Overview
This update is intended to assist owners or operators of cosmetic product facilities who are subject to requirements related to facility registration and responsible persons who are subject to requirements related to cosmetic product listing under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance document addresses the FDA’s compliance policy regarding these requirements. The FDA intends to delay enforcement of these requirements for six months to help ensure that industry has sufficient time to submit facility registration and product listing information.
Introduction
On November 8, 2023, the U.S. Food and Drug Administration (FDA) announced its intention to extend the enforcement deadline for cosmetic product facility registration and listing requirements as established by the Cosmetic Modernization Regulation Act of 2022 (MoCRA). The six-month extension is intended to provide industry with additional time to comply with the required facility registration procedures and provide detailed information on cosmetic products, thereby ensuring a smooth transition to the new regulations.
Requirements Enforcement announced
- The FDA does not intend to enforce the requirements related to cosmetic product facility registration and listing for an additional six months after the statutory deadline of December 29, 2023, or until July 1, 2024, to provide regulated industry with additional time to comply with these requirements.
- FDA does not intend to enforce the registration requirement for owners or operators of facilities that first engaged in the manufacture or processing of a cosmetic product after December 29, 2022, or the listing requirement for cosmetic products first marketed after December 29, 2022, until July 1, 2024.
New MoCRA authorities to the FDA:
- Facility registration: Manufacturers and processors of cosmetic products must register their facilities with the FDA, update the contents within 60 days of any changes and renew their registration every two years.
- Product listing: A responsible person must list each cosmetic product marketed with the FDA, including the product’s ingredients, and provide any updates annually.
Understand the Derogations:
Under the Modernization of Cosmetics Regulation Act (MoCRA), certain small businesses are exempt from the requirement of facility registration and product listing. However, these exemptions do not cover facilities involved in the manufacturing or processing, or individuals responsible for, specific cosmetic products:
- Products designed for regular contact with the mucus membrane of the eye under usual conditions of use.
- Injected products.
- Products intended for internal use.
- Products meant to alter appearance for over 24 hours, where consumer removal is not part of the usual conditions of use.
- Exemptions also apply to specific products and facilities subject to drug and device requirements.
Opportunity for Published Opinion 2023:
- In March 2023, the FDA issued a Constituent Update stating that submissions to the Voluntary Cosmetic Registration Program (VCRP) were discontinued due to the facility registration and product listing obligations mandated by MoCRA.
- In September 2023, the FDA introduced an opportunity for public input on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). The FDA strongly advocates for electronic submissions to enhance the efficiency and timeliness of data submission and management for the agency. Electronic submission, along with technical assistance documents and paper submission forms, is anticipated to be available in early December 2023.
Additional Information
Contact, Global Regulatory Partners at:
info@globalregulatorypartners.com
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Email: info@globalregulatorypartners.com
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References
Learn more about FDA. For the link, click here
Registration and Listing of Cosmetic Product Facilities and Products
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.