The Regulatory Interface: When is it a Cosmetic and When a Drug?

Both the cosmetic industry and the Food and Drug Administration (FDA) have had a long and interesting history. FDA’s history began in 1906 with the enactment of the Pure Food and Drug Act. This was the first attempt to regulate the safety of products (or additives). For almost 100 years Congress has set the standards and published them in the United States Code (USC). FDA and other federal agencies promulgate regulations through notice and comment rulemaking. Proposed regulations are published in the Federal Register (FR) and the public is given an opportunity to comment. The agencies then publish in the Federal Register final regulations together with a preamble discussing each comment. Industry and regulatory scientists eagerly follow these changes and access them on the Web. Final regulations are compiled in the Code of Federal Regulations (CFR).

The role of cosmetics is best described in a 1986 speech by former FDA Commissioner Frank Young, M.D., Ph.D., to the Scientific Conference of the Cosmetic, Toiletry and Fragrance Association (CTFA): “Although our first aim in consumer protection has always been product safety, the law also requires us to protect consumers from misbranded Editor’s Note: Jean L. Fourcroy recently retired from many years of service with the FDA. I asked her to give us her thoughts about cosmetics and drugs from the regulatory perspective. Howard I. Maibach, M.D. products. We don’t want to over-regulate; we just want (cosmetic) labels that are free of false and misleading claims (and that) make cosmetic claims, not drug claims. If a label claims to prevent or treat disease or otherwise affect the structure or function of the human body, it is deemed to be a new drug, and the marketer carries the burden of proving it is safe and effective before it can be legally marketed.”

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