The Business of Beauty | Regulatory Insight

Regulatory Insight: FDAs Authority of Cosmetics : Q&A

Public Policy and External Affairs | March 2012
What is FDA's authority over cosmetics? What are "cosmeceuticals"?

FDA's legal authority over cosmetics is different from other products. Cosmetic products and ingredients are not subject to FDA premarket approval with the exception of color additives. The FDA may take regulatory action if it has information that a cosmetic has been adulterated or misbranded.
Are all personal care products regulated as cosmetics?

While the Food, Drug, and Cosmetic Act (FD&C Act ) does not recognize the term "cosmeceutical," the cosmetic industry has begun to use this word to refer to cosmetic products that have drug-like benefits. While drugs are subject to an intensive review and approval process by FDA, cosmetics are not approved by FDA prior to sale. If a product has drug properties, it must be approved as a drug.
Does FDA require animal testing for cosmetics?

What ingredients are prohibited from use in cosmetics?

With the exception of color additives and a few prohibited ingredients, a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient.. FD&C Act requires that color additives used in cosmetics must be tested for safety and be listed by the FDA for their intended uses. Regulations restrict or prohibit the use of the following ingredients in cosmetics: bithionol, mercury compounds, vinyl chloride, halogenated salicyanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbon propellants and hexachlorophene. In addition to the ingredients that are controlled by regulation or subject of a court ruling, cosmetic and fragrance trade associations have recommended eliminating or limiting the use of certain ingredients associated with health risks.
What does the law say about cosmetic safety and labeling?

Under the law only some of the products commonly referred to as "personal care products" are cosmetics. These include, for example, skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants. Some, however, are regulated as drugs. Among these are skin protectants such as lip balms, mouthwashes marketed with therapeutic claims, antiperspirants, and treatments for dandruff or acne. Generally, drugs must either receive premarket approval by FDA or conform to final regulations specifying conditions whereby they are generally recognized as safe and effective, and not misbranded. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing.

The FD&C Act does not specifically require the use of animals in testing cosmetics for safety. The agency consistently advises cosmetic manufacturers to employ testing methods that are appropriate and effective for substantiating the safety of their products. It is the responsibility of the manufacturer to ensure the safety of both ingredients and finished cosmetic products prior to marketing. Animal testing by manufacturers seeking to market new products may be used to establish product safety. In some cases, after considering available alternatives, companies may determine that animal testing is necessary to assure the safety of a product or ingredient. The agency does support the development and use of alternatives to whole-animal testing when animals are used for testing the safety of their products.

The two most important laws pertaining to cosmetics marketed in the United States are the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics. Violations of the Act involving product composition are subject to regulatory action.

Under the FPLA, the FDA requires an ingredient declaration to enable consumers to make informed purchasing decisions. Cosmetics that fail to comply with the FPLA are considered misbranded under the FD&C Act. A change in FDA's statutory authority over cosmetics would require Congress to change the law.
Who is responsible for substantiating the safety of cosmetics?

restraining order against the manufacturer or distributor, cosmetics may be subject to seizure., and the FDA may initiate criminal action against a person violating the law.
Can FDA inspect cosmetic manufacturers?

The Facts

The FDA can and does inspect cosmetic manufacturing facilities under the FD&C Act or FPLA.
Does FDA test cosmetics?

Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing. Failure to adequately ensure the safety of a cosmetic product or its ingredients prior to marketing causes the product to be misbranded unless a warning statement appears on the principal display panel of the product's label.
Can FDA order the recall of a hazardous cosmetic from the market?

The FDA does collect samples for examination and analysis as part of its plant inspections, import inspections, follow-up to complaints of adverse reactions, and may research cosmetic products and ingredients to address safety concerns. The agency does not function as a private testing laboratory.
Must cosmetic manufacturers register with FDA?

Recalls of cosmetics are voluntary actions taken by manufacturers or distributors. The FDA categorizes a firm's action as a recall when it determines that the product hazard or defect represents a violation of the FD&C Act. The FDA is not authorized to require recalls of cosmetics but does monitor companies that conduct a product recall and may request a product recall if the firm is not willing to remove the product from the market.
What actions can FDA take against firms that market adulterated or misbranded cosmetics?

Manufacturers are not required to register their cosmetic establishments, file data on ingredients, or report cosmetic-related injuries to FDA. Companies are encouraged to register their establishments and file Cosmetic Product Ingredient Statements with FDA's Voluntary Cosmetic Registration Program (VCRP).

Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. FDA may take regulatory action if it has information to support that a cosmetic is adulterated or misbranded.The agency can pursue action through the Department of Justice in the federal court system to remove adulterated and misbranded cosmetics from the market The agency has advised cosmetic manufacturers to employ whatever testing is appropriate and effective for substantiating the safety of their products. FDA supports the development and use of alternatives to whole-animal testing as well as adherence to the most humane methods available The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics With the exception of color additives and a few prohibited ingredients, a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient FDA is not authorized to require recalls of cosmetics but does monitor companies that conduct a product recall FDA can and does inspect cosmetic manufacturing facilities to ensure product safety

---------------------------------------------------References

FDA may take regulatory action if it has information to support that a cosmetic is adulterated or misbranded. The agency can pursue action through the Department of Justice in the federal court system to remove the cosmetics from the market. To prevent further shipment they may request a federal district court to issue a

Information courtesy and adapted from FDA Cosmetics. The Business of Beauty www.thebusinessofbeauty.blog.com