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U.S. Department of Health and Human Services
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CFSAN/Office of Cosmetics and Colors
July 8, 2002


Is It a Cosmetic, a Drug, or Both?
(or Is It Soap?)

The legal difference between a cosmetic and a drug 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 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, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material 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)].

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. Among them are:

This principle also holds true for essential oils in fragrance products. 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.

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. You should direct questions regarding laws and regulations for drugs to CDER.

How approval requirements are different

FDA does not have a premarket approval system for cosmetic products or ingredients, with the important exception of color additives. Drugs, however, are subject to FDA approval. Generally, drugs must either receive premarket approval by FDA or conform to final regulations specifying conditions whereby they are generally recognized as safe and effective, and not misbranded. Currently, certain -- but not all -- over-the-counter (OTC) drugs (that is, non-prescription drugs) that were marketed before the beginning of the OTC Drug Review (May 11, 1972) may be marketed without specific approval pending publication of final regulations under the ongoing OTC Drug Review. Once a regulation covering a specific class of OTC drugs is final, those drugs must either -

What do these terms mean?

A note on "new drugs": 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, no matter how ancient or "traditional" its use may be, once the agency has made a final determination on the status of an OTC drug product it must have an approved NDA or comply with the appropriate OTC monograph to be marketed legally in interstate commerce. Certain OTC drugs may remain on the market without NDA approval pending final regulations covering the appropriate class of drugs.

Where to learn more about NDAs and OTC monographs: If you have questions about NDAs and OTC monographs, you should address them to CDER. The CDER Handbook provides an introduction to the drug approval and OTC monograph processes. Other resources, also available on CDER's Web site, provide additional information on these subjects.

How good manufacturing practice requirements are different

Good manufacturing practice (GMP) is an important factor in assuring that your cosmetic products are neither adulterated nor misbranded. However, 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. 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].

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. OTC drugs must be labeled according to OTC drug regulations, including the "Drug Facts" labeling, as described in 21 CFR 201.63. 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 order of predominance as "Inactive Ingredients."

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 --

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 --

it is regulated as a cosmetic.

If a product --

it is regulated as a drug.

If a product --

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

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