Autors: Mark N. Duvall, Alan J. Sachs, Michael F. Vitris
Beveridge & Diamond, P.C. , November 28, 2017
On October 25, 2017, Senator Orin Hatch (R-UT) introduced S. 2003 , the “FDA Cosmetic Safety and Modernization Act.”  The proposed legislation would amend the Federal Food, Drug and Cosmetic Act of 1938 (“FFDCA”) and allow the Food and Drug Administration (“FDA”) to regulate finished cosmetic products based on their safety and the safety of their components. Senator Hatch’s legislation presents an alternative to the Personal Care Products Safety Act ( S. 1113 ), a bill reintroduced in May 2017 by Senators Dianne Feinstein (D-California) and Susan Collins (R-Maine).  The Senate referred the bill to the Health, Education, Labor, and Pensions Committee on October 25, 2017.
Cosmetics regulatory reform negotiations will likely continue at least into next year. The Health, Education, Labor and Pensions Committee will consider each of the bills with input from industry and consumer groups. Any bill that passes the Senate will also need to pass the House and be signed by the President before becoming law. Interested stakeholders should closely monitor these legislative developments to evaluate how proposed changes will affect the cosmetics industry.
Congress has not substantively updated requirements for cosmetics under the FFDCA since its original adoption, and the multi-billion dollar cosmetics industry has largely been left to self-regulation. While FDA has some post-market regulatory authority over cosmetic products, the proposed legislation would for the first time require FDA to establish “good manufacturing practices” (GMPs) for the industry and allow the agency to assess the safety of cosmetics ingredients. FDA already has authority to impose GMPs for food, food additives, drugs, and medical devices.
Senator Hatch’s legislation would bring significant changes to cosmetics regulation. Specifically, the bill would:
Senator Hatch’s bill was met with support by the Personal Care Products Council, which praised the senator’s “leadership in introducing legislation to update the regulatory system for the cosmetics and personal care sector,” and described the bill as “an important step forward.” 
Independent Cosmetic Manufacturers and Distributors (“ICMAD”) trade association CEO Pam Busiek stated that the bill “makes important progress in updating federal regulations to give consumers the highest level of confidence in products that are an important part of their daily lives.” But, Ms. Busiek added that “the bill does not yet provide a clear and uniform national standard for ingredient safety review.” 
Scott Faber, Senior Vice President of the Environmental Working Group, criticized the legislation’s preemption provisions and allowance of third-parties to review chemicals in lieu of FDA. Mr. Faber further stated that the bill “would not require the industry to substantiate the safety of its own chemicals, would create a weak and untested safety standard, and would fail to provide the FDA with any resources to oversee a $60 billion industry that impacts the health of every American.” 
While the newly introduced S. 2003 and the earlier Feinstein-Collins bill (S. 1113) would both fundamentally change the regulation of cosmetic products, the competing bills have important differences:
Stakeholders should closely monitor these competing bills’ progress through Congress. If either bill (or compromise legislation) becomes law, cosmetics manufacturers should prepare for FDA rulemaking and increased federal oversight of product ingredients and manufacturing processes.
Beveridge & Diamond’s FDA and Chemicals teams advise clients on product-regulatory issues impacting cosmetics and personal care products. For more information, please contact the authors or any member of our FDA practice group .
 S. 2003 — 115th Congress: FDA Cosmetic Safety and Modernization Act