COSMETICSCosmetics & U.S. LawIntroductionAmong the important differences between requirements for cosmetics in the United States and various other countries are the legal definitions of drugs and cosmetics, restrictions on the use of color additives and other ingredients, and registration requirements. Some products regulated as cosmetics in Europe, for instance, are regulated as drugs in the United States. Sunscreens are a case in point. There also are differences regarding prohibited and restricted ingredients, particularly color additives. Some countries may require cosmetic companies to register their establishments and list products and ingredients with the government; in the United States, cosmetic registration is voluntary but highly recommended.

How U.S. Law Defines CosmeticsThe Federal Food, Drug & Cosmetic Act (FD&C Act) defines cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance." Included in this definition are products such as skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.

How U.S. Law Defines DrugsThe FD&C Act defines drugs as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease...and articles (other than food) intended to affect the structure or any function of the body of man or other animals." Over-the-counter (OTC) drugs are drugs that can be purchased without a doctor's prescription.

The agency is conducting a review of all OTC drugs to establish monographs (rules) under which the drugs are generally recognized as safe and effective, and not misbranded. These rules are established on a class-by-class basis (for example, fluoride dentifrices, cough suppressants, and antihistamines). OTC drugs must meet the requirements of the appropriate class once that rule is published as a final regulation.

If an OTC drug does not meet the requirements of the appropriate final rule, it is considered a misbranded drug and a "new drug." A "new drug" must have an approved New Drug Application (NDA) before it may be introduced into interstate commerce. In addition, drug manufacturers must comply with Good

Manufacturing Practice regulations.

Certain claims may cause a product to qualify as a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells.

How a Product Can Be Considered Both a Cosmetic and a DrugOTC drugs are often marketed side by side with cosmetics, and some products qualify both as cosmetics and as OTC drugs. This may happen when a product has two intended uses, with ingredients intended to do two different things. For instance, a shampoo is a cosmetic, since its intended use is to cleanse the hair. An anti-dandruff treatment is a drug, because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims.

Assuring Ingredient and Product SafetyCosmetics imported into the United States, both ingredients and finished products, must meet the same criteria for safety and labeling as those manufactured domestically.

FDA does not pre-approve cosmetic products or ingredients, with the important exception of color additives. However, cosmetic firms are responsible for marketing safe, properly labeled products; using no prohibited ingredients; and adhering to limits on restricted ingredients. It is also considered good practice to follow industry safety guidelines and recommendations.

Before marketing a product containing a color additive in the United States, it is essential to determine whether the additive is approved for its intended use. A number of color additives must be certified for purity in FDA labs if they are to be used legally in a product marketed in the United States.

Although U.S. regulations do not specify any particular testing regimens for cosmetic products or ingredients, it is the cosmetic company's responsibility to substantiate product and ingredient safety prior to marketing.

Cosmetic RegistrationCosmetic companies may register in the United States through FDA's Voluntary Cosmetic Registration Program (VCRP). If a cosmetic manufacturer files a product

formulation with the VCRP, FDA can advise the company if it is inadvertently using a non-permitted color additive or other prohibited or restricted ingredients. In that way, manufacturers can correct their formulations before attempting to market them in the United States, thus avoiding the risk of having their products detained and denied entry into the United States because of a prohibited ingredient.

Key Legal Concepts: Interstate Commerce, Adulterated, and MisbrandedThe Federal Food, Drug, and Cosmetic Act prohibits the distribution of cosmetics that are adulterated or misbranded in interstate commerce. Here is an introduction to what those terms mean.

IntroductionThe Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibits, among other things,

"The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded" [FD&C Act, sec. 301(a); 21 U.S.C. 331(a)]. "The adulteration or misbranding of any food, drug, device or cosmetic in interstate commerce" [FD&C Act, sec. 301(b); 21 U.S.C. 331(b)]. "The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise"[FD&C Act, sec. 301(c); 21 U.S.C. 331(c)]. "The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded" [FD&C Act, sec. 301(k); 21 U.S.C. 331(k)].

This means that nearly everyone involved in cosmetics in interstate commerce, such as manufacturers, packers, distributors, and retailers, is responsible for assuring that he or she is not dealing in products that are adulterated or misbranded, even if someone else caused the adulteration or misbranding in the first place. If you introduce it into interstate commerce or receive it in interstate commerce, you are responsible. The law applies to components and packaging as well as to finished products.

