Why Amazon cares about MoCRA
Amazon is not the FDA, but it acts like a gatekeeper. When Amazon’s compliance team reviews a beauty listing — usually triggered by a new seller account, a customer complaint, or a category review — they can request proof that your manufacturing facility is registered with the FDA, product listing confirmations from FDA Cosmetics Direct, compliant labeling, and safety documentation for your formulas. If you can’t produce these, Amazon suppresses the listing until you can. For a brand doing launch-week volume, a two-week suppression is brutal.
The 6 things you need before you list
1. A US agent on file with the FDA
This is the step most foreign brands miss. If your manufacturing facility is outside the United States, the FDA will not complete your facility registration unless a US agent is designated — a person or company in the US that the FDA can reach. No agent, no registration. No registration, no proof for Amazon.
2. An FEI number for your facility
The FDA assigns every registered facility a Facility Establishment Identifier (FEI). If your facility has never registered, the FEI has to be requested first — this typically takes 7–10 business days. Don’t leave it to launch week.
3. Facility registration via Cosmetics Direct
Filed on FDA Form 5066 through the Cosmetics Direct portal. New facilities must register within 60 days of starting operations, and registration renews every two years.
4. A product listing for every SKU
Each cosmetic product needs a listing (Form FDA 5067) within 120 days of first marketing — with the ingredient list matching your label declaration (ingredients in descending order of predominance, per 21 CFR 701.3). A single listing can cover multiple products with identical formulations, or that differ only in colors, fragrances/flavors, or net quantity, so a 12-shade lipstick line can be one listing (21 U.S.C. §364c(c)(4)(B)). Submit updates to each product listing annually (21 U.S.C. §364c(c)(5)); report any change to facility registration information within 60 days (21 U.S.C. §364c(a)(4)). (This is general information, not legal advice.)
5. Compliant US labeling
Amazon checks labels too. Your packaging must show the responsible person’s name plus a domestic address, phone number, or electronic contact for adverse-event reports; a full ingredient declaration; and fragrance allergen labeling where required. Labels designed only for the Korean market almost always need rework.
6. An adverse-event process
Serious adverse events — hospitalization, disfigurement, and similar outcomes — must be reported to the FDA within 15 business days. You need an internal process to receive, log, and report them. Amazon customer complaints are often how brands first discover they need this.
The small-business question
Brands averaging under $1 million in gross US cosmetics sales over the previous three years are generally exempt from facility registration and product listing — but not from adverse-event reporting or labeling rules. And the exemption disappears entirely for products that (1) regularly contact the eye’s mucus membrane in normal use (e.g., eyeliners, eye makeup removers — not all eye-area makeup), (2) are injected, (3) are intended for internal use, or (4) are meant to alter appearance for more than 24 hours where the consumer doesn’t remove them as part of normal use (21 U.S.C. §364h(b)). If you’re unsure where you stand, run our free 2-minute eligibility checker.
What about your contract manufacturer?
Many K-beauty brands manufacture through an OEM/ODM in Korea. Only one FDA registration is needed per facility — filed either by the manufacturer or by you as the responsible person. Get it in writing: which country the facility is in, whether it’s already registered, and who its US agent is. If your manufacturer is already registered with a US agent on file, you may not need your own.
Timeline: work backwards from launch
8+ weeks out: designate your US agent and request your FEI number. 6 weeks out: file facility registration and product listings. 4 weeks out: finalize US-compliant labels and packaging. 2 weeks out: set up adverse-event intake and reporting. Launch week: keep your FDA confirmations somewhere you can send Amazon within 24 hours. The brands that get suppressed are almost always the ones that started this process after Amazon asked.
Get it handled
US MoCRA Agent acts as your designated US agent, requests your FEI, and files your facility registration — $450 one-time plus $34.99/month, with formal resignation (never silent abandonment) if you cancel. Start with the free eligibility checker or go straight to the intake form.