The 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, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.
But, if the product is intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, it’s a drug (FD&C Act, 201(g)), or in some cases a medical device (FD&C Act, 201(h)), even if it affects the appearance. Soap and a few other categories also have separate regulation. Other “personal care products” may be regulated as dietary supplements or as consumer products.
Although the FDA does not have the legal authority to approve cosmetics before they go on the market, the law does not take a hands off approach to cosmetics. Under the law, cosmetics must not be “adulterated” or “misbranded.” For example, they must be safe for consumers when used according to directions on the label, or in the customary or expected way, and they must be properly labeled. FDA can take action against a cosmetic on the market if the FDA has reliable information showing that the cosmetic is adulterated or misbranded. Because companies and individuals who market cosmetics bear legal responsibility for the safety and labeling of their products, it is important for those marketing cosmetics to seek advice of an experienced attorney before introducing a product or product labeling into commerce.
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