Registration and listing requirements are old news for many FDA-regulated products, but FDA did not have authority to require cosmetic product listings or facility registrations until just recently.  FDA had a voluntary cosmetic registration process, but this did not provide the agency with a wholistic view of the industry.

The Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) provides registration and listing requirements for cosmetic products and cosmetic products facilities, which will go into effect later this year.¹ To address regulated industry’s concern about how FDA will implement these, FDA recently published a draft guidance, which describes MoCRA requirements regarding registration and listing, relevant exemptions from these requirements, and proposed timing for these changes.² We will provide an overview of notable points covered in the draft guidance and offer our observations. The agency is accepting comments on this guidance until September 7, 2023.³

Guidance Overview and Key Points

• The draft guidance aims to cover the following areas:
  • The statutory requirement to submit cosmetic product facility registrations and product listings
  • Relevant definition
  • Who is responsible for making the submissions
  • What information to include in the submissions
  • How to make the submissions
  • When to make the submissions
• The current voluntary cosmetics registration program ended on March 27, 2023, and information provided through that program will not carry over to the new system.
  • The information provided to satisfy the registration and listing requirements mandated under MoCRA differ from the information gathered under the voluntary program, so the information a company relied on for past submissions will likely not satisfy the new requirements.
• FDA intends to have an electronic submission portal available for registration and listing in October 2023.
  • While electronic submissions are preferable, FDA is developing a paper form as well.
• Registration is not required until December 29, 2023, or later:
  • Every person that, as of 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 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 U.S. must register such facility within 60 days of first engaging in such activity or by February 27, 2024, whichever is later.
  • 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, or, for a cosmetic product that is first marketed after December 29, 2022, within 120 days of marketing such product in interstate commerce.
  • 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.
• Registrations must be renewed every two years, and amendments to registrations must be updated within 60 days of any change to the information required for registration. Updates to product listings must be completed annually, including updates that a product is discontinued.
• The term “facility” has many exclusions. The following establishments do not fall under this term:
  • Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location
  • Cosmetic product retailers, including individual sales representatives, direct sellers, 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 healthcare 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
  • Establishments that manufacture or process cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale
  • Establishments that solely perform one or more of the following with respect to cosmetic products:
    • Labeling
    • Relabeling
    • Packaging
    • Repackaging
    • Holding
    • Distributing
  • Further, “small businesses” are exempt from registration and listing requirements. A “small business” under Section 612 of the Food, Drug, and Cosmetic Act (“the FD&C Act”) means responsible persons, and owners and operators of facilities, whose average gross annual sales in the U.S. of cosmetic products for the previous three-year period is less than $1 million (adjusted for inflation).
  • However, if a person or entity falls under this definition of “small business,” it will still be required to register or list if it engages in the manufacturing or processing of the following cosmetic products:
    • 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
    • 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
  • Persons engaged with both drug and cosmetic products may or may not have to register and list per both drug and cosmetic regulation:
    • If a facility manufactures or processes (1) drugs or medical devices; and (2) cosmetic products that are also subject to drug or device regulation under the FD&C Act, that facility only needs to register per drug or medical device-related requirements.
    • If a facility manufactures or processes (1) drugs or medical devices; and (2) cosmetic products that are not also subject to drug or device regulation under the FD&C Act, the facility must also register per the cosmetic product requirements.
    • Similarly, regarding product listing, if a product is both (1) a drug or medical device, and (2) a cosmetic product under the FD&C Act, a cosmetic product listing is not required to be submitted for such product.
  • The guidance provides an Appendix of appropriate cosmetic categories and codes required for product listing.
  • 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.
  • The product listing number will not be available for public disclosure. Even in response to a Freedom of Information Act request, 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.
  • There is no fee to submit a cosmetic registration or product listing.

AGG Observations

• Registration and listing requirements have been in place for many FDA-regulated products for a while, but the requirement for cosmetics is new.
• Unlike many other registration and listing submissions, the registration and listing for cosmetics, carries no fee (yet).
• Follow the guidance to gather the required information prior to registering or listing. It is best to have all of the information together prior to trying to enter the (yet to be developed) portal.
• Once the portal is available, do not wait until the last minute to register or list; give yourself time to complete the process in case any unexpected questions arise.

[1] MoCRA will also bring other requirements for FDA-regulated products labels as cosmetics, such as adverse event reporting, promulgation of regulatory GMPs, certain record keeping, certain label declarations, and provide FDA with the authority to initiate mandatory recalls of certain adulterated cosmetic products.

[2] The draft guidance is available here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products.

[3] The docket for submitting or reviewing public comments is available here: https://www.regulations.gov/docket/FDA-2023-D-1716.