In December 2022, President Biden signed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). As previously covered by CosmeticsDesign earlier this month, MoCRA is the first update to cosmetic law in eighty-five years and grants the FDA new authority and oversight in different areas of cosmetics product regulation.
To better understand the reaction from the legal community representing the cosmetics and personal beauty care industries, CosmeticsDesign sat down with attorneys Kristine Kruger and Tommy Tobin of Perkins Coie LLC for their perspective and commentary on the impact of the impending law.
CDU: How did you initially react to the news when MoCRA was signed into law last month?
Kristine Kruger, Senior Counsel at Perkins Coie LLP: MoCRA represents the most significant expansion of FDA authority over cosmetics since 1938. This new law will have ramifications for the cosmetics industry now and in the years to come.
It is also important to understand that several provisions of MoCRA will develop in the coming years as the FDA issues required reports and new regulatory proposals, such as those requiring Good Manufacturing Practices (GMPs) for the cosmetics industry. The cosmetics industry will have an opportunity to comment on forthcoming FDA rules implementing MoCRA as part of the regulatory process.
CDU: What are you most excited about when considering the changes MoCRA will make to the federal oversight of cosmetics and beauty products?
Tommy Tobin, Associate at Perkins Coie LLP: One of the most important aspects of MoCRA is that the FDA will now have mandatory recall authority over cosmetic products. Previously, the agency could not order a mandatory recall of cosmetics.
As the FDA explained in March 2022 guidance, “FDA has no authority under the [Federal Food, Drug, & Cosmetic Act] to order a recall of a cosmetic, although it can request that a firm recall a product.”
Now, under MoCRA, the FDA can order a mandatory recall of cosmetics after it makes three specific findings:
(1) the cosmetic product is adulterated or misbranded,
(2) the use of or exposure to the cosmetic will cause serious adverse health consequences or death, and
(3) the responsible entity has refused to voluntarily cease distribution and/or recall the cosmetic product.
This new authority provides the FDA with additional enforcement tools to monitor and police the cosmetics market, and the industry should take note to understand the recall process and prepare to address issues if they occur.
CDU: Does anything give you pause about the new law as it comes into effect?
Kruger: Among other things, MoCRA provides reporting requirements for the FDA to issue a report regarding the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetics and the scientific evidence related to the safety and risks associated with the use of PFAS in cosmetics. The state of the science regarding PFAS is still developing.
As my colleagues and I have noted elsewhere, the plaintiffs’ bar is now filing class action matters targeting companies for even trace amounts of PFAS, when it is unsettled whether such substances actually pose any actual health risks or would be misleading to a reasonable consumer. Ideally, the FDA report would accurately reflect the state of the science and allow meaningful opportunities for stakeholders to contribute in the development of the report.
CDU: What do you think will be MoCRA’s biggest impact on the industry overall?
Tobin: Much of the cosmetics industry supported MoCRA’s passage, and this law has been in the works for several years. With that in mind, the most important impact to the industry will be the FDA’s increased authority over cosmetic products.
MoCRA brings cosmetics regulation in closer alignment to the other products regulated by the FDA, namely foods, dietary supplements, and over-the-counter drugs. For example, cosmetics companies will now have reporting and record-keeping requirements for serious adverse events associated with the cosmetic products.
CDU: In the coming months, what is/are the biggest challenge(s) for companies in the skincare, cosmetics, and beauty industries because of MoCRA?
Tobin: Cosmetic companies should be aware of new and potentially forthcoming regulatory compliance obligations as a result of MoCRA’s passage. While the effective date for many of MoCRA’s provisions is December 29, 2023, preparing to comply is not generally an overnight process, and taking steps now could be beneficial. The law makes, also, special provisions for small businesses, those with annual gross annual sales for the prior three years of less than $1 million.
CDU: In the next 24 months, how would you define “success” of MoCRA’s implementation?
Kruger: MoCRA is a landmark law. Consumer and product safety are paramount, and the law takes a science-based approach to cosmetic regulation. Successful implementation of the law will require collaboration between the agency and stakeholders.
The law provides tools for the FDA and industry stakeholders to further strengthen consumer trust in cosmetic products. As the agency implements the new law, the industry will likely have numerous opportunities to contribute in the FDA’s contemporary approach to cosmetics oversight.