Understanding the Evolving Regulatory Landscape

Talc-Containing Products: On April 5, 2024, the US Food and Drug Administration (FDA) confirmed that its recent third-party testing of talc-containing cosmetic products identified no traces of asbestos in any of the 50 cosmetic samples analyzed, marking the third consecutive year of asbestos-free talc products in the United States. This testing is part of ongoing efforts where the agency selects cosmetic products for testing based on various criteria, including product type, popularity, marketing strategies, and potential third-party reports of asbestos contamination. Although this news is reassuring for the industry, the legal landscape is still fraught with litigation. As part of MoCRA, U.S. Congress directed the FDA to issue a proposed rule on standardizing testing methods for detecting and identifying asbestos in talc-containing cosmetics.

The FDA sent its proposed rule for review to the U.S. Office of Management and Budget in early January 2024, and pursuant to MoCRA, is expected to issue a final rule 180 days after the close of the public comment period. The FDA intends to promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.

PFAS in Cosmetics: Per- and polyfluoroalkyl substances (PFAS) — a group of man-made chemicals often used for their conditioning properties — have come under fire due to their environmental persistence and potential health risks. Recognizing the importance of this issue, MoCRA directs the FDA to assess the use and safety of PFAS in cosmetic products and publish a report summarizing its findings by December 29, 2025.

Fragrance Allergen Labeling: Under MoCRA, the FDA must issue a rule on fragrance allergen labeling as a way to enhance transparency and enable consumers (particularly those with allergies and other sensitivities) to make informed decisions. As part of this rulemaking, the FDA is expected to identify specific allergens that require disclosure and establish thresholds for when these allergens must be declared on product labels. Although MoCRA’s deadline was June 29, 2024, the FDA has yet to issue a proposed rule. Once it does, there will be a period for public comment and industry feedback, an important part of the process that ensures stakeholder engagement when developing critical safety standards.

Good Manufacturing Practices: MoCRA recognizes the importance of standardized manufacturing and operating processes across the cosmetics industry. Good Manufacturing Practices (GMPs) are intended to ensure product consistency, safety, and quality, thereby minimizing contamination risks and enhancing overall product integrity. By the end of 2025, after a year-long proposal and review process, MoCRA requires the FDA to establish GMPs for cosmetics sold in the U.S. Once established, these practices will be mandatory, covering all aspects of production, from raw material receipt to final product distribution.

Appreciating Potential Litigation Risks

As the industry awaits further guidance from the FDA on these important issues, cosmetic companies must keep in mind the legal risks of noncompliance. As regulations tighten, the likelihood of litigation increases for companies that fall behind and fail to adhere to the following new standards:

• Product Liability: If a cosmetic product is not manufactured according to applicable GMPs, is formulated using prohibited substances, or contains ingredients at concentrations in excess of permitted levels, companies involved in the manufacture, distribution, and sale of that product could face lawsuits (including class action lawsuits) asserting various tort claims, including for fraud, negligence, and strict product liability, and alleging various harms ranging from personal injury to economic loss.
• False and Misleading Advertising: Under MoCRA, all cosmetic products sold in the United States will need to contain labels with, among other things, the identity of any fragrance allergens. Companies that fail to accurately label cosmetic products or make false claims about the safety or ingredients of those products could lead to lawsuits (including class action lawsuits) by consumers for false and misleading labeling or packaging, alleging various harms ranging from personal injury to economic loss.

Of course, the consequences of noncompliance are not limited to consumer-facing litigation. Companies that fail to comply with MoCRA’s various requirements may face regulatory actions, fines, and other penalties — all of which can cause irreparable harm to company finances and brand reputation.

The beauty industry is bracing for change, and it is difficult to predict how FDA enforcement of MoCRA will play out. In light of this uncertainty, it is critical for companies to understand the nuances of these upcoming regulatory developments and to remain mindful of what can happen if they do not.

About the Authors

Marcha Isabelle Chaudry is the founder of the Equity and Wellness Collaborative (EWC), which specializes in comprehensive compliance management, offering tailored solutions that ensure brands meet regulatory requirements efficiently. By focusing on areas such as facility registration, product listing, adverse event reporting, label compliance, and safety assessments, EWC equips businesses with the tools and knowledge needed for seamless MoCRA compliance.

Rachel Raphael is a partner at Morgan, Lewis & Bockius LLP. Rachel regularly defends clients against claims of unfair business practices and false advertising. She also advises consumer products, personal care, and cosmetics companies on the many issues that may arise over the product life cycle. As a litigator and regulatory counselor, Rachel offers insights on how to mitigate the legal risks associated with MoCRA compliance.

The opinions expressed are those of the authors and do not necessarily reflect the views of their firms or clients. This article is for general information purposes and is not intended to be, and should not be taken as, legal advice.