FDA Requirements for Foreign Brands Selling on Amazon and Shopify

When to use this playbook

Your Amazon listing has been deactivated or flagged for FDA compliance documentation.
Your Amazon or Shopify store is ready, but you have not confirmed whether the foreign manufacturing facility is properly registered.
A marketplace has requested an “FDA certificate,” proof of registration, product testing, label images, or evidence of FDA clearance.
You sell cosmetics, dietary supplements, medical devices, or packaged foods made outside the United States.
Your first commercial shipment is approaching and you need to connect facility registration, the U.S. Agent, labeling, and import filings.

What success looks like

Each product is mapped to the correct FDA category, the responsible foreign facility has the required FDA record, and the evidence submitted to the marketplace answers its exact request. The submission does not call a private confirmation letter an FDA certificate or describe registration as FDA approval.

The two-track rule: FDA compliance and marketplace proof are different

An FDA requirement controls whether the facility, product, label, or shipment can legally enter the U.S. market. A marketplace requirement controls whether Amazon or another sales channel will allow the listing to remain active. One does not automatically satisfy the other.

Amazon can request testing, insurance, photographs, invoices, or third-party certifications that are not themselves FDA registration requirements. Conversely, an active Amazon listing does not prove that a foreign facility is registered, that its U.S. Agent accepted the designation, or that Prior Notice was filed for an incoming food shipment.

Marketplace policies checked October 2, 2026. Requirements can vary by ASIN, product subtype, and the request displayed in Seller Central. Sources: Amazon cosmetics policy, Amazon dietary supplements policy, Amazon medical devices policy, and Amazon food and beverages policy.
Product type	What Amazon typically asks the seller to produce	What FDA actually requires	Useful evidence
Cosmetics	English label images, Forms FDA 5066 and 5067 or registration and listing screenshots, and category-specific testing or manufacturing evidence.	Foreign facility registration, cosmetic product listing, compliant labeling, and a U.S. Agent for the foreign facility. The label must provide contact information through which the Responsible Person can receive adverse event reports.	Accepted facility registration, product listing records, complete label images, U.S. Agent confirmation, and any requested testing documents.
Dietary supplements	Full label images, an accredited third-party cGMP certificate, TIC validation or testing for notified ASINs, and insurance verification.	Food facility registration for covered manufacturing, processing, packing, or holding facilities; compliant supplement labeling; applicable cGMP compliance; and Prior Notice for imported shipments. FDA does not approve dietary supplements before sale.	Facility registration confirmation, Supplement Facts label, cGMP certificate, validated test records, and shipment-specific Prior Notice confirmation.
Medical devices	Establishment and device listing evidence, proof of 510(k) clearance or exemption where relevant, product photographs, labeling, and model identification.	Establishment registration, device listing, applicable premarket clearance or approval, compliant labeling, and UDI and GUDID records unless an exception applies.	FDA registration and listing database record, 510(k) or PMA record when required, exemption evidence, label images, and GUDID record.
Foods and beverages	English label images, manufacturer and supplier information, shelf-life information, and additional records for higher-control categories such as infant formula or baby food.	Registration of covered food facilities, compliant labeling, and Prior Notice before each imported shipment is offered for entry. FSVP is a separate importer obligation.	Facility registration confirmation, final label, supplier records, and Prior Notice confirmation for the shipment.

Shopify follows a different operating model. Its public compliance materials make the merchant responsible for regulatory compliance rather than treating store activation as FDA clearance. A live Shopify product page therefore does not replace any FDA registration, listing, labeling, U.S. Agent, or import requirement. See the Shopify compliance guidance.

Step 1: Capture the exact marketplace request before changing anything

Action: Save the complete compliance notice, including the ASIN or listing ID, issue category, requested documents, submission deadline, rejection reason, and every field displayed in Account Health. Download any document template that Amazon provides.

Expected outcome: You should be able to express the issue in one sentence, such as “Amazon wants MoCRA facility and product records,” “Amazon wants proof that this device is 510(k)-exempt,” or “Amazon classified the product as a dietary supplement and requires TIC validation.”

Gotcha: Do not begin with a generic registration certificate. Amazon routes different product categories through different workflows, including direct document submission and authorized testing, inspection, and certification providers. Amazon places current requests under Account Health and Product compliance requests, as explained in its compliance submission instructions.

