As noted in a previous post, there are a number of new regulations that cosmetic companies must comply with by December 29, 2023 as part of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The regulations that are effective at the end of 2023 include serious adverse event reporting, facility registration, product listing, and safety substantiation. In August, FDA published a draft guidance on the registration and listing processes.

The facility registration process requires that cosmetic companies first obtain a facility registration number a.k.a. an FDA Establishment Identifier (FEI). If a company was registered under FDA’s now defunct voluntary cosmetic registration program, the facility number used for that registration remains active for the new registration process.  Companies that need an FEI are directed to this website to obtain one.

While the cosmetic registration and listing portal is not available at this time, it is a good idea to understand the information that companies will have to submit by the end of the year:

Information Needed for Cosmetic Facility Registration:

  • the name of the owner and/or operator of the facility;
  • the facility’s name, physical address, email address, and telephone number;
  • with respect to any foreign facility, the contact for the United States agent of the facility (name and phone number), and, if available, the electronic contact information (email);
  • the facility registration number
  • all brand names under which cosmetic products manufactured or processed in the facility are sold;
  • the product category or categories (See Appendix A in the draft guidance) and responsible person for each cosmetic product manufactured or processed at the facility; and
  • type of submission (initial, amended, biennial renewal, or abbreviated renewal). All registrations initiated this year will be “initial” registrations.

In addition, FDA requests the parent company name (if applicable); the facility DUNS Number; and • additional contact information for individuals associated with the registration.

Information Needed for Cosmetic Product Listing (for each product):

  • the facility registration number of each facility where the cosmetic product is manufactured or processed;
  • the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;
  • the applicable cosmetic category or categories for the cosmetic product (refer to Appendix A below);
  • a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient;
  • the product listing number, if any previously assigned; and
  • type of submission (initial, update to content (annual), abbreviated renewal).

It is surprising and noteworthy that it will be optional to submit an image of the product label. Other optional information that FDA would like companies to provide with product listings includes  parent company name (if applicable); type of business (i.e., manufacturer, packer, or distributor); product webpage link; whether the cosmetic product is for professional use only; responsible person DUNS Number for address listed on product label; Unique Ingredient Identifiers (UNIIs); and  additional contact information for individuals associated with the listing.

Exemptions to Cosmetic Facility Registration and Product Listing:

Small businesses whose average gross annual sales in the U.S. of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, are exempt from cosmetic facility registration and product listing unless their products include:

  • Cosmetic products that regularly come into contact with mucus membrane 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.

It is also important for companies to know that the product listing number will not be available for public disclosure and that FDA will not disclose information from a facility registration on the brand names under which cosmetic products manufactured or processed in the facility are sold, or from a product listing on the facility registration number of the facility where the cosmetic product is manufactured or processed, in response to a request under the Freedom of Information Act (FOIA). All other information from cosmetic product facility registration and product listing is disclosable under applicable law.

Serious Adverse Event Reporting and Safety Substantiation:

FDA has not published guidance on serious adverse event reporting or cosmetic safety substantiation.  However, it may be helpful to read FDA guideline for consumers on what adverse events are.  It may also be informative to review FDA’s guidance on receiving serious adverse event reports for the dietary supplement industry.

FDA has always required that cosmetics on the U.S. market be safe.  The new safety substantiation requirement means that companies should review, update, and tabulate safety data for their products.  See also this information from FDA about cosmetic safety.

We will continue to update you on how to comply with MoCRA as information becomes available.  We look forward to October when FDA is set to roll out the portal for cosmetic registration and listing.  Meanwhile, contact us with your questions.