Standards and Regulations

Whether a product is legally classified as a cosmetic or a drug depends on its intended use. Different laws and regulations apply to different types of products. Companies sometimes violate the law by marketing cosmetics as if they have drug properties, or by marketing drugs as cosmetics without complying with the requirements for drugs.

How does the law define cosmetics?

Federal Food, Drug, and Cosmetic Act (FD&C Act)The FD&C Act defines cosmetics as articles “intended to be rubbed, poured, sprinkled, or applied to the human body, or otherwise used on the human body…to cleanse, beautify, enhance the attractiveness, or alter the appearance” [Section 201(i) of the FD&C Act]. Products covered by this definition include: skin moisturizers, perfumes, lipsticks, nail polishes, makeup products, cleansing shampoos, perms, hair dyes, and deodorants, as well as any substance intended for use as an ingredient in a cosmetic product.

The Cosmetics Regulatory Modernization Act of 2022 (MoCRA) amended the FD&C Act to include a definition of “cosmetic product” as “a preparation of cosmetic ingredients of a qualitatively and quantitatively defined composition intended for use in a finished product” [Section 361 of the FD&C Act]. This new terminology applies to these amended provisions of the FD&C Act.

How is medicine defined under the law? 

The FD&C Act defines drugs in part based on 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 human body or other animals” [Section 201(g)(1) of the FD&C Act].

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

Some products meet the definitions of both a cosmetic and a drug. This may be the case if the product has more than one intended use. For example, Anti-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.Examples of product/drug combinations include toothpaste containing fluoride and advertised as freshening breath and cleaning teeth; deodorants that also act as antiperspirants; and moisturizers and cosmetics advertised as sunscreen. These products must meet the requirements of both cosmetics and drugs.

What are “cosmeceuticals”?

The FD&C Act does not recognize products called "cosmeceuticals." A product can be a drug, a cosmetic, or both, but the term "cosmeceutical" has no legal meaning.

How to determine the intended use of a product?

Intended use can be determined in a variety of ways. Here are a few examples:

• Claims of efficacy made on product labels, in advertising, on the internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if it is marketed as a cosmetic. These claims qualify 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. Examples include claims that a product can promote hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin (pigment) in the skin, or regenerate cells.

• Consumer perception, which can be determined through the product’s reputation. This means asking consumers why they buy the product and what they expect from it.

• Some ingredients have well-known (to the public and industry) therapeutic uses that result in the product being considered a drug. For example, fluoride in toothpaste.

This principle also applies to"Essential oils." For example, a perfume marketed to enhance attractiveness is a cosmetic. However, if the perfume's marketing claims include certain "aromatherapy" benefits, such as claiming that its scent can help consumers sleep or quit smoking, then the product meets the definition of a drug due to its intended use. Similarly, a massage oil intended solely for lubrication and fragrance is a cosmetic; however, if the product's intended use is to treat a medical condition, such as relieving muscle pain, it is a drug.

How do the laws and regulations for cosmetics and pharmaceuticals differ?

The following information is not a complete description of cosmetic or pharmaceutical laws and regulations; it is intended only to draw your attention to some important differences and similarities between cosmetic and pharmaceutical laws and regulations regarding approval, good manufacturing practices, registration, and labeling. For example, you should consult FDA Center for Drug Evaluation and Research (CDER).

How are the approval requirements different?

according to Under the FD&C Act, cosmetic products and their ingredients, with the exception of colorants, are not subject to FDA approval before marketing. However, drug products generally must receive FDA premarket approval through the New Drug Application (NDA) process or comply with a "monograph" for a specific drug category developed by the FDA's over-the-counter (OTC) drug review agency. These monographs define the conditions under which OTC drug ingredients must be generally recognized as safe and effective (GRASE) and not falsely advertised. Some OTC drug products can continue to be marketed without an NDA until the monograph for their drug category is finalized as regulation. However, once the FDA makes a final determination regarding the status of an OTC drug category, such products must either receive an approved NDA [sections 505(a) and (b) of the FD&C Act] or comply with the appropriate monograph for the OTC drug category.

What do these terms mean?