Step 2: Identify the product category and the entity FDA regulates

Action: Map the seller, brand owner, manufacturer, packer, labeler, foreign facility, and U.S. importer. Then classify the product from its ingredients, intended use, label, website claims, and marketplace listing language.

Entity or record	Why it matters
Amazon or Shopify seller account	Controls the sales channel. It is not automatically the entity registered with FDA.
Foreign manufacturing or processing facility	This is commonly the entity that needs food, cosmetic, device, or drug establishment registration and a U.S. Agent.
Brand owner or cosmetic Responsible Person	May own the product listing and labeling obligations even when a contract manufacturer operates the registered facility.
Device labeler	Normally controls the UDI and GUDID record for the version or model placed on the U.S. market.
Food FSVP importer	Performs a separate supplier-verification function. This role is not automatically filled by the foreign facility’s U.S. Agent.

Expected outcome: You have a one-page entity map showing which company owns the marketplace account, which site manufactures the product, and which party owns each FDA filing.

Gotcha: A foreign brand can sell products made by a separate contract manufacturer. Registering the brand name does not correct a missing or inaccurate facility record for the actual manufacturing site.

Step 3: Build or repair the FDA record for the product type

Cosmetics under MoCRA

Action: Confirm the foreign manufacturing or processing facility registration, each cosmetic product listing, the U.S. Agent attached to the foreign facility, and the final U.S. label. The Responsible Person is the manufacturer, packer, or distributor whose name appears on the label. The label must include a domestic address, domestic telephone number, or electronic contact through which adverse event reports can be received.

Expected outcome: The facility, product, label, U.S. Agent, and Responsible Person records tell a consistent story. FDA explains these filings in its cosmetic registration and product listing guidance.

Gotcha: The U.S. Agent and Responsible Person are distinct roles. A single provider can support both, but appointing a Responsible Person does not by itself place a U.S. Agent in the foreign facility registration. See the MoCRA Responsible Person and U.S. Agent comparison.

Dietary supplements

Action: Confirm that covered facilities manufacturing, processing, packing, or holding the supplement are registered as food facilities. Review the Supplement Facts panel, ingredients, identity statement, responsible business information, domestic adverse-event contact, and all product claims. Assemble the manufacturing and testing evidence required by Amazon separately.

Expected outcome: The seller can prove facility compliance, label compliance, and marketplace testing without claiming that FDA approved or registered the supplement product. FDA confirms that dietary supplements generally do not receive premarket approval in its dietary supplement questions and answers.

Gotcha: Food facility registration is not dietary supplement product approval. Amazon’s cGMP certification, TIC validation, testing, and insurance requirements are additional channel requirements, not substitutes for the facility’s FDA record.

Medical devices

Action: Identify the device classification and product code, then confirm establishment registration, device listing, premarket status, labeling, UDI, and GUDID information. Foreign device establishments must identify a U.S. Agent as part of establishment registration.

Expected outcome: The evidence package connects the exact marketed model to its listing, premarket status, label, and device identifier. FDA explains the U.S. Agent requirement in its medical device U.S. Agent guidance and the identifier workflow in UDI Basics.

Gotcha: Establishment registration and device listing do not mean the device is FDA cleared or approved. A non-exempt device needs its applicable premarket record, while an exempt device needs evidence that the exemption matches the product and its intended use.

Foods and beverages

Action: Confirm the foreign food facility registration and U.S. Agent, review the U.S. label, identify the FSVP importer, and prepare Prior Notice for each shipment. Match the facility name, address, and registration data to the information used in import entry records.

Expected outcome: The facility-level registration and shipment-level filing are both complete before the goods are offered for import. FDA separates these requirements in its food import guidance.

Gotcha: Food facility registration does not cover a shipment. Prior Notice is a separate filing tied to the imported food and arrival, while FSVP is a separate supplier-verification obligation.

Step 4: Place the U.S. Agent in the facility record, not the marketplace account

Action: Determine whether the foreign manufacturing facility is subject to an FDA registration framework that requires a U.S. Agent. Enter and confirm that agent in the applicable FDA system.

