~ }{\f6 at 3
\par }\pard\plain \qj\nowidctlpar\tx737\adjustright {\f6 
\par }\pard\plain \s22\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 14 }{\f6 j~ at 5
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 warning against unsafe use, provides rational concurrent therapy for a significant proport
ion of the target population.}{\f1\fs28\super 15 }{\f1\fs28 In the }{\f1\fs28\ul Promise Toothpaste}{\f1\fs28 
 case, the court, using these criteria, ruled that Promise's combination of a single anticaries ingredient and another active ingredient is a "new drug" subject to the NDA requirements of the 1938 Act. According to the }{\f1\fs28\ul Promise}{\f1\fs28  }{
\f1\fs28\ul Toothpaste}{\f1\fs28  case and the regulation, for combination toothpaste products, the manufacturer must likely get a new NDA approved for the product. Since this process is time-consuming and costly, and could potentially lead to denial 
of an NDA anyway, most manufacturers would like to avoid this step. In order to avoid this classification as a "new drug" under the statute, the manufacturer of a combination toothpaste must show that each ingredient contributes to the claimed effects, an
d that the combination does not make any of the individual components any less safe or effective.}{\f1\fs28\super 16}{\f1\fs28 
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par 
\par }\pard\plain \s17\qc\nowidctlpar\tx204\adjustright {\b\f1\fs28 Safety Regulations for Toothpaste
\par }\pard\plain \qj\nowidctlpar\tx204\adjustright {\b\f1\fs28 
\par 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
In the Federal Register of October 6,1995, the FDA established its final monograph for OTC anti-cavity drug products. This final monograph includes the conditions under which the products covered by the monograph will be considered safe and effective. In 
e
nsuring the safety of toothpaste, the FDA has established a number of regulations, relating to the required testing procedures before the product may be marketed, the size and type of packaging for the product, and the necessary ingredients and warnings o
n the
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par 
\par }\pard\plain \s23\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 15 }{\f6 21 C.F.R. \'a7330.10(a) (4) (iv)
\par }\pard\plain \qj\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s23\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f1\fs12 lb }{\f1\fs30 ~ee }{\f6\ul U.S. v. Articles of Drug.. .Promise Toothpaste}{\f6 , 826 F.2d 564; ~ }{\f6\ul U.S. v. Seven Cardboard Cases.. .100}{\f6 
\par }\pard\plain \s25\qj\nowidctlpar\tx204\adjustright {\f6\ul Capsules.. .With Codeine}{\f6 , 716 F.Supp. 1221, 1223
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 label.
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par }\pard\plain \s26\qj\fi516\sl-566\slmult0\nowidctlpar\tx515\adjustright {\f1\fs28 The final monograph establishes 
two tests, one of which must me met by any toothpaste product before it is considered safe to be on the market for humans. Each product must satisfy either the enamel solubility reduction test or the fluoride enamel uptake test. Either of the two tests is
 sufficient to satisfy the safety requirement.}{\f1\fs28\super 17 }{\f1\fs28 
The procedures for these tests are readily available at the FDA offices in Maryland. As part of these biological tests, the United States Pharmacopeia fluoride dentifrice reference standards and reference sta
ndard stability profiles (total fluoride, available fluoride ion, pH, and specific gravity) must be used, and these too are available at the FDA offices.}{\f1\fs28\super 18}{\f1\fs28 
 Additionally, alternative tests may be used, provided that the manufacturer petitions the FDA with the vital data of these proposed tests and makes all required disclosures.}{\f1\fs28\super 19}{\f1\fs28 
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx515\adjustright {\f1\fs28 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
In terms of toothpaste packaging, the FDA is concerned with the toxicity of fluoride, an active ingredient in almost all toothpastes due to its proven cavity-fighting power. Thus,
 the Agency has placed a package size limitation on all dentifrice (toothpaste and tooth powder) products. According to the final monograph, such products may not contain more than 276 milligrams of total fluorine per package.}{\f1\fs28\super 20 }{
\f1\fs28 This requirement is what ke
eps toothpaste tubes at their relatively small size. Additionally, the FDA also thought it important to avoid exposure of water and other moisture to certain toothpastes. Thus, all fluoride powdered toothpastes must be packaged in a "tight container." Thi
