GAO releases report reviewing 'FDA oversight of cosmetic safety'

14-Dec-2023 - Last updated on 14-Dec-2023 at 16:22 GMT

"To better ensure full and successful implementation of MoCRA, FDA will need to manage and monitor the progress of its MoCRA-related efforts against planned interim steps and interim deadlines contained in an implementation plan," the GAO report said. © RobertDodge Getty Images

Related tags MoCRA Cosmetics safety assessment

In the report, GAO examined research on cosmetic ingredient safety and FDA implementation efforts of MoCRA thus far, which concluded with seven recommendations to 'strengthen FDA's efforts to implement its new cosmetic safety oversight responsibilities, including developing implementation and strategic workforce plans.'

Last week, the US Government Accountability Office (GAO) released its report on cosmetic safety to congressional requesters. The GAO was asked to review FDA oversight of cosmetics safety. The organization's report "examines (1) research on the safety of selected substances in cosmetics and (2) FDA actions to implement its new authorities and the extent to which these actions addressed selected leading practices for agency reforms."

To compile the report, the GAO "reviewed scientific literature and FDA documents and interviewed FDA officials," and "compared FDA actions to implement MoCRA with selected leading practices for agency reforms."

The GAO's examination of these materials determined that while "FDA has taken a number of important steps to implement some of MoCRA's requirements since its enactment," including designating its Chief Scientist as its leader for MoCRA implementation, the report noted that "to better ensure full and successful implementation of MoCRA, FDA will need to manage and monitor the progress of its MoCRA-related efforts against planned interim steps and interim deadlines contained in an implementation plan." The GAO's report follows the Modernization of Cosmetic Regulation Act (MoCRA) passage into law in December of last year, which "expands FDA's authorities to oversee cosmetic safety."

Cosmetic safety examination

In its review and assessment of studies about cosmetic safety, the GAO determined that there is sufficient evidence in the research to establish "that certain substances found in cosmetics are potentially harmful to human health," noting that while "the effects can be difficult to confirm, in part because they may take years to develop, most of these potentially harmful substances are added by manufacturers to serve a specific function."

For example, parabens, typically used as a preservative in some cosmetic products, "have been linked in some studies to endocrine problems (i.e., hormone imbalances)." Further studies examined in the report noted that "other substances may be present unintentionally as impurities, such as asbestos in talc, or as byproducts of manufacturing," and "inhalation of asbestos is associated with mesothelioma, a type of cancer that develops on the lining of internal organs."

Additional substances reviewed in the report include fragrances, other preservatives, plasticizers, and solvents.

Report determinations

Considering that "a 2023 survey found that the average American uses 11 to 13 cosmetics per day, resulting in exposure to as many as approximately 110 unique chemicals," MoCRA's implementation is essential to protecting consumer health, and its timely enforcement is crucial. However, the report determined that at this time, "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," such as developing "an implementation plan for MoCRA…[or] 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 new authorities."

According to FDA's Chief Scientist, the report continued, "the agency had not developed such plans because FDA had been focused on meeting near-term MoCRA deadlines." Therefore, the GAO advised that "by more fully addressing the leading practices, including planning, FDA can better ensure successful implementation of MoCRA and promote cosmetic safety."

In its conclusion, the report identified several areas in which FDA leadership could better track and monitor MoCRA-related progress, including "strengthening employee engagement and strategic workforce planning efforts," and establishing "data and evidence collection processes to facilitate ongoing assessment of the effectiveness of these efforts."

Additionally, the report continued, "Leadership could more strategically plan for FDA's workforce needs if the agency assessed the law's effects on the agency's current and future workforce against the agency's expanded authorities," as "such an assessment could help inform development of a strategic workforce plan that identifies the needed personnel and capacity, including skills and competencies, to implement all of MoCRA's requirements."

"By more fully addressing our [GAO] leading practices for agency reforms," the report concluded, "FDA would better ensure its promotion of public health through its efforts to oversee cosmetic safety."

Examination of GAO recommendations

In its conclusion, the GAO report provided FDA with seven recommendations to "strengthen FDA's efforts to implement its new cosmetic safety oversight responsibilities, including developing implementation and strategic workforce plans."

The recommendations are as follows:

The FDA Commissioner should 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. (Recommendation 1)

The FDA Commissioner should ensure that the Office of the Chief Scientist reports on key milestones for all MoCRA requirements. Processes for such reporting could be incorporated into an implementation plan for MoCRA. (Recommendation 2)

The FDA Commissioner should ensure that the Office of the Chief Scientist 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 Recommendations for Executive Action Page 34 GAO-24-105542 Cosmetic Safety evidence collection could be incorporated into FDA's implementation plan for MoCRA. (Recommendation 3)

The FDA Commissioner should ensure that the Office of the Chief Scientist assesses the effects of implementing all MoCRA provisions on the current and future workforce. (Recommendation 4)

The FDA Commissioner should ensure that the Office of the Chief Scientist develops a multiyear strategic workforce plan that identifies the needed personnel and capacity, including skills and competencies, to implement all MoCRA requirements. (Recommendation 5)

The FDA Commissioner should ensure that the Office of the Chief Scientist develops a plan to strengthen DEIA when recruiting and hiring additional staff to implement MoCRA. Such a plan could be incorporated into a multiyear strategic workforce plan for MoCRA implementation. (Recommendation 6)

The FDA Commissioner should ensure that the Office of the Chief Scientist adopts effective recruitment and hiring practices for MoCRA implementation, such as customized strategies to recruit highly specialized and hard-to-fill positions. Such techniques could be incorporated into a multiyear strategic workforce plan for MoCRA implementation. (Recommendation 7)

To date, a draft of the GAO report has been provided to the FDA for review, and the US Department of Health and Human Services (DHHS) "stated that FDA generally agreed with our [GAO] findings and concurred with our recommendations."

"In some cases, the department identified steps that FDA is planning to take in response" to the GAO's recommendations. Further, the DHHS "stated that future progress in implementing MoCRA and addressing our [GAO] recommendations is contingent upon funding."