According to the federal Food, Drug and Cosmetic Act (FD&C Act), cosmetics are defined as anything “applied to the human body” for the purposes of “cleansing, beautifying, promoting attractiveness, or altering the appearance.” The ingredients used in products that qualify as cosmetics must be individually deemed appropriate for human use by the FDA. However, the individual products that contain these ingredients are not subject to the pre-market approval that drugs and devices require.
In some cases, drugs appear in cosmetics. Active ingredients defined on a cosmetic label are those ingredients classified as drugs, such as a sunscreen agent or hydroquinone. According to the FD&C Act, a drug is “for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” Furthermore, drugs are “intended to affect the structure or any function of the body.”
What about so-called “cosmeceuticals”? Presently, the FDA does not recognize this term, so it doesn’t come into play during review and classification. However, the FDA is starting to pay closer attention to this kind of product, the claims, safety, and whether or not-and how-cosmeceuticals should be regulated.
This does not mean that cosmeceuticals are unsafe; it simply means the FDA needs to decide whether the claims they made about affecting the structure of the body (typically skin) warrant pre-market approval.
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