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FDA Definitions of “Cosmetic” and “Drug”

FDA Director, Office of Cosmetics and Colors, Linda Katz issued a recent statement clarifying the FDA position on the definitions “cosmetic” and “drug” and provides detailed information about which types of marketing claims are proper used for cosmetics and which are allowed only for drugs. This is important information for cosmetic marketers to understand. Inadvertently using drug claims on cosmetic product label may cause the FDA to declare the cosmetic as a “misbrand drug.” The FDA is becoming increasingly concerned due to escalation in what they term “claim creep”; the tendency for some marketers to make cosmetic claims which are increasingly “drug-like.” Dr. Katz’s update can help marketers better understand the FDA position and may help avoid an FDA warning letter or other regulatory action. Click here to read the FDA Editorial