The U.S. Food and Drug Administration (FDA) issued comprehensive guidance under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This update marks a much-needed advancement in the cosmetics regulatory framework, addressing facility registration, product listing, and compliance deadlines.
Key Highlights of the New Guidance:
- Facility Registration and Product Listing: All facilities that manufacture or process cosmetics for distribution in the U.S. must register with the FDA. Additionally, each cosmetic product must be listed with the FDA. This listing includes providing detailed information about the product’s ingredients and the facilities where they are manufactured or processed.
- Electronic Submission Portal: The FDA has launched a new electronic portal, Cosmetics Direct, for the submission of facility registrations and product listings. This system will streamline the process and make it easier for businesses to comply with the new regulations.
- Compliance Deadlines: There are specific deadlines for initial registrations and listings. For instance, facilities engaged in manufacturing or processing cosmetics as of December 29, 2022, must register by July 1, 2024. The listing must also be submitted by July 1, 2024, for cosmetic products marketed by that date.
- Exemptions: Small businesses with less than $1 million in average annual gross sales of cosmetic products in the U.S. over the last three years are exempt from some of these new requirements unless they produce products with higher risk profiles, such as those intended for injection or internal use.
- Adverse Event Reporting: MoCRA requires responsible persons to report serious adverse events associated with their cosmetic products to the FDA within 15 business days. This requirement is a critical change aimed at enhancing consumer safety.
- Labeling Changes: There may be new labeling requirements, including declaring allergens. Businesses should stay informed about these potential changes to ensure compliance.
- Documentation and Record Keeping: Enhanced record-keeping will be essential. Businesses must maintain detailed records of product formulations, manufacturing processes, and adverse event data to ensure compliance and facilitate any necessary inspections or audits.
What Does This Mean for the Industry?
Businesses in the cosmetic industry must now ensure their facilities are registered and their products listed per the new guidelines. This includes updating any facility changes within 60 days and renewing registrations biennially. Product listings must also be updated annually and upon marketing new products.
Moving Forward:
These modern regulations aim to improve the safety and transparency of all cosmetic products sold in the U.S. by ensuring they meet consistent regulatory standards. Stakeholders should review the complete FDA guidance, take note of the compliance deadlines, and consider any necessary adjustments to their operational strategies.
The complete guidance is available on the FDA’s website for more detailed information on how these changes could impact your business and for further assistance on these new regulations. If you have questions or concerns about your cosmetic shipments or need guidance on another FDA situation, Argents is ready to assist you.
