Guide
Selling cosmetics on Amazon: what MoCRA actually requires of you
MoCRA is not an Amazon badge. Facilities that manufacture or process cosmetics for the US market register with FDA. The name on the label lists each product. A foreign facility also names a US agent. FDA does not issue a cosmetic certificate.
Updated 2026-08-24
Two filings, two different people
Under the Modernization of Cosmetics Regulation Act of 2022, manufacturers and processors register their facilities with FDA and renew every two years. A responsible person lists each marketed cosmetic product, including ingredients, and updates that listing annually.
Responsible person means the manufacturer, packer or distributor whose name appears on the label. For a typical Amazon private-label brand, that is often the brand on the bottle, not the factory and not Amazon. The factory still has to be registered if it manufactures or processes the cosmetic for the US market.
Foreign plants need a US agent
A foreign cosmetic facility registering with FDA must name a US agent: a person or firm that resides in the United States or maintains a US place of business and is physically present here. A mailbox, answering machine or answering service does not qualify.
FDA intends to use the FEI as the facility registration number. If the plant does not have an FEI, it has to obtain one before submitting the registration. Product listing then needs that facility registration number.
What still applies even if you think you are small
MoCRA exempts certain small businesses from facility registration and product listing. The exemption does not apply if you manufacture or process, or are the responsible person for, products that regularly contact the mucous membrane of the eye, products that are injected, products intended for internal use, or products intended to alter appearance for more than 24 hours where the consumer does not remove them as part of ordinary use.
Serious adverse events in the United States must be reported to FDA within 15 business days. That reporting duty sits on the responsible person. Do not read a registration exemption as a silence exemption.
FDA also says, without hedging, that cosmetic registration and listing is neither an approval programme nor a promotional tool, and that FDA does not issue certificates for those filings. “FDA certified” on an Amazon image is not something MoCRA gave you.
Renewal is tied to the day you first registered
A cosmetic facility renews every two years from the date of initial registration. If FDA received the first filing on 20 February 2024, the renewal is due by 20 February 2026. That calendar is not the food-facility window of 1 October to 31 December.
As of 30 June 2026 FDA reported 16,398 unique active facility registrations and 1,298,361 unique active product listings since 18 December 2023. The portal is Cosmetics Direct. Paper Forms 5066 and 5067 still exist; FDA asks people to file electronically.
What we file, and what it costs
FDA charges no fee for cosmetic facility registration or product listing. Our MoCRA cosmetic facility registration including one product listing is $549 in three business days. The MoCRA package, facility registration plus five listings plus one label check, is $999. Extra listings are $120 each. A year of US agent, if the facility is foreign, is $299.
Common questions
Does Amazon listing a cosmetic mean it is already listed with FDA?
No. Amazon’s catalogue is not Cosmetics Direct. The responsible person has to list the product with FDA.
Who is the responsible person if the factory’s name is on the box and my brand is on the bottle?
The responsible person is the manufacturer, packer or distributor whose name appears on the label under section 609(a) of the FD&C Act or the Fair Packaging and Labeling Act. Read the actual label. Do not guess from the purchase order.
Do I get a certificate to upload to Amazon after MoCRA registration?
No. FDA does not issue certificates for cosmetic facility registration or product listing.
Is a moisturizer a cosmetic or a drug?
Intended use decides. A moisturizer that only cleanses or beautifies is a cosmetic. A moisturizer that claims to treat eczema is being sold as a drug. Amazon copy can move the product across that line.
Do I still need a US agent if I already have a US LLC?
A US LLC does not replace the US agent on a foreign facility’s registration. If the plant is abroad, the plant names an agent. If the only facility is in the United States, there is no foreign-facility agent to name.
Sources
- FDA, Modernization of Cosmetics Regulation Act of 2022 (MoCRA) — facility registration, product listing, responsible person, adverse-event reporting, small-business limits — fda.gov
- FDA, Registration and Listing of Cosmetic Product Facilities and Products — FEI, no certificates, renewal from the initial date, Cosmetics Direct counts as of 30 June 2026 — fda.gov
- FDA, Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products — US agent for foreign facilities; mailbox does not qualify — fda.gov
- FDA, Is It Really 'FDA Approved'? — FDA does not approve cosmetics, other than colour additives — fda.gov
This guide is general information about MoCRA, not legal advice, and it does not create a client relationship. Registration and listing are not FDA approval. Confirm the filings that apply to your own label and plant before you rely on this page.
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