On August 7, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance for registration of cosmetic facilities and products in compliance with the Cosmetics Regulatory Modernization Act of 2022 (MoCRA). This guidance provides key clarifications for companies in the cosmetics sector seeking to comply with new regulatory requirements.
Table of contents
FDA: Cosmetic Facility Registration
The FDA requires manufacturers and processors of cosmetic products intended for distribution in the United States to comply with a rigorous facility registration process. This step ensures proper oversight of products and strengthens safety in the marketplace. It is crucial for companies, even small ones, to understand the specific exceptions and rules to avoid noncompliance. Some of the products that require special attention include:
Those that come into contact with the mucous membrane of the eye.
Injectable products, regulated under additional regulations such as those of MoCRA Cosmetics.
Cosmetics for internal use.
Products that alter the appearance for more than 24 hours and cannot be removed by the consumer.
FDA: Deadlines
All facilities operating before December 29, 2022 must register on the Cosmetics Direct portal by December 29, 2023. Facilities opening after that date have 60 days from the start of operations or until February 27, 2024, as required by FDA MOCRA regulations. In addition, renewal is required every two years.
FDA: Updates
Changes to registered information, such as the address or owner of the facility, must be reported through the FDA Cosmetics Direct Registration platform within a maximum period of 60 days.
FDA: List of Cosmetic Products
Product listing is an essential step for manufacturers and distributors wishing to market cosmetics in the United States. This process, managed through the Cosmetics Direct Portal , allows the FDA to monitor the safety of products on the market.
FDA: Listing Contents
The product listing must include:
Product name and category.
Complete list of ingredients, including fragrances and flavors.
Facility registration number, obtained through the FDA Cosmetic Registration Search.
Contact details of the person responsible.
FDA: Submission Process
The FDA, under the MOCRA framework, has developed digital tools such as the Cosmetics Direct Portal to facilitate registration and listing submissions.
FDA: Establishment Identifier
The FDA Establishment Identifier (FEI) is essential for registration. Owners must obtain this number before starting the process in the FDA Cosmetics Direct Registration system.
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