In the first two parts of this series (Part I and Part II), we provided an overview of the new US Food and Drug Administration (FDA) regulatory requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and the good manufacturing practices (GMPs) regulations FDA plans to establish. In Part III, we will review the new FDA draft guidance on the facility registrations and products listings as mandated by MoCRA.
For quick background, under MoCRA, cosmetic companies are required to register their facilities and list each product with FDA. While FDA previously had a voluntary cosmetics registration program, the agency ended the program as of March 27, 2023, and does not consider previous submissions to the voluntary registration program to satisfy the requirements under the MoCRA. On August 7, 2023, FDA issued a new draft guidance titled “Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products” to provide clarifications and instructions to assist the industry with cosmetic product facility registrations and product listings to FDA. As discussed in the draft guidance, FDA intends to make the new electronic submission portal available for submitting registration and product listing information in October 2023, and is also developing a paper form as an alternative. The agency further noted in the draft guidance that companies should plan to register and list well in advance of the December 29, 2023, statutory deadline. In addition, while 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 products is manufactured or processed, all other information from cosmetic product facility registration and listing would be available for public disclosure, in response to a Freedom of Information Act (FOIA) request.
Below, we further discuss the facility registration and product listing process as outlined by the FDA in the draft guidance.
In more detail
Cosmetic “Facility” Subject to Registration with FDA
For background, section 607(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) generally requires 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 to register each facility. In the draft guidance, FDA defines the term “manufacturing or processing of a cosmetic product” as “engaging in one or more steps in the making of any cosmetic product by chemical, physical, biological, or other procedures, including manipulation, sampling, testing, or control procedures applied to this product. Importantly, FDA clarifies that “facility” subject to registration with FDA under the MoCRA does not include any of the following:
- Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location.
- Cosmetic product retailers, including individual sales representatives, direct sellers (as defined in section 3508(b)(2) of the Internal Revenue Code of 1986), retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location.
- Hospitals, physicians’ offices, and health care clinics.
- Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer.
- Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services.
- Trade shows and other venues where cosmetic product samples are provided free of charge.
- An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale.
- An establishment that solely performs one or more of the following with respect to cosmetic products:
Information needed for MoCRA facility registration
To facilitate the registration process, the owner or operator of a facility will need to first obtain an FDA Establishment Identifier (FEI) number before submitting the facility registration. Other information required or recommended by FDA for facility registration includes the following:
FDA also requests that individuals submitting registration information to attest to the accuracy and veracity of the information submitted.
Information needed for MoCRA product listing
FDA noted in the draft guidance 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. Information required or recommended for product listing by FDA includes the following:
FDA also requests that individuals submitting product listing information to attest to the accuracy and veracity of the information submitted.
MoCRA facility registration and product listing compliance timeline
Every person that, on December 29, 2022, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States must register each facility no later than December 29, 2023. Further, the responsible person of a cosmetic product that is marketed on December 29, 2022, must submit a cosmetic product listing not later than December 29, 2023.
The FDA draft guidance further clarifies, however, that for every person that owns or operates a facility that first engages, after December 29, 2022, in manufacturing or processing of a cosmetic product for distribution in the United States, such facility must be registered within 60 days of first engaging in such activity or by February 27, 2024, whichever is later. Further, FDA expects the product listing for a cosmetic product first marketed after December 29, 2022 to be submitted within 120 days of marketing the product, or within 120 days of December 29, 2023, whichever is later.
- FDA intends to make the new electronic submission portal available for submitting registration and product listing information in October 2023. However, as the December 29, 2023 statutory deadline is quickly approaching, to minimize disruptions to trade, cosmetic companies should start collecting information needed for facility registration and product listing discussed in the FDA draft guidance.
- Regarding facility registration, cosmetic companies should conduct a thorough assessment to determine whether their cosmetic facility falls within the category of cosmetic facilities that are subject to registration under the MoCRA. This evaluation should take into account the specific nature of the operations conducted at the facility.
- The threshold question that every cosmetic company should address is whether they, or their partners, meet the criteria to be classified as “small businesses,” thus qualifying for certain exemption from the MoCRA facility registration and product listing requirements.
- Given that the information submitted to the FDA through facility registration and product listing could potentially be publicly available, companies need to carefully evaluate the necessity of disclosing optional information to the FDA that is not mandated by legal requirements.