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Monday, July 16, 2012

FDA Regulation of Cosmetics and Personal Care Products

Amalia K. Corby-Edwards
Analyst in Public Health and Epidemiology

The 1938 Federal Food, Drug, and Cosmetic Act (FFDCA) granted the Food and Drug Administration (FDA) the authority to regulate cosmetic products and their ingredients. The statutory provisions of the FFDCA that address cosmetics include adulteration and misbranding provisions. In addition to the FFDCA, 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 FFDCA.

FDA’s authorities over cosmetic products include some of those applicable to other FDAregulated products, such as food, drugs, medical devices, and tobacco. For example, FDA has the authority to take certain enforcement actions—such as seizures, injunctions, and criminal penalties—against adulterated or misbranded cosmetics. Additionally, as with drug and food companies, FDA may conduct inspections of cosmetic manufacturers and prohibit imports of cosmetics that violate the FFDCA. The agency also has issued rules restricting the use of ingredients that the agency has determined are poisonous or deleterious.

However, 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; good manufacturing practices; mandatory risk labeling; adverse event reports; and recalls. For example, FDA does not impose registration requirements on cosmetic manufacturers. Rather, cosmetic manufacturers may decide to comply with voluntary FDA regulations on registration. With the exception of color additives, FDA does not require premarket notification, safety testing, review, or approval of the chemicals used in cosmetic products. Cosmetic manufacturers also are not required to use good manufacturing practices (GMP)—although FDA has released GMP guidelines for cosmetic manufacturers—nor required to file ingredient information with, or report adverse reactions to, the agency. Instead, under a voluntary FDA program, cosmetic manufacturers and packagers may report the ingredients used in their product formulations. FDA does not have the authority to require a manufacturer to recall a cosmetic product from the marketplace, although the agency has issued general regulations on voluntary recalls. The agency’s ability to issue regulations on cosmetic products is limited by the agency’s statutory authorities or lack thereof.

As a result, cosmetics are arguably more self-regulated than other FDA-regulated products. The manner in which a cosmetic product could or should be regulated, however, is not always clear. FDA’s guidelines have provided the cosmetic industry with considerable flexibility for product development and claims. The question remains as to whether that flexibility and the extent of government oversight of cosmetic products are still appropriate.

Date of Report: July 9, 2012
Number of Pages: 43
Order Number: R42594
Price: $29.95

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