Is It a Cosmetic, a Drug, or Both? Or Just Soap?

Whether a product is legally classified as a cosmetic or a drug depends on the product's intended use. Different types of products are subject to different laws and regulations. Companies sometimes violate the law by marketing a cosmetic with claimed drug benefits, or by marketing a drug as a cosmetic without complying with the requirements for drugs. How does the law define a cosmetic? The Federal Food, Drug, and 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" [FD&C Act, Section 201(i)]. Products covered by this definition include skin moisturizers, perfumes, lipsticks, nail polishes, makeup, cleansing shampoos, permanent waves, hair dyes, and deodorants, as well as any substance intended for use as a cosmetic product ingredient. The 2022 Modernization of Cosmetics Regulation Act (MoCRA) amends the FD&C Act to include the definition of "cosmetic product," namely "a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product" [FD&C Act, Section 361]. This new term applies to these amended provisions of the FD&C Act. How does the law define a drug? The FD&C Act partly defines drugs by intended use, namely "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, Section 201(g)(1)]. How can a product be both a cosmetic and a drug? Some products meet the definitions of both cosmetic and drug. This can happen if a product has multiple intended uses. For example, a dandruff shampoo is both a cosmetic, because its intended use is to cleanse the hair, and a drug, because its intended use is to treat dandruff. Other cosmetic/drug combinations include: toothpaste that contains fluoride and is marketed to freshen breath and clean teeth; deodorants that also have antiperspirant functions; and moisturizers and makeup marketed with sunscreen functions. Such products must comply with both cosmetic and drug requirements. What is a "cosmeceutical"? The FD&C Act does not recognize the product category "cosmeceutical." A product can be a drug, a cosmetic, or both, but the term "cosmeceutical" has no legal meaning. How is a product's intended use determined? Intended use can be determined in several ways. Here are a few examples: - Claims made in product labeling, advertising, the internet, or other promotional materials. Certain claims may cause a product to be considered a drug, even if it is marketed as a cosmetic. Such claims define a product as a drug because its intended use is to treat or prevent disease, or otherwise affect the structure or function of the human body. For example, claims that a product promotes hair growth, reduces cellulite, treats varicose veins, increases or decreases the production of melanin (pigment) in the skin, or regenerates cells. - Consumer perception, which can be determined by the product's reputation. This means asking consumers why they buy the product and what they expect from it. - Certain ingredients cause a product to be considered a drug because they have well-known (to the public and industry) therapeutic uses. For example, fluoride in toothpaste. This principle also applies to "essential oils." For example, a fragrance marketed for the purpose of promoting attractiveness is a cosmetic. But if the fragrance's marketing includes certain "aromatherapy" benefits, such as claiming its scent can help consumers sleep or quit smoking, then due to its intended use, the product meets the definition of a drug. Likewise, a massage oil intended only to lubricate the skin and emit a fragrance is a cosmetic; but if the product's intended use is to treat a condition, such as relieving muscle pain, then it is a drug. How do the laws and regulations for cosmetics and drugs differ? The following information is not a complete description of the laws and regulations for cosmetics or drugs; its purpose is only to alert you to some important differences and similarities between the laws and regulations for cosmetics and drugs regarding approval, good manufacturing practices, registration, and labeling. For questions about drug laws and regulations, you should consult the FDA Center for Drug Evaluation and Research (CDER). How do approval requirements differ? Under the FD&C Act, except for color additives, cosmetic products and their ingredients do not require FDA pre-market approval before going to market. However, drugs generally must obtain FDA pre-market approval through the New Drug Application (NDA) process, or conform to a "monograph" for a specific drug category established by the FDA's over-the-counter (OTC) drug review. These monographs specify the conditions under which OTC drug ingredients are generally recognized as safe and effective (GRASE) and not misbranded. Certain OTC drugs may continue to be marketed without NDA approval until the monograph for their drug category is finalized as a regulation. However, once the FDA makes a final determination on the status of an OTC drug category, such products must either have an approved NDA [FD&C Act, Sections 505(a) and (b)], or conform to the corresponding monograph for OTC drugs. What do these terms mean? - An NDA is the way a drug sponsor formally proposes that the FDA approve a drug for sale and marketing in the United States. The FDA approves an NDA only after determining, for example, that the data are sufficient to show the drug is safe and effective for its intended use and that the benefits outweigh the risks. The NDA system also applies to new ingredients and