FDA extends deadline to facilitate compliance with MoCRA

The FDA has delayed the submission of the documents to ensure that industry has sufficient time to submit the documentation

10 of November of 2023
FDA

FDA gives cosmetics industry a reprieve. The US Food and Drug Administration (FDA) has announced that it will delay for at least half a year the implementation of facility registration and listing requirements for cosmetic products under the Modernization of Cosmetic Regulation Act (MoCRA).

This extension of deadlines is, as indicated by the FDA in a press release, to help ensure that cosmetic companies have sufficient time to submit facility registration and product listing information based on MoCRA requirements.

Prior to the amendment, companies had to comply with the amended regulation by 29 December. Now, according to the FDA's statement, the deadline has been extended to July 2024. However, despite this extended deadline, the agency has stressed that it is prepared to accept early filings and encourages companies to meet the previously established deadline. 

MoCRA will provide the FDA with new authorities on the following points:

  1. Registration of facilities: manufacturers and suppliers 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. 
  2. Product listing: The manufacturer, packager, supplier or distributor of the cosmetic product must list each cosmetic product marketed with the FDA, including the product's ingredients, and provide updates annually. 
  3. Exemptions: MoCRA exempts certain SMEs from the facility registration and product listing requirements. These exemptions do not apply to the facilities of companies that manufacture or supply, or supply, the following cosmetic products:
    • Products that regularly come into contact with the mucous membranes of the eyes under normal or abnormal conditions of use.
    • Products which are injectable.
    • Products that alter or change the appearance for more than 24 hours under normal or abnormal conditions of use and their withdrawal by the consumer is not part of these conditions of use.