Congress Considering Legislation Giving FDA Additional Regulatory Authority Over Cosmetics and Personal Care Products

In April 2015, Senator Diane Feinstein (D-CA) and Senator Susan Collins (R-ME) introduced the Personal Care Products Safety Act (S. 1014). In her Senate floor remarks, Senator Feinstein said that she and Senator Collins “have been working with consumer groups, companies, and FDA to put together a bipartisan, middle of the road bill to update the regulatory structure for personal care products, provide a streamlined national system of oversight and accountability, and review the safety of specific chemicals in these products.”
 
Under the Feinstein-Collins bill:

• FDA will be required to evaluate at least five ingredients per year to determine their safety and appropriate use;
• FDA will have the authority to recall products threatening consumer safety and require labeling of some products;
• Manufacturers will be required to provide contact information to consumers, to report serious adverse effects to FDA, to register annually with FDA, and to provide FDA with a list of ingredients used in their products;
• FDA will be required to issue regulations on Good Manufacturing Practices for personal care products;
• States will be preempted from issuing their own regulations, but laws and regulations in states that have already done so, notably California, will be grandfathered; and
• FDA is authorized to collect user fees.

The cosmetics industry is divided on the Feinstein-Collins bill. The Personal Care Products Council said it supports “the creation of a national standard that maintains the continued safety of our products while providing the U.S. Food and Drug Administration (FDA) with additional regulatory authority over our industry.” The PCPC noted that “the current patchwork regulatory approach with varying state bills” hurts consumer confidence and impedes the industry’s ability to innovate.

In contrast, the Independent Cosmetic Manufacturers and Distributors has stated that it opposes Feinstein-Collins because it “place[s] too large a burden on small business” and does not “provide reasonable national uniformity.” ICMAD instead supports the Safe Cosmetics Modernization Act (H.R. 4075), introduced in November 2015 by House Rules Committee Chairman Pete Sessions (R-TX). ICMAD said the Sessions bill would “significantly enhance the FDA’s oversight of cosmetics and cosmetic safety” but with “complete national uniformity,” superior to the pre-emption in the Feinstein-Collins bill.

Similarly, reaction from environmental, health, and consumer organizations has been mixed. Last week, a group of personal care product manufacturers and health and consumer organizations urged the Senate to “quickly move” the Feinstein-Collins bill—an indication of a renewed push forward. Among the supporters of the Feinstein/Collins bill are the Environmental Working Group, the Society for Women’s Health Research, HealthyWomen, the March of Dimes, and National Alliance for Hispanic Health.

On the other hand, the Campaign for Safe Cosmetics, although praising Senators Feinstein and Collins for their leadership, said that the bill needs stronger safety standards, a more robust industry safety self-certification process, better disclosure of ingredients, required data sharing, and a right-to-know provision for adverse reactions. CSC also demanded complete removal of any federal preemption, which is a key goal for industry stakeholders who are unlikely to support any bill that does not include preemption.

In late August, Rep. Frank Pallone (D-NJ), the senior Democrat on House Energy and Commerce, asked that the Chair of the Committee, Fred Upton (R-MI), schedule a hearing to examine the regulatory framework for cosmetics as a step toward “bring[ing] cosmetic regulation into the 21st Century.” Rep. Pallone introduced FDA cosmetics legislation in 2012 (H.R. 4262) and may do so again in the coming weeks.

We expect continued activity in both the Senate and House on this issue during the short pre-election session beginning this week, and a potential (but not yet certain) post-election “Lame Duck” session. However, in light of the competing approaches in the Feinstein-Collins and Sessions bills, opposition from at least one consumer group, and the short time remaining in this Congress, it is unclear whether Congress and the President will come to agreement and complete action this year on cosmetics and personal care products legislation. Instead, activity this year may lay the groundwork for action by the next Congress.

*Update: On September 14, Rep. Pallone, joined by Rep. Leonard Lance (R-NJ), released a discussion draft of legislation to “strengthen the Food and Drug Administration’s (FDA) authority to regulate cosmetic products.”

*Update: On September 22, the Senate Health, Education, Labor & Pensions Committee (HELP) held a hearing on the Feinstein-Collins bill.