CosmeticsDesign recently attended the Food and Drug Law Institute (FDLI)’s educational webinar session which covered “Cosmetic Safety and Contaminants: PFAS, State Versus Federal Regulation, and More.”
The session’s panel was comprised of Emily Gupta, Senior Analyst, Natural Resources and Environment at the U.S Government Accountability Office (GAO), Surya Kundu, Senior Associate, Commercial Litigation at Steptoe LLP, and Xin Tao, Partner at Baker McKenzie, and the panelists came together to “discuss PFAS and other contaminants of concern for cosmetics; FDA’s guidance and GAO’s recommendations, state level initiatives to address cosmetics safety and potential tensions between federal and state law; and potential pathways for improving the overall regulation of cosmetics and alleviating consumer safety concerns,” as detailed on the event’s website.
The panel was moderated by Kelly Bonner, Associate at Duane Morris, LLP, and we had the opportunity to interview Bonner for her insights into the key takeaways from the informational discussion, including an examination of upcoming state legislation with significant potential impact on the cosmetics and personal care product industries, the greatest considerations for cosmetics and personal care product formulators in 2024, and more.
CDU: What would you consider to be the most important or key takeaways from last week’s FDLI Cosmetic Safety and Contaminants: PFAS, State Versus Federal Regulation, and More webinar for manufacturers and suppliers of cosmetics and personal care products in the US?
Kelly Bonner (KB): The most important takeaway, I think, is that the cosmetics industry in the United States is under much greater scrutiny—from federal and state regulators, their customers, social media, and an active and coordinated trial bar. Companies need to be aware of evolving legislation, and taking proactive steps to ensure compliance, and account for an increased risk from costly litigation in a way that is somewhat new for this industry.
CDU: What are the most pressing pieces of state legislation with the greatest potential impact on cosmetics and personal care product manufacturing coming up in the next year in the US, and what should companies in these industries know as they come into enforcement?
KB: Beginning in January 2025, a number of state-level ingredients will come into effect. This includes California’s Toxic Free Cosmetics Act, which prohibits the manufacture and sale of any cosmetic containing a number of intentionally added ingredients, including certain types of parabens, phthalates, 13 PFAS chemicals, and formaldehyde/paraformaldehyde.
California isn’t alone in enacting cosmetic ingredient bans—Maryland, Colorado, and Washington all have bans going into effect January 1, 2025, while other states have bans taking effect in January 2027. But from a practical perspective, California is an enormous market for cosmetics, and it’s unlikely that companies won’t do business in California, or have California-specific formulations.
Companies should be thinking how to reformulate products that contain these ingredients, and what constitutes adequate testing and evaluation methodology to determine whether these ingredients are present or “intentionally added.”
CDU: For companies who currently formulate products with PFAS ingredients, what should their greatest considerations be moving forward into 2024 and beyond?
KB: Apart from the bans, which are increasingly going into effect, and FDA’s forthcoming report on PFAS use in cosmetics and relationship to human health concerns, companies need to be considered about litigation risk. Large scale products liability claims involving personal care products increased in 2023, and are likely to continue to rise over the next few years as plaintiffs allege injuries or a need for medical monitoring resulting from their use of products that contain PFAS.
Additionally, the trial bar is increasingly scrutinizing claims that companies’ products are “clean,” “natural,” “safe” or “nontoxic,” alleging, instead, that they contain PFAS. Typically, these take the form of class action claims are brought under false advertising and other consumer protection statutes such as the NY General Business Law §§ 349-350 or California’s Consumer Legal Remedies Act, and can be expensive and time-consuming to defend.
CDU: What are the best resources for companies with questions regarding any of the topics covered in last week’s webinar?
KB: The FDA’s MoCRA website contains draft and final guidance relating to compliance, and issues regular alerts about upcoming or updated deadlines. And the Personal Care Products Council and Independent Beauty Association have been very active in keeping their members informed about evolving legislation, lobbying efforts on behalf of industry, and what companies need to know about key developments or issues.
CDU: Anything else to add?
KB: That beauty is a dynamic industry—change and innovation are the lifeblood of how beauty companies thrive in competitive markets. And despite regulatory changes, and a changing litigation atmosphere, that doesn’t mean companies should retrench, or stop innovating.
It means that companies need to be proactive about approaching regulatory changes and adjusting to changed circumstances, and they should seek advice from third party consulting firms or outside counsel for questions. And of course, stay current – read, and ask questions.