Warning Letters issued by FDA to firms that marketed hair care products with claims such as restoration of hair growth, hair loss prevention, and treatment of dandruff illustrate an important legal distinction -- the difference between the legal definitions of cosmetics and drugs. Hair growers, hair loss prevention products, and dandruff treatments are considered drugs, not cosmetics, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Cosmetics and drugs are subject to different legal and regulatory requirements. Failure to adhere to requirements for drugs resulted in Warning Letters being issued to the following firms:
For a discussion of the legal differences between cosmetics and drugs, see Is It a Cosmetic, a Drug, or Both? (or Is It Soap?) and Cosmeceuticals.