MoCRA registration and listing explained for small brands
Updated October 31, 2026
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law on December 29, 2022. It is the biggest change to U.S. cosmetics law since 1938 and gave FDA new powers and new requirements for companies that make and sell cosmetics.
Who is the "responsible person"?
Under MoCRA, the responsible person is the manufacturer, packer or distributor whose name appears on the cosmetic product's label. If you sell a private label product with your brand on it, that is usually you, not your contract manufacturer.
Facility registration
Companies that manufacture or process cosmetic products for distribution in the U.S. must register each facility with FDA and renew the registration every two years. If you use a contract manufacturer, it registers its own facility. FDA accepts registrations through its Cosmetics Direct portal.
Product listing
The responsible person must list each marketed cosmetic product with FDA, including its ingredients, and provide any updates annually. This is the step that most often falls on a small brand.
Adverse event reporting
The responsible person must report serious adverse events associated with their cosmetic product to FDA within 15 business days, and include a copy of the label. Your label must also include a U.S. address, phone number or electronic contact where consumers can report adverse events.
Safety substantiation and records
The responsible person must make sure, and keep records showing, that there is adequate substantiation of each product's safety. Your formulator and testing labs can help you build that file.
The small business exemption
MoCRA exempts certain small businesses from facility registration, product listing and the coming GMP rules. Under the law, that generally means businesses with average gross annual U.S. sales of cosmetic products under $1,000,000 over the previous three years (adjusted for inflation). The exemption does not apply to makers of certain higher-risk products, including products that regularly contact the mucous membrane of the eye, injected products, products intended for internal use, and products meant to alter appearance for more than 24 hours. Small businesses still have to follow adverse event reporting, safety substantiation and labeling requirements.
What about pet grooming products?
MoCRA covers cosmetics, which U.S. law defines as products applied to the human body. Pet shampoos and grooming products are not cosmetics under that definition, but claims matter: products that claim to treat disease may be regulated as animal drugs by FDA, and products that claim to kill or repel fleas or ticks are generally regulated as pesticides by EPA (EPA: pets and pesticides). See our pet shampoo guide.
A checklist for small brands
- Confirm whether you qualify for the small business exemption, and whether your product types are excluded from it.
- Confirm your contract manufacturer's facility is registered.
- List your products (unless exempt) and set a yearly reminder to update them.
- Put an adverse event contact on every label.
- Keep a safety substantiation file for each product.
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