On Tuesday, March 27, 2012, the House Energy and Commerce’s Subcommittee on Health held the first congressional hearing in 30 years concerning the safety of cosmetics. Subcommittee Chair Joseph R. Pitts, R-Pa., opened the meeting by stating that, recently, industry members have been calling for a national uniform standard for cosmetic ingredients and preemption of state legislation. Chairman Pitts noted that cosmetics differ from other products regulated by the Food and Drug Administration (FDA) such as drugs and devices in that cosmetic products are not subject to premarket approval. Instead, cosmetic manufacturers are largely responsible for substantiating the safety of their products and ingredients before they go to market.
Michael Landa, Director, Center for Food Safety and Applied Nutrition (CFSAN), FDA, provided an overview of FDA’s regulation of cosmetics and then stated that FDA has requested new legislative authority (as part of its FY 2013 budget request) to require cosmetics manufacturers to register with FDA and pay an annual registration fee. According to Mr. Landa, the cosmetic manufacturer user fees would support FDA’s cosmetics safety and other cosmetics-related responsibilities and are estimated to generate $19 million in new resources. In addition, 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. On a separate but related matter, Mr. Landa stated that FDA is developing draft guidance for industry on the Agency’s current thinking on the safety assessment of nanotechnology in cosmetics.
Peter Hutt, General Counsel, Personal Care Products Council (PCPC), stated that Congress can address current regulatory developments facing the cosmetics industry by making changes to the way cosmetics are regulated by FDA. Changes recommended by PCPC include enacting into law FDA programs for registration of manufacturing establishments and listing of cosmetic products, requiring submission of cosmetic-related adverse event reports, and establishing good manufacturing practice requirements for cosmetics. PCPC would also like FDA to utilize the association’s Cosmetic Ingredient Review for determining FDA enforcement, among other things.
Rep. Janice D. Schakowsky, D-Ill., attended the hearing to discuss her cosmetics reform bill, the “Safe Chemicals Act” (HR 2359), which is pending before the Energy and Commerce Committee. The bill would. In part, increase regulation of hazardous chemicals used to manufacture cosmetics. Separately, Dr. Michael DiBartolomeis, California Department of Public Health, stated that no cosmetic product should contain any “carcinogen.”
In summary, the cosmetic industry is facing the prospect of increased regulation by the FDA, especially considering the US cosmetic industry’s chief trade association generally supports mandatory registration and listing of cosmetics, which FDA intends to implement through the establishment of user fees.
To view additional hearing information, click here.