Situation	Does the sales channel itself require an FDA U.S. Agent?	Where the U.S. Agent belongs
Opening an Amazon seller account	No	In the applicable foreign facility or establishment registration, not in the seller account merely because Amazon is the channel.
Opening a Shopify store	No	In the applicable FDA registration for the foreign facility.
Foreign food or supplement facility	The requirement comes from food facility registration.	The foreign facility’s FDA registration.
Foreign cosmetic facility	The requirement comes from MoCRA facility registration.	The foreign cosmetic facility registration.
Foreign medical device establishment	The requirement comes from device establishment registration.	The foreign establishment’s FURLS registration.

Expected outcome: The applicable FDA record identifies an active U.S. Agent that has accepted the designation, while the marketplace evidence packet identifies the same facility and registration.

Gotcha: The U.S. Agent does not automatically become the cosmetic Responsible Person, food FSVP importer, customs broker, Importer of Record, device initial importer, or owner of the marketplace account.

FDA Entry Point can serve as the U.S. Agent and coordinate facility or establishment registration, product listing, label review, food Prior Notice, cosmetic Responsible Person support, and device GUDID or UDI submissions through the same compliance relationship. Its operating scope is documented on the FDA Entry Point U.S. Agent and compliance services page.

Step 5: Build an evidence packet that does not overstate what FDA issued

Action: Assemble the official system evidence, provider confirmation, label, product records, testing, and shipment documents as separate files with clear names.

Evidence item	What it proves	What it does not prove
FDA registration number, accepted filing, status view, or searchable database record	Shows that a specific registration or listing record exists in the applicable FDA system.	Does not prove that the product is FDA approved, safe, effective, or compliant in every respect.
Forms FDA 5066 and 5067 or Cosmetics Direct screenshots	Connects a cosmetic facility and product to the MoCRA filing workflow.	Does not create cosmetic approval or endorsement.
Provider-issued confirmation letter	Explains what the provider filed, the facility covered, the U.S. Agent relationship, filing date, and available identifiers.	It is not an FDA-issued registration certificate and must not display itself as FDA approval.
Full label images	Shows the marketed identity, ingredients, responsible business, warnings, facts panel, claims, and contact information.	Does not prove that the facility registration, product listing, or import filing is active.
cGMP certificate or laboratory report	Addresses the manufacturing or testing standard named in a marketplace request.	Does not replace FDA facility registration or a category-specific product filing.
Prior Notice confirmation	Shows that FDA received advance notice for a specific imported food shipment.	Does not replace facility registration, FSVP, customs entry, or label compliance.

FDA does not issue food facility registration certificates. FDA also does not issue certificates verifying cosmetic facility registration or product listing, and device establishment registration does not denote product approval. A private confirmation letter can support a marketplace submission, but it should identify itself as provider-issued and be accompanied by the applicable FDA record. See the FDA registration certificate and U.S. Agent evidence guide.

Expected outcome: A reviewer can trace the marketplace listing to the label, product, manufacturing facility, FDA record, and any category-specific test or authorization.

Gotcha: Do not place the FDA logo on a private certificate, product image, or supplement listing. Do not use “FDA approved” unless the exact product has an applicable FDA approval or clearance that supports that wording.

Step 6: Submit the right evidence and recover a suspended listing

Action: Correct the underlying compliance issue before appealing. A polished letter cannot fix an expired registration, incorrect manufacturer address, missing product listing, unsupported device status, prohibited claim, or label that does not match the ASIN.

Identify the trigger. Determine whether the notice concerns registration, product classification, labeling, testing, claims, manufacturing evidence, or a mismatch between records.
Correct the source record. Update the applicable FDA filing, label, product detail page, or testing record. Keep the facility name and address consistent across every document.
Match each requested item. Create a document index that pairs every marketplace request with one file or a concise explanation.
Use the assigned submission route. Upload documents through Product compliance requests or initiate the required TIC workflow. Do not substitute a direct upload when Amazon requires third-party validation.
State the correction plainly. Explain what was wrong, what changed, and which attached record proves the correction. Avoid general claims that the company is “fully FDA certified.”

Expected outcome: The appeal answers the specific compliance notice and shows that the underlying record now matches the product being sold.

