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[FDA MoCRA Special Contribution #1] What is MoCRA? Brief Introduction



After 84 years, the FDA Modernization of Cosmetics Regulation Act (MoCRA) is being revised and is set to take effect on December 29, 2023.

Starting this October (less than two months away!!!), the FDA will be accepting

all relevant submission forms.

In light of this, Provision Consulting Group is publishing related content to raise awareness among cosmetics manufacturers, processing companies, brand companies, distributors, and related facilities about the importance of MoCRA and to help them prepare.


On August 7, 2023, the U.S. Food and Drug Administration (FDA) announced a draft guidance on the registration of cosmetic facilities and product listing in accordance with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).


Following the discontinuation of the Voluntary Cosmetic Registration Program (VCRP) in March 2023, the registration of cosmetic product facilities and product listing have become mandatory under MoCRA.


This guidance provides instructions regarding who is responsible for cosmetic facility registration and product listing with the FDA, information that should be included, submission methods, deadlines, and exemptions.


MoCRA is set to take full effect on December 29, 2023. Therefore, relevant stakeholders and businesses must plan and prepare for facility registration and product listing in advance.



Under MoCRA, the FDA will have the following authorities:


Facility Registration: Cosmetic product manufacturers and processors must register their facilities with the FDA, update information within 60 days of any changes, and renew registration every two years.


Product Listing: A Responsible Person must list each cosmetic product being marketed with the FDA, including product ingredients, and update this information annually.


Responsible Person: The term "Responsible Person" refers to the cosmetic manufacturer, packer, or distributor whose name appears on the label of a cosmetic product as required by section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.



Exemptions


Under MoCRA, certain small businesses are exempt from facility registration and product listing requirements.


The exempted small businesses must have an average annual gross sales of less than $1 million for cosmetic products within the United States over the past three years, and they must not engage in the manufacturing or processing of specific cosmetic products described in section 612(b) of the FD&C Act.


However, regulatory exemptions do not apply to businesses handling the following types of products:


  • Products that regularly come into contact with the mucus membrane of the eye under customary or usual conditions of use.

  • Products that are injected.

  • Products that are intended for internal use.

  • Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer are not part of such conditions of use.


This draft guidance also includes information about a new Portal for registration and listing.


Starting in October 2023, the FDA plans to make the new portal available. The FDA strongly encourages electronic submissions for efficient and timely data submission and management. Additionally, the FDA is developing paper forms as an alternative for submissions.


According to the draft guidance, the FDA intends to use the FDA Establishment Identifier (FEI) as the essential facility registration number. To streamline the registration process, facility owners or operators will need to obtain an FEI number before facility registration.


For detailed information, including requesting an FEI number or checking if you already have one, please refer to the FEI Search Portal.




The Responsible Person needs the facility registration number for product listing since it's required. Therefore, the Responsible Person must obtain an FDA Establishment Identifier (FEI) number for each facility where their cosmetic products are manufactured or processed.


For exempted small businesses without facility registration numbers, providing the facility name/address will suffice for product listing.


Please note that the FEI number is necessary for facility registration, which in turn is required for product listing.



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