Competing Cosmetic Safety Bills Would Each Expand FDA Regulatory Authority
On October 25, 2017, Senator Orin Hatch (R-UT) introduced S. 2003, the “FDA Cosmetic Safety and Modernization Act.”1 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).2 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:
- Authorize FDA review of cosmetic ingredient safety. Individual states would be prohibited from regulating cosmetics the agency selects for review. FDA would be required to consult with industry and consumer groups to identify ingredients for review.
- Require cosmetics companies to register manufacturing facilities with the FDA (subject to certain exemptions for small businesses). FDA would also be authorized to suspend a registration (effectively stopping all sales) if it determines that a facility has a reasonable probability of causing a serious adverse health event.
- Broaden the FFDCA’s definition of “adulterated,” by adding that “a cosmetic may be adulterated regardless of whether it is known which particular substance or substances may render the cosmetic injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual.”
- Require FDA to establish “good manufacturing practices” for cosmetics. The agency may not impose standards “for which there is no current and generally available analytical methodology.”
- Authorize FDA to accredit third-party organizations (such as the long-established Cosmetic Ingredient Review funded by the Personal Care Products Council) to assess the safety of cosmetic ingredients and make recommendations to the agency. The organizations may not be affiliated with a government entity or controlled or financed by a cosmetics company.
- Require companies to notify the FDA of any report received about a serious adverse event associated with their cosmetics.
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.”3
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.”4
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.”=5
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:
- Senator Hatch’s bill would authorize chemical safety reviews, but would not impose any associated requirements or timelines on FDA. The Feinstein-Collins bill would require FDA to review five cosmetic ingredients a year.
- The Hatch bill would not authorize cosmetic product recalls.
- Senator Hatch’s bill depends on congressional appropriations for funding. The Feinstein-Collins legislation allows FDA to collect user fees from industry.
- Feinstein-Collins requires FDA to conduct safety chemical reviews, while the Hatch bill would allow third parties to review the chemicals.
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.
1 S. 2003 — 115th Congress: FDA Cosmetic Safety and Modernization Act