s is defined in
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par }\pard\plain \s22\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 '~ }{\f6 60 Fed. Reg. 52474(1995), as codified in 21 C.F.R. \'a7355.70 (a) (1995)
\par }\pard\plain \qj\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s23\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 18 }{\f6 \'a7355.70(b)
\par }\pard\plain \qj\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s23\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 19 }{\f6 \'a7355.70(c)
\par }\pard\plain \qj\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s23\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 20 }{\f6 60 Fed. Reg. 52474(1995), 21 C.F.R. \'a7355.20(a) (1) (1995)
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
the section as "a container that protects the contents from contamination by extraneous liquids, solids, or vapors, from loss of the article, and from efflorescence, deliquescence, or evaporation" under ordinary conditions of handling, shipment, storage, 
and distribution. Such a container must also be capable of tight closure.}{\f1\fs28\super 21 }{\f1\fs28 The exception is that package size limitations do not apply to anticaries drug products marketed for professional office use only.}{\f1\fs28\super 22 }
{\f1\fs28 \'a7355.60(b) provides that the labeling of products marketed to health professionals in package sizes larger than those allowed in \'a7
355.20 must contain on the label "For Professional Use Only" and "This product is not intended for home or unsupervised consumer use." Note also that dentifrices, along with 
dermatologics and insulin, are the only OTC drugs not subject to the FDA's tamper-resistant packaging requirement.}{\f1\fs28\super 23}{\f1\fs28 
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 The final monograph for anticaries drug products also requires a number of disclosures to be prominently on the label of the product to en
sure public safety. These requirements will be discussed in a later section, under "Labeling."
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par 
\par }\pard\plain \s17\qc\nowidctlpar\tx340\adjustright {\b\f1\fs28 Effectiveness Regulations for Toothpaste
\par }\pard\plain \qj\nowidctlpar\tx340\adjustright {\b\f1\fs28 
\par 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 The FDA also dealt with ensuring the effectiveness of toothpaste in its final monograph for anticaries drug products
. Effectiveness is defined as a reasonable expectation that, when used under adequate directions and warnings, a significant proportion of the target
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par }\pard\plain \s22\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 21 }{\f6 \'a7355.20(b)
\par }\pard\plain \qj\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s23\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 22 }{\f6 \'a7355.20 (a) (3)
\par }\pard\plain \qj\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s23\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\adjustright {\i\f1\fs14 23 }{\f6 47 Fed. Reg. 50442(1982)
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 population will show significant relief of the type claimed.}{\f1\fs28\super 24 }{\f1\fs28 
Much as with the safety requirements, all toothpaste products must meet the animal caries reduction test before being marketed to humans.}{\f1\fs28\super 25 }{\f1\fs28 In other words, the ingredients in every tube of toot
hpaste we see must first have been proven at least to reduce tooth decay in animals. This was a new requirement in the final monograph, and as a result, all products are expected to comply with this requirement by June 30, }{\b\f1\fs20 1997.26 }{\f1\fs28 
As with the required safety tests, \'a7
355.70(c) allows alternative effectiveness tests with the proper petition and approval. Additionally, the OTC Panel concluded in 1980 that if certain analytic and biologic tests are performed, and acceptable results are achieved, then clinical t
esting is not required because extensive clinical testing has previously been performed on the effectiveness of toothpaste products. The acceptable results are those obtained from other toothpastes that have already been proven to be clinically effective.
}{\f1\fs28\super 27 }{\f1\fs28 Note that if a toothpaste contains a combination of ingredients, as discussed above, then new clinical testing will be required to confirm the safety and effectiveness of this combination drug.
