FDA Sets July 1 Deadline for Cosmetics Importers to Register Facilities and Products

By July 1, 2024, cosmetics importers and manufacturers must register their facilities and list their products with the FDA. This applies to all facilities involved in the production or processing of cosmetics for the U.S. market.

Cosmetics importers and manufacturers are required to register their facilities and list their products with the U.S. Food and Drug Administration (FDA) by July 1, 2024. This requirement is part of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

According to MoCRA, the term “facility” encompasses any establishment, whether located within the U.S. or internationally, that manufactures or processes cosmetic products intended for distribution in the United States. This includes not only manufacturing and processing facilities but also extends to those handling ingredient production and laboratories engaged in batch testing.

Furthermore, cosmetics importers are obligated to appoint a “responsible person” to submit a comprehensive list of all cosmetics products (including ingredients) available in the U.S. market. The "responsible person,” typically the manufacturer, packer, or distributor listed on the product’s label, is the entity mandated to complete this registration and is also responsible for ensuring that the facility and its products meet all the necessary regulatory requirements.

To facilitate submissions, the FDA has developed a dedicated electronic portal, Cosmetics Direct. While this is not the sole method for submitting the necessary documentation, it is designed to simplify the process and enhance user experience, making compliance more straightforward for cosmetics importers and manufacturers.

Exemptions from this mandate

While MoCRA introduces comprehensive requirements, it does provide exemptions for certain small businesses from Good Manufacturing Practices (GMP), registration, and product listing requirements. 

However, these exemptions do not apply to facilities or manufacturers producing cosmetics that:

• Come into regular contact with the eye’s mucus membrane under normal usage conditions.
• Are intended for injection.
• Are meant for internal use.
• Are designed to alter appearance for more than 24 hours where consumer removal is not a typical condition of use.

Exemptions are also granted for specific products and facilities already regulated under drug and device requirements.

How to register your facilities and list your products

If you’re a cosmetics importer or manufacturer, you can use the FDA’s Cosmetics Direct platform to register your facilities and list your products. The FDA has published a comprehensive 'Guidance for Industry,' which provides detailed information to help you.

If you require assistance or have any questions about these new requirements and your compliance, please reach out to one of our trade professionals.