• An NDA is the pathway by which a drug sponsor formally proposes to the FDA for approval to sell and market a drug in the United States. The FDA approves an NDA only after, for example, determining that the data are sufficient to demonstrate that the drug is safe and effective for its intended use and that its benefits outweigh its risks. The NDA system also applies to new ingredients and 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 allowed to "convert" to OTC status, which also requires an NDA.

• The FDA has issued monographs, or rules, for many categories of OTC drugs. These monographs, published in the Federal Register, set requirements for categories of over-the-counter drugs, such as what ingredients can be used and what the intended use is. The many categories of over-the-counter drugs covered by OTC monographs include:

o Acne medications

o Medications for dandruff, seborrheic dermatitis, and psoriasis

Sunscreen

You can Find relevant information on the FDA website under “Development and Approval Process (Drugs),” specifically “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 pharmaceuticals have different good manufacturing practice requirements?

at present,The FDA has published a draft guidance for industry, "Cosmetic Good Manufacturing Practice," to help industry and other stakeholders identify standards and issues that may impact the quality of cosmetic products. MoCRA amended the FD&C Act to require the FDA to establish good manufacturing practice (GMP) requirements for facilities that manufacture or process cosmetic products for distribution in the United States. Under MoCRA, the FDA must develop these cosmetic GMP regulations by December 29, 2025. The law will require industry to strictly adhere to these GMP requirements, with certain exemptions. Cosmetic products that fail to meet these GMP requirements will be considered adulterated cosmetics [section 601(f) of the FD&C Act]. These regulations are intended to protect public health and ensure that cosmetic products are not adulterated or falsely advertised.

Regarding medicines, the law requires strict compliance with GMP requirements exist, and regulations set forth the minimum current GMP requirements for drugs [21 CFR parts 210 and 211]. Drugs that do not comply with GMP requirements are considered adulterated [section 501(a)(2)(B) of the FD&C Act].

How are the registration requirements different? 

according to Under MoCRA, registration of cosmetic product facilities and listing of cosmetic product products 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 facilities and list their drugs with FDA [section 510 of the FD&C Act; 21 CFR part 207]. See "Drug Registration and Listing System (DRLS and eDRLS)."

How are labeling requirements different?

Cosmetic products must be labeled in accordance with the Cosmetic Labeling Regulations. For guidance on cosmetic labeling and links to the regulations governing cosmetic labeling, See also"Cosmetic Labels".

OTC drugs must be labeled according to OTC drug regulations, including the "Drug Facts" labeling described in 21 CFR Part 201.66. OTC drug/cosmetic combination products 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 concentration, as "Inactive Ingredients."

in the case ofWhat about "soap"?

Soap is a category that requires special explanation. This is becauseThe regulatory definition of “soap” differs from how 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 qualify as FDA Definition of the Term. FDA interprets the term "soap" to apply only to the following:

• The majority of the non-volatile matter in the product consists of alkali metal salts of fatty acids, and the detergency of the product is attributed to the alkali-fatty acid compounds, and

• This product is labeled, sold, and advertised solely as soap [21 CFR Part 701.20]. Products that meet this definition of soap are regulated by the U.S. Consumer Product Safety Commission (CPSC), not the FDA. Questions about these products, such as safety and labeling requirements, should be directed to the CPSC.

If a detergent doesn't meet all the criteria for soap……

If a product intended for cleansing the human body does not meet all of the above criteria for soap, then it is either a cosmetic or a drug. For example:

If the product:

• consists of detergent, or

• Consists primarily of alkali metal salts of fatty acids, and

• Not only for cleaning, but also for other cosmetic purposes,

Examples of cosmetic uses include making the user more attractive by removing odor, giving the user a scent, or moisturizing the skin.

If the product:

• consists of detergent, or

• Consists primarily of alkali metal salts of fatty acids, and

• If a product is intended not only for cleansing but also for the treatment, cure or prevention of disease, or to affect the structure or any function of the human body, then the product is regulated under the Medicines Regulations, or may be regulated under both the Medicines and Cosmetics Regulations. Examples include antibacterial cleansers and cleansers that are also used to treat acne.

If the product:

• For cleaning of the human body only,

• possess the properties that consumers typically associate with soap, and

• The main component is not an alkali metal salt of a fatty acid,

It can be labeled as soap, but it will be regulated under the Cosmetics Regulations.