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par 
\par }\pard\plain \s17\qc\nowidctlpar\tx204\adjustright {\b\f1\fs28 Labeling of Toothpaste
\par }\pard\plain \qj\nowidctlpar\tx204\adjustright {\b\f1\fs28 
\par 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 There are several regulations in the final monograph for anticaries drugs dealing with
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par 
\par }\pard\plain \s22\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 24 }{\f6\ul U.S. v. Articles of Drug.. .Promise Toothpaste}{\f6 , 826 F.2d
\par }\pard\plain \s27\qj\nowidctlpar\tx204\adjustright {\f6 564 (7th Cir. 1987)
\par }\pard\plain \qj\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s23\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 25 }{\f6 60 Fed. Reg. 52474 (1995), 21 C.F.R. \'a7355.70(a) (1995)
\par }\pard\plain \qj\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s22\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\adjustright {\i\f1\fs14 26 }{\f6 61 Fed. Reg. 65944, 65945 (1996)
\par }\pard\plain \qj\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s23\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 27 }{\f6 45 Fed. Reg. 20677 (1980)
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
the labeling of the products, some of which apply only to toothpastes, and others which apply more generally to all anticavity drug products (i.e. dentifrices, mouthwashes, oral rinses and gels, etc.
). The first and perhaps most basic is the statement of identity, which must include the established name of the toothpaste, and must clearly identify the product as: "anticavity fluoride" (select one of the following as appropriate: "dentifrice," "toothp
aste," "tooth polish," or "tooth powder;" (optional: "dental")).}{\f1\fs28\super 28 }{\f1\fs28 
The regulation provides the definition of "dentifrice" as "An abrasive-containing dosage form (gel, paste, or powder) for delivering an anticaries drug to the teeth." ~ As regards products w
hich are arguably either cosmetics or drugs (such as some toothpastes discussed earlier), the FDA does not believe it necessary to include the phrase "drug product" on the label because the requirements for labeling only apply to drugs. If the product is 
indeed intended to be both a drug and a cosmetic, it must comply with the drug labeling requirements as well as those for cosmetics, found in 21 U.S.C. \'a7362.~"
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 Next, all toothpaste labels must list "Indication," followed by: "Aids }{\f1\fs30 in }{\f1\fs28 the prevention of dent
al (select one of the following: "cavities," "decay," "caries (decay)," or "caries (cavities). }{\b\f1\fs16 II)1131 }{\f1\fs28 Other non-misleading statements may be included under "Indication" provided that they describe this indication found in \'a7
355.50(b).
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par }\pard\plain \s28\qj\fi896\sl-566\slmult0\nowidctlpar\tx895\adjustright {\f1\fs28 Toothpaste labels must also include warning statements. 21 C.F.R. \'a7355.50(c)(1 )(1995) provides that all fluoride dentifrices (toothpastes and tooth powders)
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx895\adjustright {\f1\fs28 
\par }\pard\plain \s22\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 28 }{\f6 60 Fed. Reg. 52474, 52508(1995), as codified in 21 C.F.R. \'a7355.50 (a) (1995)
\par }\pard\plain \qj\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s22\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\adjustright {\i\f1\fs14 29 }{\f6 \'a7355.30(e)
\par }\pard\plain \qj\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s22\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 30 }{\f6 59 Fed. Reg. 5226, 5227(1994)
\par }\pard\plain \qj\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s23\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 31 }{\f6 21 C.F.R. \'a7355.50(b) (1995)
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
must include the following statement: "Keep out of the reach of children under 6 years of age." A recent addition to this warning is: "If you accidentally swallow more than u
sed for brushing, seek professional assistance or contact a Poison Control Center immediately."}{\f1\fs28\super 32}{\f1\fs28 
 This is due to the constant controversy over the toxicity of fluoride in larger amounts than are normally ingested during brushing of the teeth.
