FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products
On August 7, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance to assist cosmetics companies submitting cosmetic product listings and cosmetic product facility registrations to the agency. The agency characterized the guidance as playing a critical role in helping to ensure the safety of cosmetic products that many consumers use day-to-day.
Background
The growth in the cosmetics industry over the last several years prompted Congress to pass the Modernization of Cosmetics Regulation Act (MoCRA). in 2022. MoCRA modernizes and strengthens cosmetics regulations in the United States and gives the FDA additional authority. Key MoCRA requirements include:
- FDA registration for cosmetics facilities
- Product listings for each cosmetic product
- Adverse event reporting
- Safety substantiation
- Compliance with Good Manufacturing Practices (GMPs)
- Fragrance allergen labeling
MoCRA also gives the FDA new records access and mandatory recall authority. To assist companies in their MoCRA compliance efforts, the FDA has published new guidance answering key questions and providing recommendations.
Draft Guidance
The draft guidance for industry describes MoCRA requirements for facility registration and product listings, as well as the exemptions for certain small businesses. The guidance explains:
- The statutory requirement to submit cosmetic product facility registrations and product listings
- Definitions
- Who is responsible for making the submissions
- What information to include in the submissions
- How to make the submissions
- When to make the submissions
The document also answers key questions such as what to do if a product is both a drug and a cosmetic product and whether there are fees to submit a registration […]
The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of over the counter (OTC) drugs or cosmetic products must be aware of FDA’s various enforcement mechanisms, and more importantly, how to avoid and/or mitigate such actions. FDA’s most common enforcement activities include notices of FDA action, warning letters, seizures, voluntary recalls, injunctions, and criminal prosecution.