Are all "personal care products" regulated as cosmetics? Are some drugs or "cosmeceuticals"?
People often use the term "personal care products" to refer to a wide variety of items that we commonly find in the health and beauty departments of drug and department stores. These products may fall into a number of different categories under the law.
- Products intended to cleanse or beautify are generally regulated as cosmetics. Some examples are skin moisturizers, perfumes, lipsticks, fingernail polishes, makeup, shampoos, permanent waves, hair colors, toothpastes, and deodorants. These products and their ingredients are not subject to FDA premarket approval, except color additives (other than coal tar hair dyes). Cosmetic companies have a legal responsibility for the safety of their products and ingredients.
- Products intended to treat or prevent disease, or affect the structure or function of the body, are drugs. This is true even if a product affects how you look. Some examples are treatments for dandruff or acne, sunscreen products, antiperspirants, and diaper ointments. Generally, drugs must receive premarket approval by FDA or, if they are nonprescription drugs, conform to special regulations, called "monographs," for their category.
- Some are both cosmetics and drugs. Examples include anti-dandruff shampoos and antiperspirant-deodorants, as well as moisturizers and makeup with SPF (sun protection factor) numbers. They must meet the requirements for both cosmetics and drugs.
- Some may belong to other categories, including medical devices (such as certain hair removal and microdermabrasion devices), dietary supplements (such as vitamin or mineral tablets or capsules), or other consumer products (such as manicure sets).
The law does not recognize any such category as "cosmeceuticals." If a product has drug properties, it must meet the requirements for drugs.
To learn more, see
- Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
- Are Some Cosmetics Promising Too Much?
- FDA Authority Over Cosmetics
- FDA's Cosmetics main page
- Labeling & Label Claims
- Products & Ingredients
- Status of OTC Rulemakings (nonprescription drug monographs)