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Wonders of the Season
Handbook of U.S. Cosmetic Products Regulations
Handbook of U.S. Cosmetic Products Regulations
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The 1938 Federal Food, Drug, and Cosmetic Act granted the U.S. FDA the authority to regulate cosmetic products and their ingredients, including adulteration and misbranding provisions. In addition to the FD&C Act, cosmetics are regulated under the Fair Packaging and Labeling Act (FPLA) and related regulations. The cosmetics provisions were amended by the Color Additive Amendments Act of 1960 and the Poison Prevention Packaging Act but remain basically the same as the provisions in the 1938 FD&C Act.
FDA's authorities over cosmetic products include some of those applicable to other FDA-regulated products, such as food, drugs and medical devices. Cosmetics are not FDA-approved but are FDA-regulated. Except for color additives, FDA's authority over cosmetics is less comprehensive than its authority over other FDA-regulated products with regard to registration; testing; premarket notification, clearance, or approval; GMP; mandatory risk labeling; adverse event reports; and recalls. For example, FDA does not impose registration requirements on cosmetic manufacturers. As a result, cosmetics are arguably more self-regulated than other FDA-regulated products.
This book provides an overview of cosmetics and the requirements that the FDA verifies/enforces at the time they are marketed or imported into the United States. The FDA's Center for Food Safety and Applied Nutrition (CFSAN) Office of Cosmetics and Colors is responsible for overseeing the cosmetic program.
FDA's authorities over cosmetic products include some of those applicable to other FDA-regulated products, such as food, drugs and medical devices. Cosmetics are not FDA-approved but are FDA-regulated. Except for color additives, FDA's authority over cosmetics is less comprehensive than its authority over other FDA-regulated products with regard to registration; testing; premarket notification, clearance, or approval; GMP; mandatory risk labeling; adverse event reports; and recalls. For example, FDA does not impose registration requirements on cosmetic manufacturers. As a result, cosmetics are arguably more self-regulated than other FDA-regulated products.
This book provides an overview of cosmetics and the requirements that the FDA verifies/enforces at the time they are marketed or imported into the United States. The FDA's Center for Food Safety and Applied Nutrition (CFSAN) Office of Cosmetics and Colors is responsible for overseeing the cosmetic program.
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