Cosmetic Safety: Better Planning Would Enhance FDA Efforts to Implement New Law
Fast Facts
Cosmetics include makeup, shampoo, toothpaste, and more—and many people use multiple cosmetics in their daily or weekly routines. Research has shown that cosmetics may contain harmful substances that can be present intentionally, e.g., as preservatives, or unintentionally, e.g., as natural impurities in ingredients.
In late 2022, a law expanded the Food and Drug Administration's authority to oversee cosmetic safety. While FDA has taken steps to implement the law, we recommended ways to strengthen its approach.
We also included research on the safety of selected substances found in cosmetics and information on related state laws.
Highlights
What GAO Found
Research has established that certain substances found in cosmetics are potentially harmful to human health. However, 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 are chemicals added as preservatives to prevent the growth of microorganisms such as bacteria, but parabens have been linked in some studies to endocrine problems (i.e., hormone imbalances). Other substances may be present unintentionally as impurities, such as asbestos in talc, or as byproducts of manufacturing. Inhalation of asbestos is associated with mesothelioma, a type of cancer that develops on the lining of internal organs.
Examples of Potentially Harmful Substances in Cosmetics
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly expands the regulatory authority of the Food and Drug Administration (FDA). MoCRA requires FDA to take several actions (e.g., issue standards for detecting asbestos in talc) by specific dates through December 2025. FDA has taken important steps to implement MoCRA, such as designating its Chief Scientist to lead FDA's implementation efforts. However, 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. For example:
- FDA has not developed an implementation plan for MoCRA. According to FDA's Chief Scientist, the agency is using MoCRA itself as its roadmap for implementation efforts. However, MoCRA generally does not detail interim steps or deadlines, as called for by project management guidance.
- 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 new authorities.
According to FDA's Chief Scientist, the agency had not developed such plans because FDA had been focused on meeting near-term MoCRA deadlines. By more fully addressing the leading practices, including planning, FDA can better ensure successful implementation of MoCRA and promote cosmetic safety.
Why GAO Did This Study
Cosmetics accounted for approximately $43 billion in revenue in the United States in 2021, according to U.S. Census data, with tens of thousands of cosmetic products and formulations on the market. Consumer groups and some scientists have raised concerns that cosmetics may contain substances that harm human health. In December 2022, a new law—MoCRA—took effect, expanding FDA's authorities to oversee cosmetic safety.
GAO was asked to review FDA oversight of cosmetic safety. This 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. This report also includes information on state laws and regulations that prohibit or restrict substances in cosmetics.
GAO reviewed scientific literature and FDA documents and interviewed FDA officials. GAO compared FDA actions to implement MoCRA with selected leading practices for agency reforms. GAO uses the term “reforms” to include organizational changes, such as those needed to implement new statutory authorities.
Recommendations
GAO is making seven recommendations to strengthen FDA's efforts to implement its new cosmetic safety oversight responsibilities, including developing implementation and strategic workforce plans. FDA concurred with the recommendations.
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Food and Drug Administration | 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) |
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.
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| Food and Drug Administration | 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) |
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.
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| Food and Drug Administration | 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 evidence collection could be incorporated into FDA's implementation plan for MoCRA. (Recommendation 3) |
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.
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| Food and Drug Administration | 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) |
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.
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| Food and Drug Administration | 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) |
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.
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| Food and Drug Administration | 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) |
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.
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| Food and Drug Administration | 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 practices could be incorporated into a multiyear strategic workforce plan for MoCRA implementation. (Recommendation 7) |
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.
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