On March 5, 2019, FDA Commissioner Scott Gottlieb, M.D. and FDA/CFSAN Director, Susan Mayne, Ph.D., released new independent test results confirming asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers. The agency also issued a safety alert warning consumers not to use the cosmetic products sold by Claire’s that had tested positive for asbestos that, at the time, had yet to be recalled. FDA announced a voluntary recall on March 12th.
The FDA statement issued in conjunction with these actions stressed the importance of cosmetic safety and key challenges presented by the cosmetic provisions of the federal Food, Drug and Cosmetic Act (FDCA). The FDA noted that the provisions, which have not been updated since the law was enacted in 1938, do not require cosmetic manufacturers to test their products for safety. Thus, the agency called on the cosmetic industry to do more to ensure product safety, noting that FDA has “only limited tools” regarding cosmetics and is “dependent on manufacturers” that “bear critical responsibilities” related to product safety.
The FDA statement laid out a number of steps the agency is taking “to reinforce the obligations of manufacturers” to ensure the safety of the cosmetic products they market. As FDA determines further steps it should take to protect consumers, the agency has identified a few action items to better understand the cosmetic industry:
- Working “with cosmetics manufacturers and requesting information about what procedures they use to ensure their cosmetics are safe” and that “talc used in any cosmetic product is free from asbestos”;
- Investigating how manufacturers source talc with appropriate traceability, and whether they test raw talc and/or their finished products;
- Determining how many cosmetics products contain talc; and
- Evaluating whether manufacturers have received adverse event reports associated with talc-containing products.
- FDA also expressed a commitment to take other actions based on the agency’s existing authority under the FDCA “by leveraging [such] authorities to the greatest extent.” This includes:
- Making determinations if certain cosmetic ingredients should be prohibited or restricted;
- Testing products made with talc and taking the necessary regulatory and enforcement actions; and
- Creating an interagency working group to propose draft standards to improve consistency for talc testing.
In addition, the FDA statement calls upon cosmetic firms to take the following voluntary actions, which are not currently required under the FDCA for cosmetic products manufacturers:
- Register cosmetic products and list ingredients, including talc, that are used in their cosmetic products with the Voluntary Cosmetic Registration Program; and
- Proactively report adverse events involving cosmetic products to the CFSAN’s Adverse Event Reporting System.
The statement suggests that the current “outdated” FDCA cosmetic framework, and the limited resources available for FDA’s cosmetic programs, are impediments to ensuring cosmetic safety and consumer protection. To remedy this, the agency proposes working with stakeholders and Congress to “modernize” the scope of FDA’s cosmetic authority in light of “the industry’s significant expansion.” Potential legislative action may have elements that resemble the FDA Food Safety Modernization Act (FSMA), enacted in 2011, and other FDCA provisions that currently apply to foods. As FDA explained:
To improve consumer safety and secure our mission for years to come, a more modern approach could include tools that are tailored for cosmetics, including appropriate frameworks for registration and listing of products and their ingredients, good manufacturing practice regulations, company reporting of adverse events, access to records (including consumer complaints) during routine or for-cause inspections, mandatory recalls, disclosure of known cosmetic allergens on a product’s label, and ingredient review.
FDA’s actions have been met with congressional approval as at least one congressman has indicated that legislative action may already be in the works. On March 5, 2019, Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) released a statement commending FDA’s commitment to ensuring the safety of cosmetics noting:
Every day millions of Americans assume the cosmetics they use are safe, but unfortunately that is not always the case. The reality is that cosmetics are one of the least regulated consumer products on the market and FDA acknowledged today that the agency does not have the necessary authority to oversee the industry. . . . Unfortunately, FDA does not currently have the authority to mandate a recall on the products. Examples like Claire’s refusal to voluntarily recall their asbestos-tainted products demonstrates the need to modernize the current regulatory framework for cosmetic and personal care products to ensure that FDA can act to protect consumers when industry fails to do so. That is why I have already begun the process of circulating a bipartisan discussion draft on a proposal to update our laws for the first time in over eighty years.
On March 7, 2019, Senators Feinstein (D-CA) and Collins (R-ME) introduced a co-sponsored bill entitled, the “Personal Care Products Safety Act.” The bill is designed to expand FDA’s authority to regulate personal care products, including by authorizing FDA to: review the safety of at least five cosmetic ingredients annually; recall unsafe products; establish new labeling requirements; establish adverse event reporting requirements; and require companies to register with FDA annually and provide the agency with information concerning their products’ ingredients. The bill would also direct FDA to issue Good Manufacturing Practices regulations and authorize the agencies to collect user fees from product manufacturers to fund these activities. A number of companies and health and consumer organizations support the bill.
FDA’s recent announcement indicates it recognizes the growth of the cosmetic industry and is subsequently seeking ways to increase its regulatory oversight. We will continue to keep you posted with any updates in this space.