Conference Notebook: ACI’s Cosmetics and Personal Care Products Conference

March 22, 2024By John W.M. Claud

The American Conference Institute’s 11th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products took place this week in New York, and featured a full house of folks talking about the Modernization of Cosmetics Regulation Act (MoCRA), the legal considerations around making environmental, sustainable, and green (ESG) claims, and the impact of state laws. As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance. As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant.

The first panel of the conference discussed upcoming relevant MoCRA deadlines as well as how FDA might develop its monitoring and enforcement system, especially as it relates to safety substantiation. The MoCRA rollout, though, does not preclude that FDA may practice some regulation by enforcement if it deems such action necessary. The Agency’s plans to do so may be affected by FDA’s recent re-organization of its Office of Regulatory Affairs, in addition to the move—for now—of MoCRA oversight from the Center for Food Safety and Nutritional under the Office of Chief Scientist. Such organizational shifts are often motivated by a quest for greater efficiency, but initially the move may be disruptive due to the upheaval of the change.

Panelists also concluded that, in these early days of MoCRA registration and issuance of guidance, organization and preparation are key tools to handling requirements for adverse events (AEs) and recalls. Although much remains to be decided and industry is waiting for guidance from FDA related to some of these issues such as serious adverse event reporting, conference discussions all embraced the development of an appropriate internal company infrastructure to handle new requirements as part of a good faith display of compliance.

In addition to MoCRA, several panels touched on state statutes that regulate chemicals in cosmetics, such as the per- and polyfluoroalkyl substances, known as PFAS. MoCRA requires that FDA issue a report on PFAS in cosmetics by the end of 2025, but one takeaway from these discussions was that several states laws create a patchwork of relevant laws, further complicated by a plaintiffs’ bar that is aggressively pursuing class action lawsuits.

An interesting notice from the conference discussion on PFAS is that, to date, very few if any PFAS class action suits have alleged actual, realized harm from the chemicals. Instead, many of these actions are essentially claim breach of warranty, in which consumers allege that they would not have purchased products at issue if the presence of PFAS had been more clearly noticed. Litigation might include avoiding marketing claims that may trigger suits such as “clean,” “healthy,” “natural,” or “environmentally friendly,” as might be applicable to a particular product. Those claims are often triggers for plaintiff’s litigation if used with products that contain PFAS.

The second day of the conference included a panel that included speakers the Federal Trade Commission and the National Advertising Division of the National Better Business Bureau. That panel reviewed several of the guidelines relating to advertising and marketing practices. Not surprisingly, key takeaways from the panelists echoed guidance from FTC and several recent cases and matters; i.e., provide clear guidance to paid influencers, advise paid influencers to disclose material connections and sponsorships, and clarify when “reviews” are, in fact, marketing. Furthermore, as part of their internal communications about marketing practices, companies are advised that employees who review their own company’s products must disclose their employment.

Thriving in the cosmetics and personal care space requires attention to litigation avoidance strategies and regulatory compliance in addition to more traditional business concerns. Truly, these are complex considerations.

Categories: Cosmetics