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 21 C.F.R. \'a73
55.50(d) deals with directions on toothpaste labels. The heading must be marked "Directions", and the required directions differ slightly depending on the total fluoride concentration of the active ingredients. See section labeled "Ingredients" for furthe
r discussion. According to the final monograph, the following statement must also be "prominently placed" on the principal display panel: "IMPORTANT: Read directions for proper use."~
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 (1) For toothpastes with a theoretical total fluorine concentration of 8
50 to 1150 parts per million (ppm), the directions must read "Adults and children 2 years of age and older:
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par }\pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years 
of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor."3' The word "minimize" is a recent change from the
 tentative final monograph, and was changed because, after performing studies on young children, the OTC panel concluded that children will often tend to swallow minute amounts of toothpaste during normal brushing.
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par }\pard\plain \s29\qj\fi732\sl-334\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 32 }{61 Fed. Reg. 52285, 52287 (1996)
\par }\pard\plain \qj\sl-334\slmult0\nowidctlpar\tx731\adjustright {
\par }\pard\plain \s30\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\tx1048\adjustright {\f6 ~\tab \'a7355.55
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
The previous version of the monograph spoke of "prevention" of swallowing instead of simply minimization, and the Panel concluded that there was no need to worry parents who observe their children swallowing small amounts of fluoride}{\f1\fs28\super 3~}{
\f1\fs28 
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 (2) For toothpastes with a theoretical total fluorine concentration of 1500 ppm, the directions include the same first sentence, but then also must include the following:

\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par }\pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 "Instruct children under 12 years of age in good brushing and rinsing habits (
to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Do not use unless directed by a dentist or doctor."3}{\f1\fs28\super 6 }{\f1\fs28 
These minor changes deal only with raising the recommended age for chi
ldren to use products with such high concentrations of fluorine, because the toxicity and danger of fluorosis is increased in younger children. An optional direction statement for such high-concentration fluoride toothpaste products is: "Adults and childr
en over 6 years of age may wish to use this extra-strength fluoride dentifrice if they reside in a nonfluoridated area or if they have a greater tendency to develop cavities."}{\f1\fs28\super 37}{\f1\fs28 
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 (3) For powdered toothpastes with a theoretical total fluorine concentration o
f 850 to 1150 ppm, the required directions contain much the same age restrictions as the higher-concentration toothpastes in part (2) above, along with specific directions on how to use the powdered pastes themselves.~
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 In the earty to mid I 980's, Crest and Colgate were the first to introduce 'Tartar Control"
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par 
\par }\pard\plain \s33\qj\li732\sl-436\slmult0\nowidctlpar\tx731\tx1060\adjustright {~\tab 60 Fed. Reg. 52474, 52488(1995) }{\f1\fs14 36 }{\f6 355.50(d) (ii)
\par }\pard\plain \qj\sl-436\slmult0\nowidctlpar\tx731\tx1060\adjustright {\f6 
\par }\pard\plain \s30\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\tx1048\adjustright {\f6 ~\tab \'a7355.50(f) (2)
\par }\pard\plain \qj\sl-306\slmult0\nowidctlpar\tx731\tx1048\adjustright {\f6 
\par }\pard\plain \s30\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\tx1048\adjustright {\f6 ~\tab \'a7355.50(d) (iii)
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 toothpaste, making anti-tartar and anti-plaque claims about their products. The FDA says t
hat it has not objected to plaque reduction claims "when the reduction of plaque is based on the abrasive action of the dentifrice during brushing" but has objected recently where such claims are attributed to one or more of the toothpaste's active ingred
