FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products

On August 8, 2023, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance regarding the Registration and Listing of Cosmetic Product Facilities and Products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) (Draft Guidance). MoCRA, which was signed into law in December 2022, provides FDA with significant new authority over the regulation of cosmetic products in the United States. The Draft Guidance is FDA’s first effort at implementing the many provisions of MoCRA. While a guidance document, unlike rulemaking, is not legally binding on FDA or regulated industry, the Draft Guidance closely follows MoCRA and thus contains important information for the cosmetic industry.

Although comments can be submitted on any FDA guidance at any time, to ensure that FDA considers comments prior to finalization of this Draft Guidance, electronic or written comments should be submitted to FDA no later than September 7.

Here is key information from the Draft Guidance:

1. New Requirements for Facility Registration

Who Must Register: Generally, every person that owns or operates a “facility” that engages in the manufacturing or processing of a cosmetic product for distribution in the United States must register with FDA. “Facility” and “manufacturing or processing of a cosmetic product” are defined in the Draft Guidance. There are several exceptions to the definition of “facility,” including beauty shops, salons, and retailers (unless they manufacture or process cosmetics) and establishments that solely perform one or more of the following with respect to cosmetic products: labeling, relabeling, packaging, repackaging, holding, and distributing. “Packaging” and “repackaging” do not include filling a product container, and therefore such activity triggers registration. There are also small business and other exemptions (e.g., for facilities registered under the law’s drug or device provisions).

Note also that if a facility manufactures or processes cosmetic products on behalf of a responsible person (i.e., a contract manufacturer), only a single registration is required for that facility, even if that facility also manufactures or processes its own cosmetics or manufactures or processes on behalf of more than one responsible person. A responsible person whose products are manufactured or processed at such facility may submit the facility registration for that facility. Under such an approach, the responsible person for the contract manufacturing facility would not need to register the facility. Information regarding the relationship between a contract manufacturer and a distributor or brand owner is something other industries have been cautious about sharing; understanding the implications of providing this information and obtaining clarity around how this will work in practice should be part of industry comments to FDA.

What Information Is Submitted:

• the name of the owner and/or operator of the facility
• the facility’s name, physical address, email address, and telephone number
• for any foreign facility, the contact information for the U.S. agent
• the facility registration number, if any, previously assigned
  • It is important to note that the facility registration number will be the FDA Establishment Identifier (FEI)
• all brand names under which cosmetic products manufactured or processed in the facility are sold
• the product category or categories (set forth in the Draft Guidance Appendix) and responsible person for each cosmetic product manufactured or processed at the facility
• type of submission (initial, amended, biennial renewal, or abbreviated renewal)

FDA is also requesting the submission of the following optional information:

• parent company name (if applicable)
• facility DUNS number
• additional contact information for individuals associated with the registration

A careful review of Appendix A is recommended as FDA is relying on these product categories, which may be too broad or not broad enough.

When Is Initial Registration Required:

• Every person who, on December 29, 2022, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the U.S. must register each facility no later than December 29, 2023.
• Every person who owns or operates a facility that first engages, after December 29, 2022, in manufacturing or processing of a cosmetic product for distribution in the U.S. must register such facility within 60 days of first engaging in such activity or by February 27, 2024, whichever is later.

2. New Requirements for Product Listing

Who Must List: For each cosmetic product, the “responsible person” must submit the product listing. “Responsible Person,” defined in MoCRA, means the manufacturer, packer or distributor whose name appears on the label of the cosmetic product. There are exemptions from listing requirements, including for small businesses and for combination cosmetic/drug or cosmetic/device products, previously listed.

What Must Be Listed:

• 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 cosmetic name as it appears on the label
• the applicable cosmetic category or categories for the cosmetic product
• a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under 21 CFR § 701.3 or by the ingredient common or usual name
• the product listing number, if any previously assigned
• type of submission (initial, update to content (annual), abbreviated renewal)

It should be noted that a single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.

FDA has also requested the inclusion of the following optional information:

• parent company name (if applicable)
• type of business (as listed on the label), that is, manufacturer, packer, or distributor
• image of the label
• 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
• additional contact information for individuals associated with the listing

When Is Initial Listing Required:

• The responsible person of a cosmetic product marketed on December 29, 2022, must submit a cosmetic product listing not later than December 29, 2023.
• The responsible person of a cosmetic product first marketed after December 29, 2022, must submit a cosmetic product listing within 120 days of marketing such product in interstate commerce or within 120 days of December 29, 2023, whichever is later.

FDA has requested that individuals submitting registration and listing information attest to the “accuracy and veracity” of the information submitted.

Among the uncertainties of product registration is whether FDA will treat product listing as a “ministerial” act or attempt to ascertain ingredient or other compliance with relevant regulatory provisions prior to accepting the listing. Similarly unknown is whether FDA will screen product listings for purported “drug” ingredients in such products. Would FDA refuse to list a cosmetic product on the basis of submitted listing information?

3. Combination Drugs/Cosmetics and Facilities That Manufacture/Process Drugs and Cosmetics

A cosmetic product that is also a drug is not subject to the MoCRA cosmetic listing requirements; it is subject to the drug listing requirements in the law. A facility that manufactures or processes cosmetic products that are also drugs is not subject to the MoCRA registration requirement unless it also manufactures or processes cosmetic products that are not also drugs. Such facilities are subject to the drug registration requirements in the law.

4. New Electronic Registration and Listing System

FDA is encouraging electronic submissions and is developing an electronic portal for submission and receipt of registration and product listing information. FDA is also developing a paper form as an alternative submission tool. The electronic submission portal, the paper form, and instructions for submission will be accessible at https://www.fda.gov/. FDA intends for the electronic submission portal to be available in October 2023. The Draft Guidance notes that FDA’s voluntary cosmetics registration program ended as of March 2023; information from that program will not be transferred to the new registration and listing system.

Cosmetic product facility registration and product listing will use the same electronic submission process as for registering a drug establishment and drug listing with FDA.

5. Disclosure of Registration and Listing Information

The product listing numbers will not be available for public disclosure. FDA will not disclose information from a facility registration regarding the brand names under which cosmetics 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 Freedom of Information Act (FOIA) request. All other information from cosmetic product facility registration and listing would be available for public disclosure consistent with the FOIA, 21 CFR Part 20, and other applicable federal law.