On December 11, 2023, the United States Government Accountability Office (GAO) issued a report calling for FDA to strengthen its efforts to implement the Modernization of Cosmetics Regulation Act (MoCRA), and institute reforms necessary to exercise its new authorities under MoCRA.
The GAO’s report, entitled
“COSMETIC SAFETY: Better
Planning Would
Enhance FDA Efforts to Implement New Law,” issues seven recommendations to the Office of the Chief Scientist to implement FDA’s new cosmetic oversight responsibilities:
- Develop an implementation plan for MoCRA — including a timeline with interim steps and interim deadlines — for completing all MoCRA requirements within the statutorily prescribed deadlines.
- Report on key milestones for all MoCRA requirements.
- Develop processes to collect needed data and evidence to measure FDA’s MoCRA implementation efforts against requirements identified in MoCRA.
- Assess the effects of implementing all MoCRA provisions on the current and future workforce.
- Develop a multiyear strategic workforce plan that identifies the needed personnel and capacity, including skills and competencies, to implement all MoCRA requirements.
- Develop a plan to strengthen diversity, equity, inclusion (DEI) and accessibility when recruiting and hiring additional staff to implement MoCRA.
- Adopt effective recruitment and hiring practices for MoCRA implementation, such as customized strategies to recruit highly specialized and hard-to-fill positions.
As previously reported on this blog and elsewhere, MoCRA represents the most significant statutory change to FDA’s ability to regulate cosmetics since the passage of the Federal Food, Drug, and Cosmetic Act (FDCA) in 1938. MoCRA significantly expands FDA’s rulemaking and enforcement authority over cosmetics and creates substantial new compliance obligations for manufacturers, packers, and distributors of cosmetics intended for sale in the United States.
The GAO’s report acknowledges that although FDA has taken important steps in implementing MoCRA, “FDA has not fully addressed leading practices that help ensure the success of agency reforms–in this case, the organizational changes necessary to implement the law.”
The GAO report acknowledges that FDA has undertaken significant organizational changes. In February 2023, FDA proposed moving the Office of Cosmetics and Colors out of its Center for Food Safety and Applied Nutrition (CFSAN) and into the Office of the Chief Scientist to better align the expertise of the agency’s cosmetics subject matter experts with those of the Chief Scientist, who is focused on research, science, and innovation.
However, the GAO noted that FDA has not developed an implementation plan for MoCRA, including interim steps or deadlines; not implemented processes for measuring the results of its efforts against MoCRA’s requirements; and has not developed a strategic workforce to ensure that FDA has the necessary personnel with the requisite skills and competences to exercise its new authorities,
FDA was provided an opportunity to review and comment on the GAO’s report, and generally agreed with its findings and recommendations.
According to FDA’s Chief Scientist, FDA had not developed an implementation plan because FDA had been focused on meeting near-term MoCRA deadlines, such as additional requirements for adequate safety substantiation and adverse event reporting, which take effect December 29, 2023.
Additionally, FDA acknowledged that timely progress in implementing MoCRA and addressing GAO’s recommendations “hinges upon a significant increase in funding.”
Although MoCRA authorized FDA funding levels to increase sharply between 2023 to 2027, with authorized funding levels growing from $14.2 million in FY 2023 to $41.9 million in FY 2025 through 2027, no funding has been specifically set aside for MoCRA implementation. Accordingly, the FY 2024 President’s Budget request includes $5 million for MoCRA implementation, and in particular, hiring new staff. FDA also anticipates requesting funding for additional staff in subsequent fiscal years in order to fully implement MoCRA.
The GAO’s report comes shortly after FDA announced last month that it intended to delay enforcement of MoCRA’s requirements for cosmetic product facility registration and product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024.
This delay is intended to provide the personal care products industry additional time to comply with these requirements, and comes in response to industry concerns about the need for additional time to gather information required for facility registration and product listing.
FDA has advised that it will be ready to accept registration and listing information by the statutory deadline of December 29, 2023, and encourages companies to meet that deadline if they are able to do so.