i
ents. ~ The Agency did not take action against anti-tartar toothpastes when they first were marketed in 1983, viewing such claims as purely cosmetic, rather than drug claims subject to strict regulation.~ This lack of action was based on the fact that sup
r
agingival (above the gumline) tartar does not lead to disease, while subgingival tartar does. Thus, reasoned the FDA, a toothpaste that claims to reduce supragingival tartar is not making a disease-prevention claim, but rather merely a cosmetic one. There
f
ore, the FDA OTC Committee has ruled that anti-tartar products should say on the label that the substances only affect supragingival tartar and have no therapeutic effect on gingivitis (gum disease) if the manufacturer wants these claims to have purely co
smetic status. Further, the Agency will consider all unqualified tartar claims to be drug claims.}{\f1\fs28\super 41}{\f1\fs28 
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 All toothpastes, like other OTC drugs, are subject to the other labelling requirements of 21 U.S.C. \'a7352(1938) as well. \'a7
352(a) explains that a drug is deemed misbranded, and thus may not be entered into interstate commerce, if its labeling is false or misleading in any particular. This is why we do not see toothpastes on the market which claim on the label to guarantee no 
cavities during the user's lifetime, or other similarly ridiculous claims. \'a7352(b) indicates that the package containing the drug (in this case, the "pump" or tube
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par 
\par }\pard\plain \s30\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\tx1048\adjustright {\f6 ~\tab The Rose Sheet, Mar. 18, 1996
\par }\pard\plain \qj\sl-306\slmult0\nowidctlpar\tx731\tx1048\adjustright {\f6 
\par }\pard\plain \s23\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 40 }{\f6 The Pink Sheet, November 13, 1989
\par }\pard\plain \qj\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s23\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 41 }{\f6 The Rose Sheet, April 17, 1995
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 of toothpaste) must include the name and address of the manufacturer, packer, or distributor}{
\f1\fs28\super 42 }{\f1\fs28 and an accurate statement of the weight, measure, or numerical count of the contents of the package}{\f1\fs28\super 4~ }{\f1\fs28 Thus, toothpastes usually contain on the label the net weight of the tube or pump.
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par 
\par }\pard\plain \s17\qc\nowidctlpar\tx204\adjustright {\b\f1\fs28 Ingredients of Toothpaste
\par }\pard\plain \qj\nowidctlpar\tx204\adjustright {\b\f1\fs28 
\par 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 21 U.S.C. \'a7352 (1938), dealing with misbranded drugs or devices, also contains a final requirement that a drug is deemed misbranded unless it c
ontains the established name of the drug (i.e. the active ingredient), or, in the case of combination drugs discussed earlier, the established name and quantity of each active ingredient. The final monograph for anticaries drug products provides guidance 
as to what drugs and dosages of each will be accepted by the FDA as the active ingredient for toothpastes. 21 C. F. R. \'a7
355.10(1995) provides for three different acceptable active ingredients. First, sodium fluoride may be used, with .188 to .254 percent so
dium fluoride (in paste or powdered form), with slightly higher requirements of available fluorine ion in the powder than in the paste. Secondly, sodium monofluorophosphate has also been approved by the Panel, in a .654 to .884 percent concentration for d
e
ntifrices containing average amounts of fluorine, or in a 1.153 percent concentration for high-fluorine formulas. Lastly, the OTC Panel has also approved toothpastes with stannous fluoride as the active ingredient, in a .351 to .474 percent concentration,
 and with lower available fluorine ion requirements in formulas containing
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par }\pard\plain \s22\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 42 }{\f6 \'a7352(b) (1) (1938)
\par }\pard\plain \qj\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s22\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f6 ~ \'a7352(b) (2)
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 calcium pyrophosphate than in those using a different element as an abrasive."
