MoCRA Compliance Guide for Small Cosmetic Businesses
The FDA Modernization of Cosmetics Regulation Act (MoCRA) is the biggest change to cosmetic law in 85 years. Here's exactly what handmade soap, candle, and cosmetic makers need to do — without hiring a lawyer.
Key Deadlines
- • Facility registration: December 29, 2023 (past — register now if you haven't)
- • Product listing: July 1, 2024 (past — submit now if you haven't)
- • Serious adverse event reporting: 15 business days from receipt
- • Safety substantiation records: Must be maintained, no fixed deadline
Does MoCRA Apply to Me?
MoCRA applies to any person or company that manufactures, processes, packs, or holds cosmetics intended for U.S. consumers — including small Etsy and Shopify sellers.
You ARE covered by MoCRA if you:
- Make lip balms, lotions, soaps, scrubs, or any product applied to the body
- Sell handmade candles scented with fragrance oils that contact skin
- Sell cosmetics through Etsy, Shopify, Amazon, or at craft fairs
- Import finished cosmetic products for resale
Small business exemption (< $1M/year):
Businesses with average gross annual sales of under $1 million (for the last 3 years) are exempt from facility registration and product listing — BUT are still required to maintain safety substantiation records and report serious adverse events.
What You Need to Do
Register Your Facility
Required if revenue > $1M/yearRegister your facility with the FDA at the Cosmetics Direct portal. You'll receive an FEI (FDA Establishment Identifier) number. Registration must be renewed every 2 years (in odd-numbered years).
List Your Products
Required if revenue > $1M/yearSubmit a product listing for each cosmetic product you sell. The listing includes your product name, category, responsible person contact, and ingredient list in INCI format (descending order by concentration).
Maintain INCI Ingredient Records
Required for ALL makersEvery ingredient must be listed by its International Nomenclature of Cosmetic Ingredients (INCI) name, in descending order of concentration. This is required on your label AND in your FDA product listing.
Keep Safety Substantiation
Required for ALL makersYou must have records substantiating that your products are safe. This includes Safety Data Sheets (SDS) from ingredient suppliers, fragrance allergen information, and any safety assessments you've conducted.
Report Serious Adverse Events
Required for ALL makersIf a customer reports a serious adverse health event (hospitalization, permanent damage, death) related to your product, you must report it to the FDA within 15 business days. Keep detailed records of all complaints.
Understanding INCI Names
INCI (International Nomenclature of Cosmetic Ingredients) names are standardized ingredient names used worldwide. You must use INCI names on your product labels and in FDA listings.
Examples
Look up INCI names at CIR Safety or the EU CosIng database.
Stay Compliant with FormulaLedger
FormulaLedger tracks your INCI ingredient names, stores safety documents, generates your FDA-required ingredient list, and logs adverse events with automatic 15-day deadline tracking — all for $39/month.