US Accountability Office wants FDA to advance MoCRA by “strengthening its efforts” to implement new cosmetic safety oversight responsibilities

11 Dec 2023 --- The US Government Accountability Office (GAO) calls for better planning in the FDA to implement laws against harmful cosmetic ingredients. 

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) expands the regulatory authority of the FDA, requiring the FDA to take several actions — such as issuing standards for detecting asbestos in talc — by specific dates through December 2025. 

The GAO states the FDA has not fully addressed leading practices that help ensure the success of agency reforms and has not developed an implementation plan for MoCRA. A six-month delay has been issued, allowing companies to register their cosmetic facilities and product listings in line with the new obligations.

Research shows certain substances found in cosmetics are potentially harmful to human health. Most of these potentially dangerous substances are added by manufacturers to serve a specific function. 

For example, parabens are added as preservatives to prevent the growth of microorganisms such as bacteria. 

“We found that some eye shadows contain parabens, which are preservatives potentially linked to interference with the function of the endocrine system. We also noted shampoos that contain fragrances associated with allergic reactions on the skin,” a GAO spokesperson tells Personal Care Insights.

“In addition, we reported that some substances may be present unintentionally as impurities, such as asbestos in talc, or as manufacturing byproducts. Inhalation of asbestos is associated with mesothelioma, a type of cancer that develops on the lining of internal organs.”

The GAO gives seven recommendations accepted by the FDA for MoCRA.Issues with organization
According to the FDA’s chief scientist, the agency uses MoCRA as its roadmap for implementation efforts. The GAO critiques how MoCRA generally does not detail interim steps or deadlines, as called for by project management guidance.

The report says the FDA has not developed a strategic workforce plan, as called for by leading practices, to help ensure that the agency has the necessary personnel with the requisite skills and competencies to exercise its authority.

The FDA’s chief scientist further states the agency had not developed such plans because the FDA had been focused on meeting near-term MoCRA deadlines. The GAO recommends that by more fully addressing the leading practices, including planning, the FDA can better ensure the implementation of MoCRA and promote cosmetic safety.

Recommendations for MoCRA
According to US Census data, cosmetics accounted for approximately US$43 billion in revenue in the US in 2021, with tens of thousands of cosmetic products and formulations on the market. 

“Our report offered seven recommendations on how the FDA could strengthen its efforts to implement its new cosmetic safety oversight responsibilities, including developing implementation and strategic workforce plans. FDA agreed with our recommendations,” explains the spokesperson.

The recommendations include the FDA Commissioner ensure that the Office of the chief scientist: 

• Develops an implementation plan for MoCRA — including a timeline with interim steps and interim deadlines — for completing all MoCRA requirements within the statutorily prescribed deadlines.
• Reports on key milestones for all MoCRA requirements.
• Develops processes to collect needed data and evidence to measure the agency’s MoCRA implementation efforts against requirements identified in the new law. Such processes for data and evidence collection could be incorporated into the FDA’s implementation plan for MoCRA.
• Assesses the effects of implementing all MoCRA provisions on the current and future workforce.
• Develops a multiyear strategic workforce plan that identifies the needed personnel and capacity, including skills and competencies, to implement all MoCRA requirements.
• Develops a plan to strengthen diversity, equity, inclusion and accessibility when recruiting and hiring additional staff to implement MoCRA. Such a plan could be incorporated into a multiyear strategic workforce plan for MoCRA implementation.
• Adopts effective recruitment and hiring practices for MoCRA implementation, such as customized strategies to recruit highly specialized and hard-to-fill positions. Such practices could be incorporated into a multiyear strategic workforce plan for MoCRA implementation.

By Sabine Waldeck