A significant increase in the U.S. was achieved through the introduction of several important provisions in the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. The FDA is responsible for regulating cosmetics. Some key aspects of MoCRA include:
- Mandatory Cosmetic Registration: Cosmetic manufacturers and packers are now required to register their establishments with the FDA and submit a list of the products they produce. This will provide the FDA with up-to-date information about the cosmetics market and enhance its ability to track products for safety purposes.
- Product Listing Requirements: Companies must list the products they manufacture or distribute with the FDA, providing more transparency into the ingredients used in cosmetics.
- Safety Substantiation: Manufacturers are now required to substantiate the safety of their cosmetic products and their ingredients before bringing them to market. This helps ensure that products are safe for consumer use and aligns with the FDA’s goal of protecting public health.
- Adverse Event Reporting: MoCRA mandates that cosmetic companies report serious adverse events linked to their products to the FDA. This allows the agency to monitor and respond to safety concerns in a timely manner.
- Good Manufacturing Practices (GMP): The law encourages companies to comply with good manufacturing practices, ensuring that cosmetics are produced under conditions that reduce the risk of contamination and support the overall safety of the products.
- Recall Authority: MoCRA grants the FDA the authority to order recalls for cosmetics that are deemed to be unsafe or violate other safety standards. Previously, the FDA only had limited recall authority for cosmetics.
- Labeling Requirements: The Act requires clearer labeling for cosmetics, including the provision of more detailed ingredient lists and product information, which will enhance consumer awareness and allow individuals to make informed choices.
- Increased Inspections: MoCRA authorizes the FDA to conduct more frequent inspections of cosmetic manufacturing facilities, ensuring compliance with safety and quality standards.
- Products that regularly come into contact with 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 is not part of such conditions of use.