On August 7, 2023, the U.S. Food and Drug Administration (FDA) released draft Guidelines for Cosmetic Facility Registration and Product Listing, which address the requirements for facility registration and product listing in the Cosmetic Regulation Modernization Act of 2022 (MoCRA). The draft guidelines are open for comment until September 7, 2023.

  Draft Guidelines

The draft guidance provides detailed answers on who is responsible for submitting registration and listing requests, what information needs to be included, how and when to submit it, and certain exemptions from registration and listing requirements.

In addition, the draft contains information on the new electronic registration and list submission platform.

New Electronic Submission platform

The FDA plans to launch the new electronic submission platform in October 2023. The FDA strongly recommends that companies use electronic submissions to promote efficiency and timeliness in data submission and management. The FDA is also developing paper forms as an alternative submission tool to the electronic submission portal.

Facility Identifier (FEI)

As described in the draft guidance, FDA will use the FDA Facility Identifier (FEI) as the required facility registration number.

To simplify the registration process, the owner or operator of a facility is required to obtain an FEI number before submitting a facility registration.

The Responsible Person is required to obtain the relevant FEI number for each manufacturing or processing facility of its cosmetic products and is required to provide the facility registration number at the time of product listing submission. If the facility is a small business that is exempt from registration and does not have a facility registration number, the facility name/address can be provided as an alternative to the product listing.

As required by the Cosmetic Regulatory Modernization Act (MoCRA), companies are required to register their facilities and list their products by the statutory deadline of December 29, 2023.

Voluntary Pilot Scheme

In addition, FDA is soliciting applications from members of the cosmetics industry who wish to participate in a voluntary pilot program to conduct User acceptance testing (UAT) to help evaluate potential electronic submission platforms for facility registration and listing of new cosmetic products.

FDA plans to accept up to nine participants for the pilot program. The pilot program aims to provide input from participants to improve the e-submission platform.

< Background of the draft guidelines

Implementation of MoCRA regulations

On December 29, 2022, President Joe Biden signed into law the Omnibus Appropriations Act of 2023 (H.R.2617), which contains the Cosmetic Regulation Modernization Act of 2022 (MoCRA). This marks the first major revision of the Federal Food, Drug, and Cosmetic Act (FDCA) of 1938 and the first statutory change to FDA's cosmetic regulations in 85 years.

Facility registration and product listing are the two new requirements of MoCRA. Under the MoCRA Act, both Facility registration and product registration are mandatory requirements.

Facility registration

“ Facilities ” Manufacturers and processors involved in the sale of cosmetics in the United States, whether located in the United States or not, must register with the FDA and renew their registration every two years.

Existing enterprises must complete registration before December 29, 2023; New businesses must register within 60 days of starting production of cosmetics, or 60 days after the deadline for existing businesses, whichever is later.

Product list

The Responsible Person is required to provide FDA with information about each cosmetic product on the market, including the ingredients of the product, where it was manufactured, the cosmetic label, and contact information.

For products sold before the enactment of MoCRA, the responsible person must submit the product registration information by December 29, 2023;

For products that are first marketed after promulgation, the responsible person must submit product registration information within 120 days of listing. Cosmetic product registration must be renewed annually.