Cosmetic manufacturers must comply with stringent regulations to market products in the United States, overseen by the FDA.
Regulatory Framework
The FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act), ensuring safety and labeling compliance.
Key Requirements
Manufacturers must register their facilities and products with the FDA, providing detailed ingredient lists and adhering to Good Manufacturing Practices (GMP).
Safety Assessment
Cosmetic ingredients are evaluated for safety, focusing on potential risks such as skin irritation or allergic reactions.
Labeling Standards
Accurate labeling is crucial, including ingredient lists in descending order of concentration and appropriate claims substantiation.
Global Harmonization
Efforts are ongoing to align U.S. regulations with international standards, facilitating global market access for compliant products.
Market Compliance
Ensuring FDA registration and compliance enables market access in the U.S., a crucial step for manufacturers aiming to reach American consumers.FDA OTC Registration