New FDA draft guidance on cosmetic facility registration and product listing

On August 7, 2023, FDA issued a draft guidance on cosmetic facility registrations and product listings, pursuant to its new authorities under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).[1]

MoCRA, signed into law on December 29, 2022, is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act (FDCA) was initially enacted in 1938.  MoCRA gave FDA mandatory recall authority for adulterated or misbranded cosmetic products and established several new requirements for the industry, including adverse event reporting, facility registration, product listing, and safety substantiation, among others.

The draft guidance, once finalized, will provide specific procedures and the timeline for facility registration and product listing requirements.

New Requirements: facility registration and product listing

MoCRA added section 607 to the FDCA, which requires all covered facilities to register the facility and submit product listing information.

Under section 607(a), cosmetic product manufacturers and processors must register their facilities with FDA, update content within 60 days of any changes, and renew their registration every 2 years. 

Under section 607(c), a responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.  The responsible person is defined as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act).

Failure to register or submit listing information in accordance with section 607 is a prohibited act.

Covered facility and exemptions

Any facility that manufactures or processes a cosmetic product for distribution in the United States is required to register and submit a product listing unless excluded or exempt.  A facility that only labels, relabels, packages, repackages, holds, or distributes cosmetic products does not have to register or list.

MoCRA exempts from section 607’s registration and product listing requirements small businesses whose average gross annual sales of cosmetic products in the US for the previous 3-year period is less than $1,000,000, adjusted for inflation, unless the facility manufactures or process the following products:

• Cosmetic products that regularly come into contact with mucus membranes of the eye under conditions of use that are customary or usual
• Cosmetic products that are injected
• Cosmetic products that are intended for internal use, or
• Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.

Only facilities that manufacture cosmetics that are not also regulated as drugs or devices are covered.  Similarly, products that are both cosmetics and drugs or devices are not subject to the product listing requirement. In addition, the draft guidance clarified the types of facilities that are not included under MoCRA, such as beauty shops and salons, cosmetic product retailers, trade shows where free cosmetic samples are provided, among others.

What to do if you are covered

All covered facilities and products are expected to submit the required information on or before December 29, 2023.  A new electronic submission portal will be available for submitting registration and product listing information in October 2023, and FDA will also provide a paper form as an alternative submission tool, although electronic submission is strongly preferred.

Facilities that previously submitted information under the “voluntary cosmetic registration program” also must complete the section 607(a) submission because FDA clarified that information in the voluntary program will not be transferred to this new system.

The draft further clarified that, before starting the registration submission, the responsible person must first obtain an FDA Establishment Identifier (FEI) number.  Contract manufacturers only need to register once, but the brand names of all products manufactured at the time of registration must be identified.  In addition to the mandatory reporting information, FDA requests the following “optional” information: parent company name, facility DUNS number, and additional contact information for individuals associated with the registration.

For product listings, which must list the “category” of cosmetic, FDA has provided a list of product categories and codes.  FDA also requested more “optional” information, such as parent company name, type of business, image of the label, and product webpage link. If the product’s manufacturing facility is a small business that is exempt from registration, and therefore has no facility registration number, then the facility name and address can be provided instead.

Public disclosure

FDA will not disclose (1) product listing number information or (2) the brand names under which cosmetic products manufactured or processed in the facility are sold, in response to a Freedom of Information Act (FOIA) request.  However, all other information from the facility registration and product listing would be subject to public disclosure under FOIA requests.  FDA intends to make relevant information available to the public to the extent permitted by law.

Interested parties should submit the comments on or before September 7, 2023. To find out more about new requirements under MoCRA for your company please contact any of the authors.