MoCRA (Modernization of Cosmetics Regulation Act)
Establishment Registration: $649 USD / Per Year
Product Listing $399 USD / Each
MoCRA is the Modernization of Cosmetics Regulation Act of 2022 and was signed into law on December 29th, 2022. MoCRA is the largest reform of existing cosmetic regulations in the United States.
Under MoCRA, the term “facility” includes any establishment that manufactures or processes cosmetic products distributed in the United States. Facilities will need to register and comply with GMPs issued by FDA.
Small businesses will have more flexible and simplified requirements. FDA defines a small business as a business with average gross annual sales in the U.S. for the previous 3-year period of less than $1,000,000, adjusted for inflation. This does not apply to any responsible person or facility engaged in manufacturing cosmetic products that:
- Come into contact with eyes,
- Are injected,
- Are intended for internal use,
- Or alter the appearance for more than 24 hours under conditions of use that are customary or usual.
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