There have been many misunderstandings relating to the regulation of cosmetic products and OTC drugs in the United States. For the most part, the cosmetic industry has never been directly regulated by any government agency and does not require the FDA to approve a cosmetic/cosmeceutical product prior to marketing. Additionally, in 1972 the FDA initiated a monograph process for OTC drugs which eliminated the need to have premarket approval for certain product categories (sunscreens, antiperspirants, anti-acne, etc.) by companies prior to being sold to consumers. The process of regulation for cosmetics and OTC drugs would appear to be better described as “self-regulated” and, therefore, impacted by various guidelines, legislation, and regulatory bodies as opposed to governed by these entities. Outlined below is a brief review of the laws that are currently in place. A more detailed review can be obtained through other references and/or review of the various regulatory agency Web sites (FDA. gov, FTC. gov, EPA. gov, etc.) (16).
The most important regulations to note are the Food, Drug, and Cosmetic Act of 1938 and the 1960 amendment, the Fair Packaging and Trade Act of 1966 and 1973, the OTC Drug Monograph Process introduced in 1972, and the 1916 Federal Trade Commission Act. With the exception of the latter, which is governed by the FTC, the others are the responsibility of the FDA. Additionally, there have been laws brought about by individual members of the government (Delaney Amendment in 1958—anti-cancer act) as well as by individual state legislatures (California, New York, New Jersey, and Massachusetts, to name a few) which relate to areas such as the Volatile Organic Compounds (VOCs) and the Safe Drinking Water and Toxic Enforcement Act (Proposition 65). Lastly, it should be noted that cosmetic manufacturers are allowed to use any ingredient in a product, as long as the product has been tested and shown to be safe for its intended use, with the exception of hexachlorophene, mercury compounds, chlorofluorocarbon propellants, bithionol, haloge – nated salicylanilides, chloroform, vinyl chloride (aerosol products), zirconium (aerosol products), methylene chloride, acetylethyltetramethyltetralin, musk ambrette, 6-methyl- coumarin, nitrosamines, dioxane, and estrogen.