The FD&C Act describes what constitutes interstate commerce, adulteration, and misbranding. It also authorizes FDA to take legal action if cosmetics are

adulterated or misbranded. In addition, the Fair Packaging and Labeling Act (FPLA) requires specific label information. Violations of the FPLA result in misbranding.

What the FD&C Act Means by "Interstate Commerce"Section 201(b) of the FD&C Act [21 U.S.C. 321(b)] tells what circumstances place a product in interstate commerce:

"(1) commerce between any State or Territory and any place outside thereof, and(2) commerce within the District of Columbia or within any other Territory not organized with a legislative body."

"Interstate commerce" applies to all steps in a product's manufacture, packaging, and distribution. It is very rare that a cosmetic product on the market is not in "interstate commerce" under the law. For example, at least some of your ingredients or packaging most likely originate from out of state, or even out of the country. Likewise, it is foreseeable that your products will leave the state. Although there are certain exemptions [21 CFR 701.9], factors such as these generally cause the requirements of the FD&C Act to apply to your products.

What Makes a Cosmetic AdulteratedSection 601 of the FD&C Act [21 U.S.C. 361] describes what causes a cosmetic to be considered adulterated:

"A cosmetic shall be deemed to be adulterated--

(a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or, under such conditions of use that are customary or usual, except that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: "Caution-This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.", and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term "hair dye" shall not include eyelash dyes or eyebrow dyes. (b) If it consists in whole or in part of any filthy, putrid, or decomposed substance. (c) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have

been rendered injurious to health. (d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health. (e) If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 721(a)." (Section 721(a) of the FD&C Act [21 U.S.C. 379(a)], states the circumstances under which color additives are deemed unsafe.)

Note that the law addresses-- the composition of the product itself, the conditions under which the product is manufactured, shipped, and stored, the product's container, and an exception for coal-tar hair dyes.

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What Makes a Cosmetic MisbrandedSection 602 of the FD&C Act [21 U.S.C. 362] describes what causes a cosmetic to be considered misbranded:

"A cosmetic shall be deemed to be misbranded--

(a) If its labeling is false or misleading in any particular. (b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary. (c) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (d) If its container is so made, formed, or filled as to be misleading. (e) If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under section 721. This paragraph shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair

dyes (as defined in the last sentence of section 601(a)). (f) If its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.

Note that under the FD&C Act, the term "misbranding" applies to-- False or misleading information,* Lack of required information, Conspicuousness and readability of required information, Misleading packaging, Improper packaging and labeling of color additives, and Deficiencies where the Poison Prevention Packaging Act requires special packaging.

*Note: According to the FD&C Act, a determination that labeling is "misleading" includes considering both what the label says and what it fails to reveal:

"If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual" (FD&C Act, sec. 201(n); 21 U.S.C. 321(n)].

In addition, a cosmetic marketed in violation of the FPLA or any regulations issued under its authority is considered misbranded within the meaning of the FD&C Act [15 U.S.C.1456(a)]. For cosmetics offered for sale as consumer commodities, the FPLA--

requires further label information, such as the product's identity [15 U.S.C.1453], and authorizes the implementation of regulations to specify the proper presentation of required label information, require an ingredient declaration, and prevent deceptive packaging [15 U.S.C.1454 (c)]

The FPLA defines a consumer commodity, as it applies to FDA-regulated products, as:

"any food, drug, device, or cosmetic (as those terms are defined by the Federal Food, Drug, and Cosmetic Act ..., and any other article, product, or

commodity of any kind or class which is customarily produced or distributed for sale through retail sales agencies or instrumentalities for consumption by individuals, or use by individuals for purposes of personal care or in the performance of services ordinarily rendered within the household, and which usually is consumed or expended in the course of such consumption or use." [15 U.S.C.1459(a)]

Note that the FPLA defines a consumer commodity by the way it is marketed, not the way it is labeled. Labeling a product with words such as "For Professional Use Only" does not keep your product from being considered a consumer commodity under the FPLA.

Labeling regulations are very complex. Detailed information on cosmetic labeling is available in FDA's Cosmetic Labeling Manual and the labeling regulations themselves [21 CFR 701].

Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)Back to Cosmetics & U.S. Law

Whether a product is a cosmetic or a drug under the law is determined by a product's intended use. Different laws and regulations apply to each type of product. Firms sometimes violate the law by marketing a cosmetic with a drug claim or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs.

How does the law define a cosmetic?

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.

How does the law define a drug?

The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)].

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How can a product be both a cosmetic and a drug?

Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.

What about "cosmeceuticals"?

The FD&C Act does not recognize any such category as "cosmeceuticals." A product can be a drug, a cosmetic, or a combination of both, but the term "cosmeceutical" has no meaning under the law.

How is a product's intended use established?

Intended use may be established in a number of ways. The following are some examples:

Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin (pigment) in the skin, or regenerate cells. Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do. Ingredients that cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.

This principle also holds true for "essential oils." For example, a fragrance

marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain "aromatherapy" claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use. Similarly, a massage oil that is simply intended to lubricate the skin and impart fragrance is a cosmetic, but if the product is intended for a therapeutic use, such as relieving muscle pain, it's a drug.

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How are the laws and regulations different for cosmetics and drugs?

The following information is not a complete treatment of cosmetic or drug laws and regulations. It is intended only to alert you to some important differences between the laws and regulations for cosmetics and drugs in the areas of approval, good manufacturing practice, registration, and labeling. Questions regarding laws and regulations for drugs should be directed to FDA's Center for Drug Evaluation and Research (CDER).

How approval requirements are different

Under the FD&C Act, cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market. Drugs, however, must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a "monograph" for a particular drug category, as established by FDA's Over-the-Counter (OTC) Drug Review. These monographs specify conditions whereby OTC drug ingredients are generally recognized as safe and effective, and not misbranded. Certain OTC drugs may remain on the market without an NDA approval until a monograph for its class of drugs is finalized as a regulation. However, once FDA has made a final determination on the status of an OTC drug category, such products must either be the subject of an approved NDA [FD&C Act, sec. 505(a) and (b)], or comply with the appropriate monograph for an OTC drug. (A note on the term "new drug": Despite the word "new," a "new drug" may have been in use for many years. If a product is intended for use as a drug, it must comply with the requirements outlined above.)

What do these terms mean?

An NDA is the vehicle through which drug sponsors formally propose that FDA approve a pharmaceutical for sale and marketing in the United States. FDA only approves an NDA after determining, for example, that the data is adequate to show the drug's safety and effectiveness for its proposed use and that its benefits outweigh the risks. The NDA system is also used for new ingredients and for new indications entering the OTC marketplace for the first time. For example, the newer OTC products (previously available only by prescription) are first approved through the NDA system, and their "switch" to

OTC status is then approved, also through the NDA system. FDA has published monographs, or rules, for a number of OTC drug categories. These monographs, which are published in the Federal Register, state requirements for categories of nonprescription drugs, such as what ingredients may be used and for what intended use. Among the many nonprescription drug categories covered by OTC monographs are

o acne medicationso treatments for dandruff, seborrheic dermatitis, and psoriasiso sunscreens

You can find information on FDA's website, under "Development and Approval Process (Drugs)," especially "How Drugs Are Developed and Approved." If you still have questions about NDAs and OTC monographs, or any other aspect of drug regulation, please contact CDER. You can contact CDER's Division of Drug Information, Small Business Assistance at CDERSmallBusiness@fda.hhs.gov or, for general drug-related inquiries, CDER's Division of Drug Information at druginfo@fda.hhs.gov.

How good manufacturing practice requirements are different

Good manufacturing practice (GMP) is an important factor in helping to assure that your cosmetic products are neither adulterated nor misbranded. However, while FDA has provided guidelines for cosmetic GMP (see "Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist"), no regulations set forth specific GMP requirements for cosmetics. In contrast, the law requires strict adherence to GMP requirements for drugs, and there are regulations specifying minimum current GMP requirements for drugs [Title 21 of the Code of Federal Regulations (CFR), parts 210 and 211]. Failure to follow GMP requirements causes a drug to be adulterated [FD&C Act, sec. 501(a)(2)(B)].