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
There has also been much regulation regarding the use of colored dyes in toothpastes. D&C Red No. 8 and No. 9, which were approved for use in dentifrices in I 983~, were then prohibited from being added to dentifrices and mouthwashes after January 5, 1 98
7~~ D&C Red No. 33 and No. 36 are similarly prohibited from use in mouthwashes and toothpastes, though they have been approved for other ingested drugs.}{\f1\fs28\super 47 }{\f1\fs28 
FD&C Red No. 40, however, has been approved for use in dentifrices that are cosmetics~ and eventually for cosmetics generally }{\f1\fs8 ~. }{\f1\fs28 
Similarly, D&C Orange No. 5 has been approved for drug and cosmetic dentifrices.~ D&C Orange No. 17 has been approved for use in dentifrices, but only at not more than .002 percent of the pure dye by weight of the dentifrice.}{\f1\fs28\super 51 }{
\f1\fs28 FD&C Yellow No. 5 may also be used in dentifrices that are drugs and cosmetics, and the labels of these dentifrices need not necessarily declare the presence of this dye, as must other products.}{\f1\fs28\super 52}{\f1\fs28 
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 Another ingredient permitted to be used in the manufacture 
of toothpastes is mica. The FDA ruled in 52 Fed. Reg. 29664(1987) that it is safe to use mica in toothpastes that are
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par 
\par }\pard\plain \s30\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\tx1048\adjustright {\f6 ~\tab \'a7355.10 (a) (1)\emdash (2) (1995)
\par }\pard\plain \qj\sl-306\slmult0\nowidctlpar\tx731\tx1048\adjustright {\f6 
\par }\pard\plain \s30\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\tx1048\adjustright {\f6 ~\tab 48 Fed. Reg. 13976, 13978(1982)
\par }\pard\plain \qj\sl-306\slmult0\nowidctlpar\tx731\tx1048\adjustright {\f6 
\par }\pard\plain \s23\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\adjustright {\i\f1\fs14 46 }{\f6 51 Fed. Reg. 43877(1986)
\par }\pard\plain \qj\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s22\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f6 ~ 53 Fed. Reg. 33110, 33120(1988) and 53 Fed. Reg. 29024, 29031 (1988)
\par }\pard\plain \qj\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s22\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 48 }{\f6 39 Fed. Reg. 28278(1974)
\par }\pard\plain \qj\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s33\qj\li732\sl-436\slmult0\nowidctlpar\tx731\tx1060\adjustright {~\tab 39 Fed. Reg. 44198(1974)
\par }\pard\plain \qj\sl-436\slmult0\nowidctlpar\tx731\tx1060\adjustright {
\par }\pard\plain \s33\qj\li732\sl-436\slmult0\nowidctlpar\tx731\tx1060\adjustright {~\tab 49 Fed. Reg. 31852(1984)
\par }\pard\plain \qj\sl-436\slmult0\nowidctlpar\tx731\tx1060\adjustright {
\par }\pard\plain \s30\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\tx1048\adjustright {\f6 ~\tab 48 Fed. Reg. 5262, 5264(1983)
\par }\pard\plain \qj\sl-306\slmult0\nowidctlpar\tx731\tx1048\adjustright {\f6 
\par }\pard\plain \s23\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 52 }{\f6 50 Fed. Reg. 23815, 23817(1985)
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 cos
metics as well as drugs, in response to a petition from the Procter and Gamble company. Sodium is also permitted (see "Ingredients"), and toothpastes and mouthwashes are exempt from the labeling requirement (listing the amount of sodium in the product) si
nce these products are not intended for oral ingestion. At this time, insufficient data has been brought to the attention of the FDA as to the absorption of sodium when these products are used to warrant a sodium labeling requirement.~
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par 
\par }\pard\plain \s17\qc\nowidctlpar\tx204\adjustright {\b\f1\fs28 The Fluoride Issue
\par }\pard\plain \qj\nowidctlpar\tx204\adjustright {\b\f1\fs28 
\par 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\b\f1\fs28 A }{\f1\fs28 
specific ingredient found in toothpastes that has come under much debate due to its toxicity is fluoride. Humans, mostly children, are at risk of developing fluorosis of the teeth if exposure to fluoride is not curbed at some point, which can leave tee
th greatly discolored and stained. The FDA, using a cost-benefit analysis, thus feels that children under 6 should not use toothpastes exceeding 1150 ppm of total fluoride.}{\f1\fs28\super 5}{\f1\fs28 
' The Agency, however, has determined that a 1500-ppm theoretical total fluoride le
vel is safe for children over 6 and for adults (based on two clinical studies), approving an NDA for such an extra-strength fluoride dentifrice in 1986. However, since fluorosis is increasing among children in this country, the FDA cautions against those 
below the age of 6 from using such products. The Agency has also ruled that fluoride levels above I 500 ppm have not been proven safe and effective, and thus they were excluded from the final monograph for anticaries drug
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par 
\par 
\par }\pard\plain \s33\qj\li732\sl-436\slmult0\nowidctlpar\tx731\tx1060\adjustright {~\tab 61 Fed. Reg. 17798, 17800(1996)
\par }\pard\plain \qj\sl-436\slmult0\nowidctlpar\tx731\tx1060\adjustright {
\par }\pard\plain \s30\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\tx1048\adjustright {\f6 ~\tab 60 Fed. Reg. 52474, 52479(1995)
\par }{\fs20 \page \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\sl-306\slmult0\nowidctlpar\tx204\adjustright {\fs20 
\par }\pard\plain \s34\li328\nowidctlpar\tx328\pvpg\phpg\posx2148\posy13759\absw2001\dxfrtext38\dfrmtxtx38\dfrmtxty38\adjustright {\f6 Id.
