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Impact of MoCRA on Cosmetic Industry

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly changes cosmetic product regulations. Let’s delve into its impact on the cosmetic industry:

Expanded FDA Authority: MoCRA is the most significant expansion of the FDA’s authority over cosmetics since the 1938 Federal Food, Drug, and Cosmetic (FD&C) Act was implemented. 

New MoCRA Compliance Requirements for Industry

Adverse Event Reporting: Responsible persons must report serious adverse events associated with cosmetic products within 15 business days. They must also include a copy of the product label.

Facility Registration: Cosmetic companies must register their manufacturing sites.

Safety Substantiation: Documentation supporting the safety of cosmetic products is required.

Labeling Changes: Compliance with labeling requirements is essential. Apart from FPLA and existing cosmetic labeling requirements, the product should comply with additional requirements such as the name of the person responsible, contact information for adverse event reporting, and professional use declaration. Also, the FDA is developing guidance on Fragrance allergen labeling requirements.

Good Manufacturing Practices Manufacturer has to comply with GMP requirements. However, currently, there is no requirement for pre-inspection of the facility.

Contact us if you have any questions on MoCRA registration and product listing.