MoCRA: A New Era for Cosmetics Regulation
For decades, cosmetics were the least regulated consumer products in the United States. That changed dramatically with the Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022. For international beauty and personal care brands, MoCRA introduces significant new obligations that directly impact product labeling, safety, and market access.
Key MoCRA Requirements Affecting Labels
Facility Registration
Every facility that manufactures or processes cosmetics for the U.S. market must now register with the FDA. This includes international manufacturing facilities. Registration must be renewed annually and the facility is subject to FDA inspection.
Product Listing
Each cosmetic product marketed in the U.S. must be listed with the FDA, including:
- Product name and category
- Complete ingredient list
- Responsible person (U.S. contact)
Safety Substantiation
Brands must have adequate safety substantiation for every cosmetic product. While the FDA hasn't defined exactly what "adequate" means, at minimum you should have:
- Ingredient safety assessments
- Stability testing data
- Microbiological testing results
- Dermatological testing for skin contact products
Adverse Event Reporting
Serious adverse events must be reported to the FDA within 15 business days. Brands must maintain adverse event records for 6 years.
Cosmetic Label Requirements
U.S. cosmetic labeling requirements under the Fair Packaging and Labeling Act (FPLA) and FDA regulations include:
- Product Identity: The common or usual name of the product on the principal display panel
- Net Contents: Weight, measure, or count in both metric and U.S. customary units
- Ingredient Declaration: All ingredients listed in descending order of predominance using INCI nomenclature
- Warning Statements: Required for specific product types (e.g., sunscreens, products with certain allergens, aerosol products)
- Responsible Person: Name and address of the manufacturer, packer, or distributor
- English Language: All required label information must be in English (bilingual labels are permitted)
Drug vs. Cosmetic: The Critical Classification
The single biggest labeling mistake international beauty brands make is using claims that cross the cosmetic-to-drug boundary:
- Cosmetic Claims (OK): "Moisturizes skin," "Cleanses gently," "Adds shine to hair," "Improves appearance of fine lines"
- Drug Claims (NOT OK without FDA drug approval): "Treats acne," "Reduces wrinkles," "Cures eczema," "Anti-aging treatment," "Heals damaged skin"
Products making drug claims must comply with FDA drug regulations, including pre-market approval, clinical trials, and drug labeling requirements — a process that costs millions and takes years.
Common Label Compliance Issues
- Ingredient names not matching INCI nomenclature
- Missing or incorrect net content declarations
- Therapeutic or drug claims on cosmetic products
- Color additives not approved for intended use
- Missing fragrance allergen declarations (increasingly expected by retailers)
- SPF claims without OTC drug monograph compliance
How NPI's Label Review Helps
NPI's FDA Label Review service examines every element of your cosmetic or beauty product label against current U.S. requirements. Our team identifies compliance gaps, recommends corrections, and helps you avoid the costly delays that come from import detention or retailer rejection. Blueprint members receive their first label review free.
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