\par 
\par }\pard\plain \s35\li328\nowidctlpar\tx204\tx328\pvpg\phpg\posx2148\posy13759\absw2001\dxfrtext38\dfrmtxtx38\dfrmtxty38\adjustright {\f1\fs14 56 }{\f6 Id. at 52483
\par }\pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 products}{\f1\fs28\super 55 }{\f1\fs28 
The FDA, after extensive testing, has also stated that presently there is not enough evidence to show that a low-fluoride dentifrice is safe and effective for children 2 to 6 years old, or to determine the proper fluoride concentration for such a low-leve
l
 dentifrice, and thus these too have been left out of the final monograph. Note as well that, despite this ongoing debate, the final monograph for anticaries drug products still contains no requirement that toothpastes containing fluoride label the quanti
ty of fluoride within the product. ~
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par 
\par }\pard\plain \s17\qc\nowidctlpar\tx204\adjustright {\b\f1\fs28 International Regulation of Toothpaste
\par }\pard\plain \qj\nowidctlpar\tx204\adjustright {\b\f1\fs28 
\par 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
Many of the same issues facing the FDA in America are also being faced currently by other advanced countries as they attempt to protect their citizens from the possible evils of
 misbranded or poorly formulated drugs. This issue is especially important with a product such as toothpaste, which is placed in the mouth and has the potential to be ingested. England, for instance, recently went through an incident which may lead to inc
r
eased labeling regulation of fluoride-containing toothpastes. Colgate-Palmolive agreed to make a settlement payment to a family whose child had his teeth permanently discolored as a result of the same fluorosis problem that has concerned the FDA in this c
ountry. In fact, now more than 300 British families are making similar claims against
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 toothpaste manufacturers.}{\f1\fs28\super 57 }{\f1\fs28 
As a result of these claims, leading supermarket chains in England are considering introducing new fluoride-free toothpastes 
themselves and adding warnings against swallowing the product on toothpaste labels, which do not currently exist. Current labeling requirements in England require instructions that only a pea-sized amount should be used, and that children under 7 years of
 age should be supervised when brushing their teeth.}{\f1\fs28\super 55 }{\f1\fs28 Additional regulations require that manufacturer's claims merely be not misleading, since toothpastes fall under cosmetic and not medical regulations.}{\f1\fs28\super 55 }{
\f1\fs28 A spokesman for the Department of Health, however, says there are no plans to change the current level of governmental regulation.
