Vireo Advisors, LLC

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US Cosmetic Law reform provides more oversight powers for FDA and removes requirements for animal testing

The US Congress has passed the first update since 1938 to the federal law regulating personal care products. The new law, signed by President Biden on December 29, 2022, requires manufacturers to provide information on all the ingredients in their personal care products, including fragrances and colors, and to keep records supporting each product's safety. They must also register their manufacturing facilities within one year and renew this registration biannually.

The US FDA will now have some of the same oversight powers for cosmetics that it has for other product categories. For example, the agency can require manufacturers to remove a product from the market if there is a "reasonable probability" that it is adulterated and its use may result in significant negative health impacts or mortality. FDA is tasked with identifying, and then mandating, techniques for testing asbestos contamination in talc-containing cosmetics; and with evaluating the safety of per- and polyfluoroalkyl substances (PFASs) – two issues that have generated significant public concern. But, although new personal care product provisions will allow the FDA to review the safety records for other chemicals of concern, it is not required to do so.

Vireo Associates is pleased to note that the act also removes the requirements for animal testing on cosmetic products. These are replaced with "nonclinical tests" which can include cell-based assays, computer modeling approaches, organ chips and microphysiological systems as alternatives to animal testing. We support these modern, mechanistic and more humane approaches for the safety evaluation of new materials.