Changes Coming to How FDA Regulates Cosmetics

The FDA announced on Feb. 28, 2023, it will move cosmetics regulation out of the CFSAN and into the OCS. The move stems from the FDA's broader initiative to reorganize food safety regulation and oversight, as well as allow the agency to have a separate office address the new regulations enacted late last year as part of a congressional omnibus appropriations bill.

Regulation of Cosmetics

Currently, FDA does not preapprove or authorize cosmetics, with the exception of color additives. FDA also does not require cosmetics be manufactured under good manufacturing practices, does not require manufacturing facilities be registered with the FDA and does not require product listing. FDA does require cosmetic manufacturers to ensure that their products are not adulterated or misbranded. Cosmetic companies are responsible for marketing safe, properly labeled products, using no prohibited ingredients and adhering to limits on restricted ingredients.

The FDA is responding to charges that its regulatory functions need improvement and better focus. FDA hopes to finalize its food and cosmetics reorganization proposals this fall. In addition, FDA is currently looking to hire a new deputy commissioner for human foods. These organizational changes come on the heels of significant changes to the U.S. Federal Food, Drug, and Cosmetic Act that impact the regulation of cosmetics. These changes were enacted in December 2022 as part of a broad omnibus appropriations bill to give FDA more oversight and regulatory authority over cosmetics manufacturers and impose new requirements on manufacturers. For example, the new provisions:

• authorize FDA to recall a product if the agency believes there is a "reasonable probability that a cosmetic is adulterated or misbranded and the use of or exposure to such cosmetic will cause serious adverse health consequences or death"
• authorize FDA to issue good manufacturing regulations for cosmetics manufacturers; a proposed regulatory scheme is required within two years
• require manufacturing facilities – including those operated by contract manufacturers – to register with FDA
• authorize FDA to suspend the registration of a facility if the agency determines that a cosmetic product manufactured or processed by that facility "has a reasonable probability of causing serious adverse health consequences or death to humans and the Secretary has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility"
• require every cosmetic product – those already marketed and those brought to market after the bill's enactment – to be listed by the manufacturer and submitted to the FDA and to be properly labeled
• authorize the FDA to review a manufacturer's records if the agency has a "reasonable belief that a cosmetic product, including an ingredient in such cosmetic product, and any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to humans"

Importantly, the omnibus appropriations bill contains a preemption clause saying that no state can establish or continue to enforce any law or regulation that is "different from or in addition to, or otherwise not identical with" the bill's requirements.

Two other provisions of the bill require FDA to issue regulations to establish and require standardized testing methods for detecting asbestos in cosmetics containing talc and to assess the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products.

The bill represents the first changes in cosmetics regulation since the 1930s.

Next Steps

FDA will begin the regulatory process this year, and greater oversight of cosmetics is expected. Holland & Knight will continue to closely monitor these changes and activities.

For additional information or questions regarding these changes, please contact the authors.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.