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According to National Public Radio (NPR), 3.500 jobs are being eliminated at the US FDA.These layoffs are expected to have ripple effects in the beauty industry, as it impacts functions that support the Office of Cosmetics and Colors. Layoffs within the Office of Inspections and Investigations (OII) could lead to fewer routine inspections, potentially shifting focus to higher-priority inspections related to safety issues or troubled facilities. While the FDA doesn't pre-approve cosmetic products (with some exceptions for color additives), it is responsible for ensuring products are safe and properly labeled. The reduced workforce could mean the FDA takes longer to implement and enforce new regulations and guidance documents, impacting compliance for cosmetic companies. With fewer resources, the FDA may need to prioritize its efforts on specific areas of concern within cosmetic regulation. These large-scale reductions in staff will likely postpone the implementation of the anticipated regulation under the Modernization of Cosmetics Regulation Act (MoCRA). For instance, the FDA is poised to issue a ruling with regards to allergens and their disclosure on product labels which is likely to be delayed. Furthermore, the much-anticipated Good Manufacturing Practices (GMP) proposed ruling taking place in 2025 is also likely to be delayed. The Draft Guidance was published over 10 years ago, in June 2013, and MoCRA tasks the FDA to provide a rulemaking regarding GMP sometime this year.
Overall, while the FDA's role in ensuring the safety and regulation of cosmetics remains, the layoffs may slow down the process of implementing and enforcing new regulations and may lead to a shift in focus within the agency's cosmetics oversight.
On January 15, 2025, the FDA revoked the authorization for the use of FD&C Red No. 3 for food use, because two studies showed an increase incidence of thyroid cancer in laboratory male rats exposed to high levels of FD&C Red No. 3 (C.I. 45430 AKA erythrosine). However, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans. Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats. Studies in other animals and in humans did not show these effects; claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information. Manufacturers who use FD&C Red No. 3 in food and ingested drugs will have until January 15, 2027 or January 18, 2028, respectively, to reformulate their products. In 1990, the FDA banned the dye’s use in cosmetics and topical application after research found increased cancer rates among rodents following oral exposure. Color additives permitted for use in cosmetics are listed in 21 CFR 73 Subpart C and are required to be approved by the FDA prior to use.
On March 13, 2025, the European Union announced a proposal to update the glossary of common ingredient names in cosmetics in the EU Regulation (EC) No 1223/2009, while abolishing the current Commission Implementing Decision (EU) 2022/677 to standardize ingredient labeling and improve ingredient identification. The draft is expected to be approved in the second quarter of 2025, and will officially come into effect 20 days after its publication in the Official Journal of the EU. However, the application of the Decision should be deferred for a period of 12 months with a possibility for the economic operators to immediately start applying the new glossary.
What is being revised:
Launched in November 2023, the COSMILE Europe app provides consumers with information on 30.000 cosmetic ingredients, some of which can cause allergic reactions in sensitive individuals. Now available in 13 languages, the user can download the app on their phone and search for ingredient information by scanning the ingredients list on the product label, search for information on an individual ingredient manually, or scan a product barcode to retrieve information about the product and its ingredients list. The app can be personalized and the users can create a list of favorite products from the cosmetics they have scanned to consult the products' ingredients at any time.
💡 Christine's Takeaways: MoCRA anticipated ruling on allergens and GMP are likely to be delayed due to the massive FDA layoffs creating uncertainty and compliance gaps in the industry. If you are using a color in your cosmetic product, you need to ensure that it is listed in the 21 CFR. If it is not listed, you are required to submit to the FDA a Color Additive Petition in order to be able to use the new color in a cosmetic product. The European Union is proposing to make changes to the glossary of common ingredient names used in cosmetics. Always ensure that you are up to date with the appropriate INCI name nomenclature for ingredients listed on your label. Ensure that the CI number for each color is included on the product label.
👉 If you want to know more about how to comply with the cosmetic regulation in the USA, Canada and Europe and your regulatory and safety obligations as a manufacturer ,don’t hesitate to reach out to Christine Thiffault, PhD DABT ERT at cthiffault@toxessential.com, Toxicology Expert at ToxEssential, or visit the website: toxessential.com