Short answer: if you own or operate a facility that manufactures or processes cosmetics for US distribution, you generally need to register that facility with FDA. The responsible person named on a marketed product's label generally needs to list that product. Foreign facilities must provide US-agent contact details in the registration. There are important exemptions, especially for certain small businesses, so begin by checking the FDA rules against your actual products and operation.
The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, added these requirements to US cosmetics law. This guide explains the practical sequence for brands based in the United States, China, and elsewhere; it is general information, not legal advice.
| Requirement | Who is responsible | Key point |
|---|---|---|
| Facility registration | Generally the facility owner or operator | Required registrations renew every two years; FDA ties the renewal date to the initial registration date. |
| Product listing | The responsible person named on the label | Each marketed cosmetic product is listed, including ingredients; listing updates are provided annually. |
| Foreign-facility contact | Foreign facility registrant | FDA's facility-registration form requires US-agent contact information for a foreign facility. |
| Exemption review | Facility owner / responsible person | Some small businesses and some products or facilities are exempt; exemptions have limits. |
The owner or operator of a facility that manufactures or processes cosmetic products for US distribution generally registers it with FDA. Registration is renewed every two years; FDA says the renewal date is based on the initial registration date. Before treating an operation as in scope, review FDA's current small-business and product-specific exemptions.
FDA accepts electronic submissions through Cosmetics Direct and also provides paper Form FDA 5066. For a foreign facility, the form requires the US agent's name, email (or N/A), and phone number. FDA's registration and listing are not an approval, certification, or promotional credential.
For each marketed cosmetic product, the responsible person submits the product listing. FDA defines that person as the manufacturer, packer, or distributor whose name appears on the product label. It is not automatically the importer or marketplace seller.
The listing includes product and ingredient information. FDA's current Form 5067 instructions identify these core items:
MoCRA exempts certain small businesses from facility registration and product-listing requirements. FDA also identifies limits to that exemption, including for products that contact the eye's mucous membrane, are injected, are intended for internal use, or alter appearance for more than 24 hours when consumer removal is not part of ordinary use. Drug- and device-regulated products and facilities can have different treatment. Do not assume an exemption from revenue or headcount alone.
FDA updated Cosmetics Direct and its materials in February 2026 to support biennial facility-registration renewals. The portal displays registration status and renewal date for registered facilities. Use FDA's current instructions before submitting, particularly if a prior registration or listing needs to be renewed, updated, discontinued, or relisted.
Anyone required to register a cosmetic product facility renews the registration every two years. FDA says the renewal date is based on the initial registration date; review the current portal instructions and any applicable exemption.
The responsible person is the manufacturer, packer, or distributor whose name appears on the product label. That person lists each marketed product, including ingredients, and provides updates annually.
No. Facility registration and product listing are regulatory submissions; they do not mean that FDA has approved the facility or cosmetic product. Marketing claims and labels still need separate review against applicable law.
This page provides general regulatory information, not legal advice. Check FDA's registration and listing page, Form FDA 5066 instructions, and Form FDA 5067 instructions for the facts of your submission.
KECC's MoCRA package covers facility registration plus five product listings for $899. Review the scope before requesting an assessment.
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