New regulatory requirements for cosmetic products in the United States

New regulatory requirements for cosmetic products in the United States: Consolidated Appropriations Act 2023

In the end of 2022, the omnibus spending bill passed the Congress and has been signed into law on December 29. This bill includes more than 4000 pages and also includes an amendment to the US Federal Food, Drug, and Cosmetic Act (FDCA) (sections 3501-3508)[1], often referred to as the “Modernization of Cosmetics Regulation Act 2022” (MOCRA).

This amendment represents the first significant update of the US cosmetics legislation since almost 85 years and will provide a huge impact for manufacturers, distributors and importers of cosmetic products in the US with its final entering force in December 2023.

The new requirements significantly expand the scope of FDA’s competences and add additional compliance requirements for companies producing and selling cosmetic products in the US who should quickly prepare for the changes.

As an important improvement, the amendment provides the FDA with the possibility to authorise recalls of products, which are e.g. proven as unsafe, misbranded, etc., given that the affected facility does not voluntarily recall the product.

In accordance with the amendment, facilities (e.g. manufacturers, importers and distributors of cosmetic products ) will have the (among others) following legal obligations:

• Reporting of serious adverse health events, when caused by cosmetic products.
• Registration of the facility with the FDA
• Listing of cosmetic products (similar to notifications in the EU and UK)
• Duty to keep records of cosmetic products regarding safety
• Indicating of fragrance allergens in addition to the list of ingredients

The new competences of the FDA includes (among others) the following

• Request of records related to product safety and ingredients if there are concerns a product may be not safe, misbranded, etc.
• Possibility to request a mandatory recall of products that are not safe, misbranded, etc.
• Establish Good Manufacturing Practices (GMP) that all facilities will be required to follow in the next years.

In summary, cosmetic facilities and responsible persons must prepare themselves for facility registration and product listing before December 2023. The new requirements concerning product safety, labelling (especially regarding fragrance allergens), GMP compliance, reporting of adverse events, record keeping, should be carefully reviewed and, where required, products brought into compliance accordingly.

[1] https://www.congress.gov/bill/117th-congress/house-bill/2617