FDA Issues Draft Guidance on Registration and Listing for Cosmetics Required under MOCRA

On August 7, 2023, a little less than five months before the registration and listing of cosmetic product facilities and products becomes mandatory, FDA announced the availability of a draft guidance regarding the new facility registration and product listing requirements under the Modernization of Cosmetic Regulations Act of 2022 (MOCRA).  The information is presented in a Q&A format.

As reported previously, MOCRA includes a requirement for facility registration and listing of cosmetic products.  Specifically, with some exceptions, parties that own or operate a facility engaged in the manufacturing or processing of a cosmetic product for distribution in the United States must list their facilities.  In the case of contract manufacturers, either the contract manufacturer or the person whose name appears on the label (i.e., the “responsible person”) must register (only one single registration per facility is required, even if the same facility contract manufactures products for more than one responsible person).   As discussed in the draft guidance, before registration, a facility must have a facility registration number which will be the facility establishment identifier (FEI).  Companies that do not have a FEI can request one.

MOCRA also requires that the responsible person for each cosmetic product submit a product listing. A single listing submission may include multiple cosmetics with identical formulations or formulations that differ only in respect to colors, fragrances or flavors, or quantity of contents.   The cosmetic product listing information must include the facility registration number of each facility where the cosmetic product is manufactured or processed.  For facilities that are small businesses that may not have a facility registration number, the facility name/address may be submitted.  In addition to the mandatory information to be submitted (i.e., the facility registration number of each facility where the product is manufactured or processed, name and contact number of the responsible person, name of the cosmetic product, cosmetic category, ingredient listing, product listing number (if any) and type of submission), FDA requests submission of a list of optional information, including but not limited to parent company name (if applicable); type of business (manufacturer, packer, or distributor); image of the label; product webpage link.

The draft guidance describes the mandatory elements that must be included in the registration and listing.  For both the registration and listing, FDA describes optional information that FDA would like to get.  In addition, FDA requests that a party submitting the information, attest to the accuracy and veracity of the information submitted.”

FDA is developing an electronic portal for registration and listing submissions that will be available in October 2023.  On the same day that FDA issued the draft guidance, the Agency issued a request for (nine) volunteers to participate in a pilot program on the electronic registration and listing program.  Although FDA strongly encourages electronic registration, it is developing a paper form as an alternative to electronic registration.

FDA states that is intends to make relevant information from cosmetic product facility registration and listing available to the public to the extent permitted by law.  Under the law, FDA may not disclose the product listing number, registration number, and brand names under which cosmetic products are sold.

Comments on the draft guidance may be submitted until Sept. 7, 2023. (Instructions for submission of electronic and paper comments are included here).