By Vincent Cruz
Amazon is where many foreign cosmetics brands first meet American customers. It is also where many first meet American regulation. Amazon runs its own approval and documentation checks, and behind those sits a federal layer that Amazon does not explain: FDA’s requirements under MoCRA.
This guide covers what a foreign brand needs, in FDA terms, to sell cosmetics on Amazon USA lawfully: facility registration, the U.S. agent requirement, product listings, labeling, and the pitfalls that get listings pulled. For the full compliance background, see the MoCRA Compliance Guide for Cosmetic Brands.
The two layers: Amazon’s rules and FDA’s rules
Selling on Amazon means satisfying two different authorities that do not coordinate with each other.
Amazon’s layer is about its marketplace policies: category approval (ungating) for beauty, documentation proving you are authorized to sell the products, and compliance with its restricted-products rules. Amazon can ask for invoices, authorization letters, and test reports, and it can suspend a listing at any time.
FDA’s layer is federal law. Under MoCRA, it applies whether you sell on Amazon, on your own site, or in a retail store. Amazon being your sales channel changes nothing about what FDA requires. The rest of this guide is about the FDA layer, because it is the one sellers most often discover too late.
What FDA requires from a foreign cosmetics brand
1. Facility registration
The foreign facility that manufactures or processes your cosmetics must be registered with FDA through the Cosmetics Direct portal (Form FDA 5066). This is the manufacturer’s obligation in most setups, but as the brand selling into the U.S., you need it done: an unregistered facility behind your products is a compliance gap that can surface at the port or in a retailer review. If you use a contract manufacturer, confirm in writing who handles the registration. See Private Label Cosmetics: Who Handles MoCRA Registration? for how duties split between brand and factory.
2. A U.S. agent for the foreign facility
Every foreign facility registration must designate a U.S. agent: a person or business physically present in the United States who serves as FDA’s contact for the facility. This is not optional, and a mailbox alone does not qualify. If you are evaluating providers, see How to Choose a MoCRA U.S. Agent and Who Can Be a MoCRA U.S. Agent?.
3. Product listings
Each cosmetic product sold in the U.S. must be listed with FDA (Form FDA 5067), filed by the responsible person, usually the brand owner. This is separate from facility registration and easy to miss: brands sometimes register the facility and assume the products are covered. They are not. See Facility Registration vs Product Listing.
4. Compliant labeling
MoCRA added labeling requirements on top of the long-standing ones: a domestic contact address, phone number, or electronic contact for adverse event reporting on the label, plus fragrance allergen disclosure where applicable. Labels also still need the basics: identity statement, net quantity, name and place of business, and ingredient declaration. Amazon will not check your label for you, but FDA can, and non-compliant labeling is one of the simplest things to get right in advance. See MoCRA Labeling Changes: What’s New.
5. Safety substantiation and adverse event systems
The responsible person must maintain records substantiating product safety and must report serious adverse events to FDA within 15 business days. These are ongoing obligations, not one-time filings. See MoCRA Safety Substantiation and MoCRA Adverse Event Reporting.
What Amazon may ask you for
Amazon’s beauty category approval typically asks for supply-chain documentation: invoices from authorized distributors, proof you are authorized to sell the brand, and sometimes compliance documentation for the products. Separately, Amazon may ask for evidence related to FDA compliance.
One thing to know: there is no such thing as an FDA certificate for cosmetics. FDA does not issue certificates, approval letters, or verification emails for facility registration or product listings. If Amazon (or anyone) asks for an “FDA certificate,” what you actually provide is your registration records: Submission IDs from Cosmetics Direct and your facility and listing records. We covered this exact situation for TikTok Shop sellers in TikTok Shop FDA Certificate Request: What to Do; the same logic applies on Amazon. Never buy a fake certificate from a third party. It will not survive scrutiny.
Common pitfalls for Amazon cosmetics sellers
Drug claims on the listing. This is the biggest one. Sunscreen, acne treatment, skin lightening with certain claims, and anything promising to change the structure or function of the body can push a product out of the cosmetic category and into drug territory, which has entirely different requirements. Amazon listing copy written for marketing impact (“heals,” “treats,” “SPF”) is where this usually happens. Keep cosmetic claims cosmetic.
Assuming the factory handled everything. Many Amazon sellers source from a manufacturer and assume registration, listing, and labeling are the factory’s problem. Under MoCRA, duties are split: the facility registers, the responsible person (often you, the brand owner) lists the products. Get the split in writing. See the private label guide.
No U.S. agent on file. Foreign sellers sometimes complete every other step and skip the agent, or name someone who does not actually qualify. The registration requires it. If your products are already selling and the facility has no agent, fix it now rather than after FDA comes asking.
Labeling done for another market. Labels designed for the EU, Korea, or China often do not meet U.S. requirements out of the box: missing domestic adverse-event contact, wrong ingredient naming conventions, net quantity formatting. Review labels against U.S. rules before your first shipment, not after a complaint.
Ignoring the small-business exemption question. Some small businesses are exempt from facility registration and product listing under Section 612 of the FD&C Act (21 U.S.C. Section 364h), but the exemption is narrow and does not cover every product type. Check whether you actually qualify with the small-business exemption worksheet instead of assuming.
How long does all this take?
The full sequence, facility registration plus product listings, realistically takes 3 to 4 weeks from a standing start, with the FEI request accounting for most of it. If you are planning an Amazon launch, start at least a month out. The detailed breakdown is in How Long Does MoCRA Facility Registration Take?.
What non-compliance can cost an Amazon seller
Beyond FDA enforcement, the Amazon-specific consequences are immediate: listing suspension, held inventory in FBA warehouses, and in the worst case, account-level action. A suspended listing during a launch window can cost more than the entire compliance process would have. For the enforcement side, see What Happens If You Don’t Register Under MoCRA? and FDA Detained Your Cosmetic Shipment?.
FAQ
Does Amazon require FDA registration to sell cosmetics?
Amazon has its own approval process and documentation requirements, which change over time. Separately, federal law under MoCRA requires facility registration, product listing, and a U.S. agent for foreign facilities regardless of sales channel. Satisfying Amazon’s checks does not satisfy FDA, and vice versa.
I sell through a U.S. distributor. Do I still need a U.S. agent?
The U.S. agent requirement attaches to the foreign facility’s registration, not to your distribution arrangement. A distributor can serve as the agent if they meet FDA’s requirements and agree to the role, but the requirement does not disappear because a distributor exists.
Can I sell on Amazon while my registration is pending?
FDA’s requirements apply to products marketed in the U.S.; there is no “pending” status that excuses non-compliance. Practically, many sellers start the process and launch in parallel, but understand the risk: the FEI wait cannot be expedited, so starting early is the only safe play.
Do I need separate registrations for each Amazon marketplace country?
MoCRA and FDA registration cover the United States only. Amazon’s other marketplaces (UK, EU, Japan) each have their own regulatory regimes. This guide covers U.S. requirements.
My products are made in the U.S. but my company is foreign. Do I need a U.S. agent?
The agent requirement applies to foreign facilities. If the manufacturing facility is in the U.S., no U.S. agent is required for that facility, though the facility must still register and products must still be listed. Confirm the facility’s actual location rather than the company’s.
What documents should I keep ready for Amazon’s review?
Keep your Cosmetics Direct Submission IDs, facility registration records, product listing records, U.S. agent designation details, and compliant label files in one place. When Amazon or anyone else asks for “FDA documentation,” this packet is what you produce.
Next step: Starting from zero? The FEI request is the longest step, so begin there: run the free FEI check to see if you already have one. Questions about your specific setup? Contact us.