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1. Laws and Regulations
- Federal Food, Drug, and Cosmetic Act (FD&C Act): This is the primary legal framework that governs the safety and labeling requirements for cosmetics.
- Modernization of Cosmetics Regulation Act (MoCRA): A new act passed in 2022 that strengthens the regulation of cosmetics, including requirements for facility registration and adverse event reporting.
- Fair Packaging and Labeling Act (FPLA): Sets standards for the packaging and labeling of cosmetics.
2. Product Safety
- Safety Assessment: Cosmetic companies must ensure the safety of their products and ingredients, typically requiring evaluation by scientifically trained or experienced experts.
- Prohibited and Restricted Ingredients: Certain ingredients are banned from use, while others have usage restrictions.
3. Labeling Requirements
- Responsible Person Information: The label must display the name and address of the manufacturer, packer, or distributor.
- Ingredient List: All ingredients must be listed in descending order of predominance based on their concentration in the product.
4. Good Manufacturing Practices (GMP)
- GMP Compliance: All cosmetic production must follow GMP to ensure product safety and quality.
5. Adverse Event Reporting
- Reporting Requirements: Any health events related to the use of cosmetics must be reported to the FDA, especially serious adverse events.
These regulations aim to ensure the safety and effectiveness of cosmetics and protect consumer health. For more detailed information, you can refer to the FDA’s Cosmetics Guidance & Regulation page.
