United States
Cosmetic Compliance
The US regulatory landscape has undergone its biggest shift in 80 years with the passing of MoCRA. Voluntary registration is now mandatory, and the FDA has new powers to recall products and inspect facilities.
On This Page
US Agent Required?
Foreign facilities must designate a US Agent for FDA communications.
MoCRA Overview
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) expands the FDA's authority over the cosmetic industry. It introduces mandatory facility registration, product listing, and serious adverse event reporting.
MoCRA Implementation Timeline
Dec 29, 2022
MoCRA signed into law.
Dec 29, 2023
Professional use labeling & adverse event reporting requirements effective.
July 1, 2024
CRITICAL DEADLINE: Facility Registration & Product Listing enforcement begins.
Dec 29, 2024
Contact information on labels requirement effective.
Dec 29, 2025
Fragrance allergen labeling requirements effective.
Small Businesses: Those with average gross annual sales of cosmetic products in the US for the previous 3-year period of less than $1,000,000.
Exemptions Apply To:
- Facility Registration
- Product Listing
- GMP Rules
Exemptions DO NOT Apply To:
- Safety Substantiation
- Adverse Event Reporting
- Labeling Rules
Facility Registration
Every facility that manufactures or processes cosmetic products for distribution in the US must register with the FDA. This applies to both US and foreign facilities.
What is a Facility?
Any establishment (including an importer) that manufactures or processes cosmetic products.
Who is NOT a Facility?
Warehouses, labeling/packaging only facilities, and retailers are generally exempt.
Product Listing
The Responsible Person must list each cosmetic product with the FDA, including its ingredients and where it is manufactured. Updates must be provided annually.
Required Information for Listing:
- Facility Registration Number (FEI)
- Product Name & Category
- Full Ingredient List (with UNII codes)
- Product Label Image
Safety Substantiation
Brands must maintain records supporting that their products are safe. This is a critical change. You can no longer rely solely on raw material safety data.
"Tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe."
— FDA Definition of Adequate Substantiation
- Microbiological Testing (USP 61/62)
- Preservative Efficacy (USP 51)
- Stability Testing
- Toxicological Risk Assessment
Our partner laboratory provides FDA-compliant safety substantiation packages including Stability, PET, and TRA.