MoCRA: Draft Guidance issued by FDA – new submission portal announced for October

MoCRA: Draft Guidance issued by FDA – new submission portal announced for October

On 7^th August 2023, the US Food and Drug Administration (FDA) issued the draft guidance on cosmetic product facility registrations and products[1], following the Modernization of Cosmetics Regulation Act (MoCRA) passed by the Congress and signed by the President as part of the “Consolidated Appropriations Act” in the end of 2022[2],[3].

Notwithstanding certain exemptions for small businesses, MoCRA establishes the registration requirement for facilities (i.e. any establishments who manufacture and/or distribute cosmetic products in the US), to be submitted to the FDA. For non-US facilities, also the contact for the United States agent of the facility shall be submitted for facility registration.

In addition, the Responsible Person (i.e. the manufacturer, packer or distributor whose name appears on the label) must submit a Cosmetic Product Listing.

The guidance shall support any persons submitting facility registrations and cosmetic product listings. Among others, the document clarifies several aspects such as the responsibilities of certain parties, exact information to be included in the data submissions, etc. Comments on the current draft can be submitted to the FDA until 7^th September 2023.

The submission of information about existing facilities and listing of their cosmetic products will be required until 29^th December 2023.

The above deadline applies for facilities already operating in the US, and for cosmetic products placed on the US market before 29^th December 2022.

If facilities start operating after 29^th December 2022, they must be registered within 60 days of engaging, or by 27^th February 2024, whichever is later. Cosmetic products placed on the US market after 29^th December 2022 must be listed within 120 days.

The FDA will implement an electronic portal for facility registration and product listing, currently planned to be made finally available in October 2023[4].

For each facility registration, the FDA intends to use the FDA Establishment Identifier (FEI)[5] as the required identification number. If not available, responsible parties will need to obtain this FEI number by the FDA before submitting facility registrations (and product listing). If the facility is a small business exempted from facility registration, and do not need to obtain the FEI number, the facility name and address can be provided instead for product listing.

Before final implementation, a two-week-pilot program is announced by the FDA for evaluating the functionality of the new system, planned for beginning on 15^th September. Up to nine participants may then submit simulated submissions for cosmetic products. Interested parties may apply for this program by 22^nd August 2023[6].

[1] https://tinyurl.com/5b27a785

[2] https://mdsscosmetics.com/new-regulatory-requirements-for-cosmetic-products-in-the-united-states/

[3] https://www.congress.gov/bill/117th-congress/house-bill/2617/text

[4] https://tinyurl.com/2pnn7k94

[5] https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=portal.login

[6] https://tinyurl.com/5n7f463r