Gotcha: Opening repeated cases with different explanations can produce conflicting review records. Use one consistent facility name, product identity, classification, and evidence set.

For Shopify sellers

A Shopify store normally does not provide the same category approval signal as an Amazon compliance review. Keep the same evidence packet ready for payment-provider reviews, import questions, regulators, distributors, fulfillment partners, or a Shopify terms review. Shopify can remove products that violate the law or its applicable service terms, even when the storefront was previously active.

FDA Entry Point is the best fit when the seller needs more than an appeal letter

The marketplace request exposed a missing or inconsistent facility registration, product listing, U.S. Agent, label, Prior Notice, SPL, or GUDID record.
A founder has no dedicated regulatory hire and wants one team to connect the foreign factory, FDA record, label, shipment, and marketplace evidence.
The brand sells across more than one FDA category and wants food, cosmetic, device, or drug work coordinated under one relationship.
The current U.S. Agent only forwards messages and cannot help correct the filing or explain the evidence to a marketplace reviewer.

FDA Entry Point is not a fit when the issue is unrelated to FDA compliance

The Amazon suspension concerns intellectual property, account identity, customer reviews, inventory performance, or another non-FDA policy.
The FDA records and labels are already correct and the seller only needs routine navigation inside Seller Central.
The seller wants a document that presents a private provider certificate as FDA-issued or markets an unapproved product as “FDA approved.”

Frequently asked questions

Does selling on Shopify or Amazon require an FDA U.S. Agent?

Selling through Amazon or Shopify does not itself create a U.S. Agent requirement. The requirement attaches to the applicable foreign facility or establishment registration. Foreign food and supplement facilities, foreign cosmetic facilities, and foreign medical device establishments generally identify a U.S. Agent through their category-specific FDA filing. The agent belongs in that FDA record, not in the marketplace account merely because the product is sold online.

What FDA documentation does Amazon ask foreign sellers for?

Amazon requests category-specific evidence rather than one universal FDA certificate. Cosmetic requests can include Forms FDA 5066 and 5067, registration screenshots, labels, and testing evidence. Supplement requests focus on labels, accredited cGMP certification, TIC validation, testing, and insurance. Device requests can include registration, listing, premarket status, exemption evidence, and product photographs. Sellers should follow the exact request displayed in Account Health because requirements can differ by ASIN.

Do I need FDA registration to sell dietary supplements on Amazon?

The facility, not necessarily the Amazon account holder, generally needs FDA food facility registration if it manufactures, processes, packs, or holds dietary supplements for U.S. consumption. The supplement product itself does not receive routine FDA approval or product registration before sale. Amazon separately requires marketplace evidence such as full labels, third-party cGMP certification, TIC validation, testing for specified products, and insurance under its current dietary supplements policy.

Amazon suspended my listing over an FDA compliance issue. What should I do first?

Identify the exact claim or record that triggered the suspension before submitting an appeal. Check whether the problem is an expired or mismatched facility registration, missing product listing, unsupported “FDA approved” language, incorrect classification, label discrepancy, absent testing, or missing premarket evidence. Correct that source issue first, then submit a compact evidence set that maps every Amazon request to the corresponding record. Urgent facility, agent, and import problems may also require the workflow described in the urgent FDA compliance guide.

Is an FDA registration certificate supplied by a service provider official?

No, a provider-issued registration certificate or confirmation letter is not an FDA-issued certificate. FDA does not issue food facility registration certificates or certificates verifying cosmetic registration and listing, and device registration does not indicate product approval. A useful provider letter identifies the facility, filing, status, U.S. Agent relationship, and relevant record numbers while clearly stating that it is private confirmation. Supply it alongside the applicable FDA system evidence rather than presenting it as government approval.

Can my U.S. Agent also act as my MoCRA Responsible Person?

Yes, one provider can support both roles, but the U.S. Agent and MoCRA Responsible Person remain legally distinct. The U.S. Agent is attached to the foreign cosmetic facility registration and serves as the U.S. contact for FDA. The Responsible Person is the manufacturer, packer, or distributor whose name appears on the cosmetic label and carries product-level MoCRA responsibilities. Both roles and the label contact information should be documented explicitly rather than assumed from one appointment.