Consumers Have a Right to Know What is in Their Products: House Panel Focuses on Cosmetics Industry Regulation

On March 27, the House Energy and Commerce Subcommittee on Health held a hearing, “Examining the Current State of Cosmetics.” The hearing focused on the regulatory authority of the Food and Drug Administration (FDA) over the cosmetics industry. As the industry faces new challenges with technology, globalization, and product safety, the hearing addressed implications of legislation that would increase FDA regulation. (See SeniorWomen.com's WalkUp to the Hearings)

In his opening statement, Chair Joe Pitts (R-PA), said, “Cosmetics are regulated by FDA under the Federal Food, Drug, and Cosmetic Act [(FFDCA) P.L. 75-717] of 1938. The FFDCA forbids the introduction of adulterated or misbranded cosmetics into interstate commerce and provides for seizure, criminal penalties, and other enforcement authorities for violations of the act. The Fair Packaging and Labeling Act [P.L. 89-755] also requires cosmetics to carry an ingredient declaration to help consumers make informed purchasing decisions. Unlike other products regulated by FDA, however, such as drugs, medical devices, and biologics, most cosmetic products and ingredients are not subject to FDA premarket approval. Instead, cosmetic manufacturers are largely responsible for substantiating the safety of their products and ingredients before they go to market. Currently, cosmetic facilities can register with FDA on a voluntary basis, but FDA cannot compel them to do so. While FDA has the authority under FFDCA to enter and inspect cosmetic manufacturing facilities, the industry does not pay user fees for this purpose…For the past several years, the industry and members of both parties have been reviewing FDA’s regulatory authority over these products. One issue under review is the need for a national uniform standard for cosmetic products and preemption of state legislation.”

Addressing concern over the safety of cosmetic products in her opening statement, Rep. Jan Schakowsky (D-IL), said, “The fact is this: cosmetics contain ingredients that can cause cancer, mutate cellular structure, and cause reproductive and developmental harm. Industry claims that these ingredients are present at such low doses that they aren’t a problem, but men, women, and children are exposed every day to dozens or hundreds of ingredients in their shampoos, cologne, makeup, lotions, and other products. We have to consider the cumulative effect of exposure. Any bill this committee considers must include – as the Schakowsky/Markey/Baldwin Safe Cosmetics Act [H.R. 2359] does – the following elements: 1) A strong safety standard that bans carcinogens, mutagens, and reproductive toxins; 2) Full ingredient disclosure and labeling. Consumers have a right to know what is in their products; and 3) Mandatory recall authority for the FDA. I think today’s testimony will underscore the need for these provisions, as well as the complexity of this industry and the need for thorough consideration of any legislation making changes to cosmetics regulations.”

Michael Landa, director of the Center for Food Safety and Applied Nutrition at the FDA, said, “The FFDCA defines a cosmetic as an ‘article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting effectiveness, or altering the appearance.’ The definition also includes articles intended for use as a component of any such articles. Cosmetics firms are responsible for substantiating the safety of their products and ingredients before marketing. However, they are not required to submit safety substantiation data to the agency, nor make it available to the agency. Under FFDCA, cosmetic products and ingredients (with the exception of color additives) are not subject to FDA premarket approval or premarket notification.” He continued, “[T]he FY2013 president’s budget request includes new legislative authority for FDA to require domestic and foreign cosmetics manufacturers to register with FDA and pay an annual registration fee. The user fees would support FDA’s cosmetics safety and other cosmetics-related responsibilities and are estimated to generate $19 million in new resources. The product, ingredient, and facility information submitted with registration would expand FDA’s information about the industry and better enable the agency to develop necessary guidance and safety standards. It would also enable the agency to identify and address research gaps, for example, about the safety of novel ingredients. With these additional funding resources, FDA would be able to conduct priority activities that meet public health and industry goals…Overall, the new authority for registration and user fees would strengthen FDA’s ability to protect American consumers from potentially unsafe cosmetic products or ingredients.”

Painting: Jeanne-Antoinette Poisson, Marquise de Pompadour (1721-1764), known as Madame de Pompadour at Her Toilette by François Boucher. From Wikimedia Commons

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Consumers Have a Right to Know What is in Their Products: House Panel Focuses on Cosmetics Industry Regulation

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