How registration requirements are different

FDA maintains the Voluntary Cosmetic Registration Program, or VCRP, for cosmetic establishments and formulations [21 CFR 710 and 720]. As its name indicates, this program is voluntary. The FD&C Act does not require cosmetic firms to register their establishments or list their product formulations with FDA. In contrast, it is mandatory for drug firms to register their establishments and list their drug products with FDA [FD&C Act, sec. 510; 21 CFR 207]. See Drug Listing and Registration System (DRLS and eDRLS).

How labeling requirements are different

A cosmetic product must be labeled according to cosmetic labeling regulations. See the Cosmetic Labeling Manual for guidance on cosmetic labeling and links to the regulations related to cosmetic labeling. OTC drugs must be labeled

according to OTC drug regulations, including the "Drug Facts" labeling, as described in 21 CFR 201.66 Combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling. For example, the drug ingredients must be listed alphabetically as "Active Ingredients," followed by cosmetic ingredients, listed in descending order of predominance as "Inactive Ingredients."

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And what if it's "soap"?

Soap is a category that needs special explanation. That's because the regulatory definition of "soap" is different from the way in which people commonly use the word. Products that meet the definition of "soap" are exempt from the provisions of the FD&C Act because—even though Section 201(i)(1) of the act includes "articles...for cleansing" in the definition of a cosmetic—Section 201(i)(2) excludes soap from the definition of a cosmetic.

How FDA defines "soap"

Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when

the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and the product is labeled, sold, and represented solely as soap [21 CFR 701.20].

Products that meet this definition of soap are regulated by the Consumer Product Safety Commission (CPSC), not by FDA. Please direct questions about these products, such as safety and labeling requirements, to CPSC.

If a cleanser does not meet all of these criteria...

If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example:

If a product

consists of detergents, or primarily of alkali salts of fatty acids, and is intended not only for cleansing but also for other cosmetic uses,

it is regulated as a cosmetic. Examples of cosmetic uses include making the user more attractive, by acting as a deodorant, imparting fragrance to the user, or moisturizing the skin.

If a product

consists of detergents, or primarily of alkali salts of fatty acids, and is intended not only for cleansing but also to cure, treat, or prevent disease, or to affect the structure or any function of the human body,

it is regulated as a drug, or possibly both a drug and a cosmetic. Examples include antibacterial cleansers and cleansers that are also intended to treat acne.

If a product

is intended solely for cleansing the human body, has the characteristics consumers generally associate with soap, and does not consist primarily of alkali salts of fatty acids,

it may be identified in labeling as soap, but it is regulated as a cosmetic.

"Cosmeceutical"Consumers and manufacturers sometimes have questions about the term "cosmeceutical."

While the Federal Food, Drug, and Cosmetic Act (FD&C Act) does not recognize the term "cosmeceutical," the cosmetic industry uses this word to refer to cosmetic products that have medicinal or drug-like benefits.

The FD&C Act defines drugs as those products that cure, treat, mitigate or prevent disease or that affect the structure or function of the human body. While drugs are subject to a review and approval process by FDA, cosmetics are not approved by FDA prior to sale. If a product has drug properties, it must be approved as a drug.

How does FDA regulate cosmetics? Are they FDA approved?FDA's legal authority over cosmetics is different from other products we regulate, such as drugs, biologics, and medical devices. FDA does not have the legal authority to approve cosmetics before they go on the market, although we do approve color additives used in them (except coal tar hair dyes). However, under the law, cosmetics must not be "adulterated" or "misbranded." For example, they must be safe for consumers when used as directed in their labeling or under customary conditions of use, and they must be properly labeled. Companies and individuals who market cosmetics have a legal responsibility for the safety and

labeling of their products.

FDA can take action against a cosmetic on the market if we have reliable information showing that it is adulterated or misbranded. FDA takes action within our legal authority, based on public health priorities and available resources.

Overview of Labeling RequirementsThe following information is a brief introduction to labeling requirements. For a more thorough explanation of cosmetic labeling regulations, refer to FDA's Cosmetic Labeling Guide and the cosmetic labeling regulationsthemselves (21 CFR parts 701 and 740). Firms also may wish to discuss their labeling needs with a consultant.

Proper labeling is an important aspect of putting a cosmetic product on the market. FDA regulates cosmetic labeling under the authority of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). These laws and their related regulations are intended to protect consumers from health hazards and deceptive practices and to help consumers make informed decisions regarding product purchase.

