Regulatory Controls on Cosmetics

Cosmetics marketed in the United States, whether manufactured domestically or imported from abroad, must be in compliance with the provisions of the FD&C Act, the FPLA, and the regulations published under the authority of these laws. Yet, cosmetics are arguably the least regulated category of articles subject to the jurisdiction of the FD&C Act [16]. There is no premarket approval requirement for cosmetic products or their constituent ingredients under the law. Other than color additives and those few ingredients restricted or prohibited by regulation from use in cosmetics, no mandatory regulatory controls exist on the chemistry and structure substantiation of the ingredients themselves, conditions of manufacture of the finished cosmetic products, or safety testing that the ingredients and products must undergo prior to marketing; no premarket test results need be submitted to the FDA.

The FDA has therefore promulgated regulations and guidance documents to help ensure that only cosmetics that are safe for their intended use and are neither ''adulterated'' nor ''misbranded'' enter interstate commerce. These regulatory documents address the following issues.

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