FDA Unveils Its “First Look” Into How It Will Enforce MoCRA

A warning letter posted by the Food and Drug Administration (FDA) on June 18, 2024 offers a first glimpse into how FDA may enforce its new regulatory scheme for products that fall within the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)’s purview. While MoCRA was enacted in December 2022 and many of its provisions became enforceable on December 29, 2023, until now, many have wondered how FDA will exercise its new enforcement powers.

Following an inspection of a drug manufacturing company in China from December 11 to 14, 2023, FDA issued its June 18th warning letter concluding that the company was in violation of several current good manufacturing practices (CGMPs) for finished pharmaceuticals. The letter went on to explain that the facility may also be subject to the requirements of MoCRA, and provided the facility with MoCRA resources published by FDA. Notably, since some of its provisions became enforceable at the end of 2023, this is the first time of which we are aware that FDA has mentioned MoCRA requirements in any warning letter.    

FDA did not cite the facility with any MoCRA violations, likely because the inspection of the facility in early December 2023 occurred before many MoCRA requirements became enforceable on December 29, 2023. But FDA specifically noted that the violations listed in its warning letter were not exhaustive and instructed the company to investigate and correct any and all violations—strongly suggesting that violation of MoCRA’s enforceable requirements will not be tolerated going forward. FDA’s warning letter also made clear that the agency will withhold approval of new applications from the company and can re-inspect the facility to ensure all existing violations, presumably including those under MoCRA, have been addressed.

FDA’s warning letter was posted a mere 13 days before FDA will begin enforcing MoCRA’s facility registration and product listing requirement on July 1, 2024. In advance of this enforcement date, FDA once again published guidance and other resources, including a facility registration and product listing tutorial, to remind and educate the industry of these upcoming requirements.

As this enforcement date approaches, companies who manufacture and distribute FDA-regulated products should be mindful that, as signaled by its recent warning letter, FDA is already evaluating whether MoCRA applies and is being complied with, even for facilities that primarily manufacture drugs. Indeed, as FDA decides how to allocate its already scarce resources, it is possible that FDA’s preliminary attempts to enforce MoCRA will focus on companies who FDA is already inspecting as part of its authority over drugs, medical devices, and food.