The Food and Drug Administration (FDA) reportedly regulates $62 billion worth of cosmetics. Cosmetics, Drugs, and Combination Products

This section discusses the Federal Food, Drug, and Cosmetic Act (FFDCA) definitions of cosmetics and drugs, and how the FFDCA differentiates between cosmetics and a cosmetic that also meets the statutory definition of a drug. In addition to the FFDCA, cosmetics are regulated under the Fair Packaging and Labeling Act (FPLA) and related regulations. For example, FDA has regulations on voluntary facility registration and voluntarily reporting for ingredients used in cosmetic products and adverse reactions to cosmetics. Instead, under a voluntary FDA program, cosmetic manufacturers and packagers may report the ingredients used in their product formulations. Finally, FDA does not have mandatory recall authority to require a cosmetic manufacturer to recall a product from the marketplace. However, the agency may request a voluntary recall, and FDA has issued general regulations on the conduct of voluntary recalls that outline the agency's expectations of manufacturers during a recall. While FDA does not have the authority to require compliance with these regulations, FDA may take action against adulterated or misbranded cosmetics. FDA's authority over cosmetics is less comprehensive than its authority over other FDA-regulated products with regard to GMP; premarket notification, clearance, or approval; testing; and mandatory risk labeling. As an example, cosmetic producers are not required to use GMP unless their cosmetics are also drugs. With the exception of color additives, FDA does not require premarket notification, safety testing, or premarket review or approval of the chemicals used in cosmetic products. FDA has issued rules restricting the use of some ingredients in cosmetic products, such as those that it has determined are poisonous or deleterious, which would cause the cosmetic to be adulterated. Additionally, under FFDCA, cosmetics will be deemed to be misbranded, if
the "labeling is false or misleading in any particular"; the label lacks required information; required labeling information is not prominently placed with conspicuousness and "in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use"; the "container is so made, formed, or filled as to be misleading"; use of a color additive does not conform to packaging and labeling requirements; or the packaging or labeling violates the regulations issued under the Poison Prevention Packaging Act of 1970. In contrast, the agency has the authority to order recalls of food, infant formula, medical devices, human tissue products, and tobacco products. Conclusion

Although FDA's authorities over cosmetic products include some of those applicable to other FDA-regulated products, they are generally less comprehensive and exclude certain requirements imposed on other FDA-regulated products. The manner in which a cosmetic product could or should be regulated, however, is not always clear. Nevertheless, some questions remain as to whether the FDA's current oversight of cosmetic products and their ingredients is appropriate. Nor does the agency have the authority to mandate adverse event reports for interactions that consumers experience from the use of a company's products.
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 FDA-regulated 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.