In a somewhat unexpected move, Congress enacted the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on December 29, 2022, as part of the Omnibus Appropriations Act. MoCRA significantly strengthens the U.S. Food and Drug Administration’s (FDA) authority over cosmetic products. Key provisions are summarized below.
Background
To some, FDA’s regulation of cosmetics is not as robust as it should be. Detractors have claimed for years that FDA should regulate cosmetics more systematically and thoroughly. MoCRA is Congress’s response, and its enactment ushers into place significant cosmetic regulatory oversight.
Facility Registration. A key change is requiring registering the facility at which cosmetics are manufactured and providing product details. This requirement enters into force in December 2023 for existing facilities. “Facility” is defined as “… any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.” Entities not included in this definition include beauty shops, salons, retailers, hospitals, hotels, airlines, trade shows, research facilities, and establishments that only label, relabel, package, repackage, hold or distribute.
Much work remains to be done to implement MoCRA.
Good Manufacturing Practice (GMP). The FDA must propose a rule no later than two years from enactment intended to establish regulations for GMPs for facilities, with a final rule issued within three years. The proposed GMP requirements should align with national and international standards and are meant to ensure that cosmetic products are not adulterated.
Adverse Event Reporting. MoCRA requires adverse event submissions within specific timeframes. Serious adverse events must be reported no later than 15 business days after the person responsible receives the report. Records related to adverse events must be kept for six years.
Cosmetic Safety Substantiation. MoCRA requires safety substantiation for cosmetic products. The details requested are that “A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of the safety of such cosmetic product.” “Safe” means “… that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual.” The requirement is assumed to be enacted within one year, as it is not stipulated otherwise.
Voluntary Cease Distribution/Recall of Adulterated Cosmetics. MoCRA provides that if there is a reasonable probability a cosmetic is adulterated, and the use will result in a severe health issue, FDA is authorized to offer the responsible party the option of voluntarily recalling the product, including no longer selling or distributing the product. If the responsible party refuses or fails to act within the prescribed time and manner, the FDA will require immediate recall of the product. Public notification is included in these requirements.
Labeling. This includes provisions related to the addition of contact details for adverse event reporting, additional consideration for fragrance allergens, and further clarification of cosmetic products for professional use. Labeling requirements must take effect two years after the date of enactment.
PFAS. MoCRA mandates the FDA to assess the use, safety, and risks associated with per- and polyfluoroalkyl substances (PFAS) in cosmetics no later than three years from enactment. FDA is also required to publish a report on its website with the results of the assessment.
Discussion
MoCRA is consequential. Cosmetic product stakeholders will need to monitor and engage in the many initiatives the new law requires. Facility registration is a big deal, as is the addition of GMPs, which will require rulemaking to implement. FDA’s definition of “adulterated” is basic and has served as a mechanism for FDA to address issues that result from deficient manufacturing quality. It is unclear how cosmetic products can comply with whatever GMPs the FDA ultimately develops. GMPs exist within the FDA framework, but it is defined differently depending on the use (i.e., for drugs, devices, foods, or food contact substances).
It is not surprising to see the inclusion of serious adverse event reporting and mandatory recalls among MoCRA’s provisions. These concepts are core to FDA regulations, and the agency’s extension of authority in these areas to include cosmetics is, according to some, long overdue. That said, how FDA will implement these new authorities is unclear. The FDA may utilize existing tools developed for food to address this space as well.
Much work remains to be done to implement MoCRA. FDA engagement with the regulated community will enable stakeholders to assist FDA better in undertaking the challenges that implementation of the law invites.
