Last week, the U.S. General Accounting Office (GAO) released the following report: Report to Congressional Requesters on Cosmetic Safety. GAO was asked to review FDA oversight of cosmetic safety. The organization’s report “(1) Research on the safety of selected substances in cosmetics; and (2) FDA actions to implement the new authority and how these actions will lead to selected key practices for agency reform. Find out how well you have handled it.”
To compile the report, GAOWe reviewed scientific literature and FDA documents and interviewed FDA officials.,”,and”We compared FDA’s actions to implement MoCRA with key practices of selected agency reforms.”
GAO’s review of these materials revealed the following:Since MoCRA’s enactment, FDA has taken a number of important steps to implement some of MoCRA’s requirements.”, including appointing a principal investigator to lead MoCRA implementation, the report states:To better ensure the full and successful implementation of MoCRA, FDA should manage and monitor the progress of MoCRA-related efforts against the planned interim steps and interim deadlines included in the implementation plan..” GAO’s report follows the passage of the Cosmetic Regulatory Modernization Act (MoCRA) last December.Expands FDA’s authority to oversee cosmetic safety”
Cosmetic safety testing
In its review and evaluation of research on cosmetic safety, GAO states: DecidedResearch has enough evidence to prove thatthat certain substances contained in cosmetics may be harmful to human health;“Be careful in the meantime”Most of these potentially harmful substances are added by manufacturers to perform a specific function and can take years to develop, so their impact can be difficult to ascertain. .”
For example, parabens are commonly used as preservatives in some cosmetics. ”Some studies have linked it to endocrine problems (i.e., hormonal imbalances).“Further studies reviewed in the report noted that:Other substances may be present unintentionally as impurities, such as asbestos in talc, or as by-products of manufacturing. ” and “Inhalation of asbestos is associated with mesothelioma, a type of cancer that develops in the lining of internal organs.””
Additional substances considered in the report include fragrances, other preservatives, plasticizers, and solvents.
Reporting decision
Considering that.”A 2023 study found that the average American uses 11 to 13 cosmetic products a day, exposing them to approximately 110 unique chemicals.“Implementation of the MoCRA is essential to protect consumer health, and timely enforcement is critical. However, the report finds that at this time:FDA is not sufficiently addressing key practices to ensure the success of agency reform (in this case, the organizational changes necessary to implement the law)“Development, etc.”MoCRA implementation plan…[or] Strategic workforce planning, as required by leading practices, to ensure that agencies have a workforce with the skills and competencies needed to exercise new authority.”
According to the FDA’s lead investigator, the report continues:FDA had not developed such a plan because it was focused on meeting short-term MoCRA deadlines.Therefore, GAO advised that: ”By more fully addressing key practices, including planning, FDA can ensure more successful implementation of MoCRA and promote cosmetic safety.”
The report concluded by identifying several areas where FDA leadership could better track and monitor MoCRA-related progress.Strengthen employee engagement and strategic workforce planning effortsestablish “”A data and evidence collection process to facilitate ongoing evaluation of the effectiveness of these efforts.”
The report continued:If FDA evaluates the law’s impact on FDA’s current and future employees in response to FDA’s expanded authority, leaders will be able to plan more strategically for FDA’s staffing needs.“as”Such an assessment can help develop a strategic workforce plan that identifies the human resources and capabilities, including skills and competencies, needed to implement all MoCRA requirements.”
”By addressing our problems more thoroughly, [GAO] Key practices in government agency reform” concludes the report.FDA will better ensure promotion of public health through efforts to oversee cosmetic safety”
Consideration of GAO recommendations
In conclusion, the GAO report provided seven recommendations to FDA:Strengthen FDA’s efforts to implement new cosmetic safety oversight responsibilities, including development of implementation and strategic workforce plans;”
Here are some recommendations:
The FDA Commissioner should ensure that the Office of the Chief Investigator develops a MoCRA implementation plan that includes interim steps and a timeline that includes interim deadlines to complete all MoCRA requirements within legally mandated deadlines. be. (Proposal 1)
The FDA Commissioner must ensure that the Office of the Chief Investigator reports on key milestones of all MoCRA requirements. Such a reporting process can be incorporated into MoCRA’s implementation plan. (Proposal 2)
The FDA Commissioner should ensure that the Office of the Chief Investigator develops a process to collect the data and evidence necessary to evaluate FDA’s MoCRA implementation efforts against the requirements identified in the new law. Processing and administrative action recommendations for such data can be incorporated into FDA’s MoCRA implementation plan. (Proposal 3)
The FDA Commissioner should ensure that the Office of the Chief Investigator evaluates the current and future workforce impact of implementing all provisions of MoCRA. (Proposal 4)
The FDA Commissioner should ensure that the Office of the Chief Scientist develops a multi-year strategic workforce plan that identifies the personnel and capabilities (including skills and competencies) needed to implement all MoCRA requirements. be. (Proposal 5)
The FDA Commissioner should ensure that the Office of the Chief Investigator develops a plan to strengthen DEIA as it recruits and hires additional staff to implement MoCRA. Such a plan can be incorporated into a multi-year strategic workforce plan for MoCRA implementation. (Proposal 6)
The FDA Commissioner should ensure that the Office of the Chief Investigator employs effective recruiting and employment practices to implement MoCRA, including customized strategies for hiring highly specialized and hard-to-fill positions. There is. Such an approach can be incorporated into a multi-year strategic workforce plan for MoCRA implementation. (Proposal 7)
To date, draft GAO reports have been provided to the FDA and the U.S. Department of Health and Human Services (DHHS) for review. ”The FDA said it generally agreed with our comments. [GAO] Agree with the findings and our recommendations”
”In some cases, the Department has identified actions that FDA plans to take in response.” Compliant with GAO recommendations. Additionally, DHHS “We described future progress in implementing MoCRA and addressing our challenges. [GAO] Recommendation is subject to funding. ”
