FDA to Enforce Cosmetics Facility Registration July 1, 2024

As the landscape of cosmetics regulation continues to evolve, it’s essential for importers and distributors to stay abreast of the latest requirements set forth by regulatory bodies. One such significant development is the enforcement of the Modernization of Cosmetics Regulation Act (MoCRA) by the Food and Drug Administration (FDA). Effective July 1, the FDA will begin enforcing this act, mandating that clients importing cosmetics products have their facilities registered with the FDA.

 

The cornerstone of compliance with MoCRA lies in facility registration. By July 1, all facilities involved in importing cosmetics products must ensure their registration with the FDA. This registration process is crucial as it facilitates the FDA’s oversight of cosmetic products entering the U.S. market, ensuring they meet safety and labeling requirements.

 

Additionally, by the same deadline, a designated “responsible person” must furnish the FDA with a comprehensive list of all cosmetics products marketed in the United States. This list should include detailed information on the ingredients of each product. The responsible person, as defined by the FDA, encompasses the manufacturer, packer, or distributor whose name appears on the label of the cosmetic product.

 

To aid in compliance, the FDA has provided a detailed list of cosmetic product categories, streamlining the identification and classification process for importers and distributors. This resource serves as a valuable tool for ensuring accurate categorization and reporting of cosmetics products.

 

While the FDA has not introduced new requirements at the point of entry for now, importers and customs brokers should anticipate future changes. While registration numbers and other cosmetics-related data are not currently required during the entry process, it’s prudent to stay vigilant for updates from the FDA. The agency has assured stakeholders that any forthcoming changes will be communicated well in advance, allowing ample time for necessary adjustments to software and systems.

 

It’s imperative for manufacturers and processors to understand their obligations regarding facility registration. Registration must be completed with the FDA, with renewal required every two years. The FDA holds the authority to suspend a facility’s registration under specific circumstances, particularly if there is a reasonable probability of serious adverse health consequences associated with a cosmetic product distributed by the facility.

 

In the event of a registration suspension, the distribution or sale of cosmetic products from the affected facility becomes a prohibited act. This underscores the importance of stringent adherence to regulatory requirements and proactive measures to ensure product safety and compliance.

 

The enforcement of MoCRA by the FDA signifies a pivotal moment in cosmetics regulation. Importers, distributors, manufacturers, and processors must prioritize compliance with registration and reporting obligations to uphold product safety standards and maintain consumer trust. By staying informed, proactive, and engaged with regulatory developments, stakeholders can navigate these changes effectively while contributing to the overall safety and integrity of the cosmetics industry.

 

Want to know more about how this may affect you? Reach out to Future Forwarding today. 

 

Helpful Links:

Cosmetic Product Categories and Codes

Form FDA 5066 – Registration of Cosmetic Product Facility

Form FDA 5067 – Cosmetic Product Listing