new indications entering the OTC market for the first time. For example, newer OTC products (previously available only by prescription) must first be approved through the NDA system before being approved to "switch" to OTC status, also through the NDA system. - The FDA has issued monographs or rules for many OTC drug categories. These monographs are published in the Federal Register and specify the requirements for non-prescription drug categories, such as which ingredients may be used and what the intended uses are. The many non-prescription drug categories covered by OTC monographs include: acne medications; medications for dandruff, seborrheic dermatitis, and psoriasis; and sunscreens. You can find relevant information on the FDA 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. Do cosmetics and drugs have different good manufacturing practice requirements? Currently, the FDA has issued the "Draft Guidance for Industry: Cosmetic Good Manufacturing Practices" to help industry and other stakeholders identify standards and issues that may affect the quality of cosmetic products. MoCRA amends the FD&C Act to require the FDA to establish good manufacturing practice (GMP) requirements for facilities that manufacture or process cosmetic products distributed in the United States. Under MoCRA, the FDA must establish these cosmetic GMP regulations by December 29, 2025. The law will require industry to strictly comply with these GMP requirements, with certain exemptions. Cosmetic products that do not meet these GMP requirements will be considered adulterated cosmetics [FD&C Act, Section 601(f)]. These regulations are intended to protect public health and ensure that cosmetic products are not adulterated or misbranded. Regarding drugs, the law requires strict compliance with GMP requirements for drugs, and there are regulations specifying the minimum current GMP requirements for drugs [Code of Federal Regulations (CFR) Title 21, Parts 210 and 211]. Drugs that do not meet GMP requirements will be considered adulterated drugs [FD&C Act, Section 501(a)(2)(B)]. How do registration requirements differ? Under MoCRA, cosmetic product facility registration and cosmetic product listing are now mandatory, with certain exemptions for small businesses. For more information, see "Registration and Listing of Cosmetic Product Facilities and Products." Similarly, drug companies must register their establishments with the FDA and list their drugs [FD&C Act, Section 510; CFR Title 21, Part 207]. See "Drug Registration and Listing System (DRLS and eDRLS)." How do labeling requirements differ? Cosmetic products must be labeled in accordance with cosmetic labeling regulations. For guidance on cosmetic labeling and links to cosmetic labeling-related regulations, see "Cosmetic Labeling." OTC drugs must be labeled in accordance with OTC drug regulations, including the "Drug Facts" labeling described in CFR Title 21, Part 201.66. OTC drug/cosmetic product combinations must use OTC drug/cosmetic combination labeling. For example, drug ingredients must be listed alphabetically as "active ingredients," followed by cosmetic ingredients listed in descending order of their content as "inactive ingredients." What about "soap"? Soap is a category that requires special explanation. This is because the regulatory definition of "soap" differs from the way people commonly use the word. Products that meet the definition of "soap" are not subject to the provisions of the FD&C Act, because - although Section 201(i)(1) of the Act includes "articles... for cleansing" in the definition of cosmetics - Section 201(i)(2) excludes soap from the definition of cosmetics. How does the FDA define "soap"? Not all products marketed as soap meet the FDA's definition of the term. The FDA's interpretation of the word "soap" applies only when: the bulk of the non-volatile 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 marketed only as soap [CFR Title 21, Part 701.20]. Products that meet this definition of soap are regulated by the U.S. Consumer Product Safety Commission (CPSC), not the FDA. For questions about these products (such as safety and labeling requirements), consult the CPSC. If a cleanser does not meet all the criteria for soap... If a product intended to cleanse the human body does not meet all the above soap criteria, then it is a cosmetic or a drug. For example: If the product: consists of detergents, or consists mainly of alkali salts of fatty acids, and is intended not only for cleansing but also for other cosmetic uses, then the product is regulated by cosmetic regulations. Examples of cosmetic uses include making the user more attractive by deodorizing, imparting fragrance to the user, or moisturizing the skin. If the product: consists of detergents, or consists mainly of alkali salts of fatty acids, and is intended not only for cleansing but also for treating, mitigating, or preventing disease, or affecting the structure or any function of the human body, then the product is regulated by drug regulations, or may be regulated by both drug and cosmetic regulations. Examples include antibacterial cleansers and cleansers also used to treat acne. If the product: is intended only for cleansing the human body, has the characteristics consumers generally associate with soap, and its main ingredient is not an alkali salt of fatty acids, then it may be identified as soap on the label, but it is regulated by cosmetic regulations.