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par }\pard\plain \s18\qj\fi340\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 The European Union, facing similar problems, strictly regulates cosmetic products, which include toothpastes. These regulations, much like in America, focus largely on the c
omposition and labeling of such products. The EU has also established a post with the power to receive complaints from any citizen of the EU with a consumer issue.~ Canada has similar standards for which claims may be made on labels, and for strengths of 
s
odium fluoride, acidulated phosphate fluoride, and stannous fluoride. In Canada, manufacturers may make various cavity-prevention claims, but several warnings are required on oral care products. These include warnings against swallowing the product, and t
hat children
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx340\adjustright {\f1\fs28 
\par 
\par 
\par }\pard\plain \s23\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f6 ~ Jackson, Linda, "Toothpaste to carry chemical warning", }{\f6\ul The Sunday Telegraph}{\f6 , London, Sunday Dec. 1, 1996
\par }\pard\plain \qj\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par 
\par }\pard\plain \s36\qj\fi732\sl-453\slmult0\nowidctlpar\tx731\tx1048\adjustright {\f6 ~\tab Bloor, Caroline, "Consumer News: Brushing Up on a Whiter Smile", }{\f6\ul The Daily Telegraph}{\f6 , London, Monday, Feb. 26, 1996
\par }\pard\plain \qj\sl-453\slmult0\nowidctlpar\tx731\tx1048\adjustright {\f6 
\par }\pard\plain \s22\qj\fi732\sl-294\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 60 }{Lansman, }{\f6 Nicholas, "Consumer Protection in the EU", ~ap }{\f6\ul Perfumery }{\ul & Cosmetics}{, Monday, July 1, 1996
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 should be supervised when using toothpaste.}{\f1\fs28\super 61}{\f1\fs28 
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 
\par }\pard\plain \s26\qj\fi516\sl-566\slmult0\nowidctlpar\tx515\adjustright {\f1\fs28 In Singapore, June 1997 marks the deadline after which all cosmetic products, including toothpastes,
 will have to bear content labels for the first time. These measures are designed to protect members of the public from using products containing ingredients to which they are allergic, as well as to help doctors determine which substances cause allergic 
reactions in their patients. All cosmetic products in Singapore will also have to contain batch numbers for the first time.}{\f1\fs28\super 62 }{\f1\fs28 
The country's Health Ministry says it will be illegal to manufacture, import, sell, or supply any cosmetic product that does not meet these new specifications.
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx515\adjustright {\f1\fs28 
\par 
\par }\pard\plain \s17\qc\nowidctlpar\tx515\adjustright {\b\f1\fs28 Conclusion
\par }\pard\plain \qj\nowidctlpar\tx515\adjustright {\b\f1\fs28 
\par 
\par }\pard\plain \s26\qj\fi516\sl-566\slmult0\nowidctlpar\tx515\adjustright {\f1\fs28 
It can be seen that the FDA indeed imposes rather strict regulations on toothpaste products in this country. For the purpose of fulfilling its mission to protect the public from unsafe and ineffective products, f
luoride toothpaste is regulated as a drug under the 1938 Food Drug and Cosmetic Act. The FDA attempts to ensure the safety of toothpastes by requiring certain testing, and by regulating the ingredients used in the product, as well as the packaging and the
 warnings thereon. The Agency also uses testing procedures and various standards to be sure the toothpastes on the market are effective. The OTO drug review resulted in a final monograph for anticaries drug products in late I 995, and this
\par }\pard\plain \qj\sl-566\slmult0\nowidctlpar\tx515\adjustright {\f1\fs28 
\par }\pard\plain \s23\qj\fi732\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 61 }{\f6 ~ "Oral Care Products: Canada--New Labeling Regulations", Sunday, Sep. 1, 1996
\par }\pard\plain \qj\sl-306\slmult0\nowidctlpar\tx731\adjustright {\f6 
\par }\pard\plain \s29\qj\fi732\sl-334\slmult0\nowidctlpar\tx731\adjustright {\f1\fs14 62 }{"All cosmetic products to show contents, some to be licensed", }{\ul Singapore Straits Times}{, Saturday, June 15, 1996
\par }{\fs20 \page }{\f1\fs28 \sect }\sectd \sbknone\linex0\headery1440\sectdefaultcl \pard\plain \s16\qj\sl-566\slmult0\nowidctlpar\tx204\adjustright {\f1\fs28 monog
raph provides the three acceptable active drugs for use in toothpaste products, as well as other allowable ingredients. Strict labeling requirements are also promulgated in the C.F.R. for toothpastes, to ensure that the public is given all the information
 
deemed necessary by the OTC Panel. Finally, it is apparent that the FDA imposes similar, if not more stringent, requirements on its toothpaste manufacturers than other countries impose on theirs, mostly dealing with the labeling and composition of toothpa
ste products. One can only hope that the stringency of these requirements will continue to protect the American people from a major toothpaste scare, as have occurred with various other consumer products over the last few decades.
\par }}