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It is illegal to introduce a misbranded cosmetic into interstate commerce, and such products are subject to regulatory action. Some of the ways a cosmetic can become misbranded are:

its labeling is false or misleading, its label fails to provide required information, its required label information is not properly displayed, and its labeling violates requirements of the Poison Prevention Packaging Act of 1970 [FD&C Act, sec. 602; 21 U.S.C. 362].

Does FDA pre-approve cosmetic product labeling?

No. FDA does not have the resources or authority under the law for pre-market approval of cosmetic product labeling. It is the manufacturer's and/or distributor's responsibility to ensure that products are labeled properly. Failure to comply with labeling requirements may result in a misbranded product.

Some labeling terms to know

Before proceeding with a discussion of labeling requirements, it is helpful to know what some labeling terms mean:

Labeling. This term refers to all labels and other written, printed, or

graphic matter on or accompanying a product [FD&C Act, sec. 201(m); 21 U.S.C. 321(m)]. Principal Display Panel (PDP). This is the part of the label most likely displayed or examined under customary conditions of display for sale [21 CFR 701.10]. Information Panel. Generally, this term refers to a panel other than the PDP that can accommodate label information where the consumer is likely to see it. Since the information must be prominent and conspicuous [21 CFR 701.2(a)(2)], the bottom of the package is generally not acceptable for placement of required information, such as the cosmetic ingredient declaration.

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Is it permitted to label cosmetics "FDA Approved"?

No. As part of the prohibition against false or misleading information, no cosmetic may be labeled or advertised with statements suggesting that FDA has approved the product. This applies even if the establishment is registered or the product is on file with FDA's Voluntary Cosmetic Registration Program (VCRP) (see 21 CFR 710.8 and 720.9, which prohibit the use of participation in the VCRP to suggest official approval). False or misleading statements on labeling make a cosmetic misbranded [FD&C Act, sec. 602; 21 U.S.C. 362].

What about therapeutic claims?

Be aware that promoting a product with claims that it treats or prevents disease or otherwise affects the structure or any function of the body may cause the product to be considered a drug. FDA has an Import Alert in effect for cosmetics labeled with drug claims. For more information on drug claims, refer to Is It a Drug, a Cosmetic, or Both? (Or Is It Soap?).

How should products be labeled if they are both drugs and cosmetics?

If a product is an over-the-counter (OTC) drug as well as a cosmetic, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling [21 CFR 701.3(d)]. The drug ingredients must appear according to the OTC drug labeling requirements [21 CFR 201.66(c)(2) and (d)] and the cosmetic ingredients must appear separately, in order of decreasing predominance [21 CFR 201.66(c)(8) and (d)]. Contact the Center for Drug Evaluation and Research (CDER) for further information on drug labeling.

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What languages are acceptable?

All labeling information that is required by law or regulation must be in English. The only exception to this rule is for products distributed solely in a U.S. territory where a different language is predominant, such as Puerto Rico. If the label or labeling contains any representation in a foreign language, all label information required under the FD&C Act must also appear in that language [21 CFR 701.2(b)]. For information on dual declaration of ingredients, see Ingredient Names.

What labeling information is required?

The following information must appear on the principal display panel:

An identity statement, indicating the nature and use of the product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration [21 CFR 701.11]. An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure [21 CFR 701.13].

The following information must appear on an information panel: Name and place of business. This may be the manufacturer, packer, or distributor. [21 CFR 701.12]. Distributor statement. If the name and address are not those of the manufacturer, the label must say "Manufactured for..." or "Distributed by..." [21 CFR 701.12]. Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded [21 CFR 1.21]. An example is directions for safe use, if a product could be unsafe if used incorrectly. Warning and caution statements. These must be prominent and conspicuous. The FD&C Act and related regulations specify warning and caution statements related to specific products [21 CFR part 700]. In addition, cosmetics that may be hazardous to consumers must bear appropriate label warnings [21 CFR 740.1]. An example of such hazardous products is flammable cosmetics. Ingredients. If the product is sold on a retail basis to consumers, even it it is labeled "For professional use only" or words to that effect, the ingredients must appear on an information panel, in descending order of predominance. [21 CFR 701.3]. Remember, if the product is also a drug, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling, as stated above.