Are you MoCRA Compliant?
Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
MoCRA is the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. This new law will help ensure the safety of cosmetic products many consumers use daily. The Consolidated Appropriations Act, 2023 contains the text of The Modernization of Cosmetics Regulation Act of 2022 in Division FF, Title III, Subtitle E, starting with section 3501.
MoCRA establishes the following new requirements for industry due by December 29, 2023:
Facility Registration: Manufacturers and processors must register their facilities (see definition below) with FDA and renew their registration every two years.
FDA has the authority to suspend a facility’s registration if the agency determines that a cosmetic product manufactured or processed by the registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans, and the agency has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility. If a facility’s registration is suspended, it is a prohibited act to distribute or sell (or otherwise introduce or deliver into commerce) in the United States cosmetic products from the facility.
Product Listing: A responsible person (see definition below) must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
Facility: any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States
Responsible Person: the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act
FDA stopped accepting and processing both electronic and paper submissions to the voluntary registration program for cosmetics establishments and products on March 27, 2023.
FDA issued draft guidance in August 2023 on cosmetic product facility registrations and product listings, as mandated by MoCRA. When finalized, the draft guidance will assist stakeholders with cosmetic product facility registration and product listing submissions to FDA.
Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products
As described in the draft guidance, FDA intends to use the FDA Establishment Identifier (FEI) as the required facility registration number. To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration. To determine if an entity already has an FEI number, please refer to the FEI Search Portal. If your firm does not have an FEI number assigned by FDA, see How can I request an FEI? at FEI Search Portal (fda.gov).
FDA is seeking comments on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). Cosmetics Direct includes the required registration and listing submission information from the paper forms in a standard electronic format. Draft screenshots of the electronic system are available for review and comments at FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products | FDA.
To comment on the draft guidance, submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with docket number FDA-2023-D-1716 as listed in the notice of availability that publishes in the Federal Register.
Please also see the link to the Modernization of Cosmetics Regulation Act of 2022 – Key Terms and Provisions webinar on theModernization of Cosmetics Regulation Act of 2022 | FDA website.
In addition, FDA is developing an implementation plan to address all of the new provisions in MoCRA and will share this information when available through additional communications on our Modernization of Cosmetics Regulation Act of 2022 | FDA website and other venues over the next few months. You may also wish to follow our social media, @FDACosmetics and @DrBumpusFDA on X (formerly Twitter), and subscribe to email updates at the Cosmetics News & Events | FDA Web page to stay up to date as we continue to make announcements related to this plan.