Product Regulation: A New Challenge for Cosmetics Makers: Dealing With the FDA

Key developments expected this year, as the FDA ramps up the implementation of major new cosmetics regulations, could shape the class action landscape for the beauty and wellness industry for years to come, says Crowell & Moring partner Robbie Rogart Jost.

When Congress passed the Modernization of Cosmetics Regulation Act in 2022, it was the most significant expansion of the Food and Drug Administration’s authority to regulate cosmetics in more than 80 years. Prior to MoCRA, cosmetics industry reporting on safety information, such as product ingredients and adverse health events, was largely voluntary.

Starting in July 2024, the FDA began enforcing a MoCRA provision requiring major cosmetics manufacturers to register facilities where each product is made and designate a “responsible person,” who is tasked with listing each marketed cosmetics product, along with its ingredients, with the FDA.

That responsible person must also receive adverse health event reports and disclose to the FDA any “serious” reports associated with the product within 15 days.

Because the structure of MoCRA mirrors the way the FDA regulates medical devices in many key respects, including for adverse event reporting, Jost says it would not be surprising to see a MoCRA adverse event reports database similar to the one for medical devices, known as the Manufacturer and User Facility Device Experience database, or MAUDE. MAUDE is easily searchable by a variety of parameters, including keyword, product name, and date of reports.

While MoCRA does not create a private right of action for consumers who allegedly have been harmed by a product, such a database could provide information to those looking to launch class action lawsuits.

As Jost explains, “If someone sees there have been 150 reports in the last two weeks about this hand cream or that mascara, well then that’s just a road map for a plaintiff’s attorney.”

In addition to MoCRA’s disclosure requirements, the legislation directs the FDA to issue a report no later than the end of 2025 on the use and safety in cosmetics of perfluoroalkyl and polyfluoroalkyl—widely used, long-lasting chemicals also known as PFAS. PFAS in cosmetics such as mascara and foundation have been the subject of several recently launched class action lawsuits alleging that cosmetics companies failed to list the chemicals as ingredients in their products.

Jost says it is unlikely the FDA report will offer definitive proof that PFAS are or are not harmful in cosmetics, but there’s no doubt its report will become an important data point in litigation. “MoCRA represents a seismic change for an industry that has not had to meaningfully deal with the FDA, so it’s difficult to predict the implications,” she says. “We should begin to have a clearer picture in the year ahead.”