The U.S. Food and Drug Administration (FDA) established registration and listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).  MoCRA introduces significant changes to how cosmetic products and facilities are regulated, providing the FDA with new oversight authorities and establishing new compliance obligations for the cosmetic industry.

Staying compliant with these updated regulations is crucial for manufacturers of cosmetic products.  Cosmetic manufacturer facility registration is one new requirement under MoCRA, and the deadline for this registration is July 1, 2024. 

Facility Registration:

• Who Needs to Register: All manufacturers and processors of cosmetic products.

• Frequency: Initial registration, updates within 60 days of any changes, and biennial renewals.

Product Listing:

• Responsibility: A "responsible person" (manufacturer, packer, or distributor listed on the product label) must list each marketed cosmetic product with the FDA.

• Details Required: Product ingredients and annual updates.

Exemptions to Note

While MoCRA provides some exemptions for small businesses, these do not extend to facilities involved in:

• Products used in the eye's mucus membrane.

• Injected products.

• Products intended for internal use.

• Products designed to alter appearance for over 24 hours without consumer removal.

Additionally, certain products and facilities that fall under drug and device regulations are also exempt.

Resources and Tools for Compliance

To support the industry, the FDA has created a dedicated web page consolidating all relevant resources for registration and listing of cosmetic product facilities and products. Key tools and guidance include:

• Structured Product Labeling (SPL) Implementation Guide with Validation Procedures: This guide helps in developing SPL authoring tools for submissions via the FDA’s Electronic Submissions Gateway (ESG).

• Cosmetics Direct Electronic Submission Portal: Launched in December 2023, this portal facilitates electronic submissions for registration and listing. Comprehensive tutorials and a user guide are available to assist users.

• Xforms: An SPL authoring tool introduced in January 2024 to simplify the submission process.

• Paper Forms (FDA 5066 and FDA 5067): Available for those who prefer or need to submit information in paper format.

How to Proceed

To comply with MoCRA by the July 1, 2024 deadline, companies should:

1. Register Facilities: Ensure all manufacturing and processing facilities are registered with the FDA.

2. Complete Product Listings: List all marketed cosmetic products, including detailed ingredient information, and update these listings annually.

3. Utilize Available Resources: Leverage the FDA’s online tools, guides, and tutorials to streamline the registration and listing process.

By adhering to these new regulations and utilizing the resources provided, manufacturers can ensure they remain compliant and continue to bring safe and effective cosmetic products to market. Contact Thompson PLLC for more information to help you remain compliant with these updated regulations.