FDA Requirements for Selling Food on Amazon USA

FDA Requirements for Selling Food on Amazon USA
Amazon Food Sellers — FDA Compliance Guide
Last updated:

FDA Requirements for Selling Food on Amazon USA

FDA compliance for Amazon food sellers comes down to one question: what is your role in the supply chain? If you import food — as most Amazon private label brands do — you are the U.S. importer of record and must maintain a Foreign Supplier Verification Program (FSVP), verify your supplier's FDA registration, file Prior Notice for every shipment, and ensure FDA-compliant labeling. If you operate a food facility (manufacture, pack, hold, or repack food), that facility must be FDA-registered. Amazon listing approval does not substitute for FDA compliance — and FDA violations create both import holds and Amazon account health risk simultaneously.
⚠ Sesame allergen update — January 2023: Sesame became the 9th major U.S. food allergen under the FASTER Act. All Amazon food listings containing sesame seeds, sesame oil, sesame paste, or tahini must include a sesame allergen declaration. Amazon has taken listing action on products with missing sesame declarations. This is the most common new compliance gap for Amazon food sellers in 2023–2026.
Your FDA Obligations by Role

The Two Amazon Food Seller Scenarios — and What Each Requires

Most Amazon food compliance problems start with sellers misidentifying their role. Here is the complete obligation map for each scenario:

📦 Scenario 1 — You Import Food

Most Amazon private label food brands. You source from a foreign manufacturer and import to Amazon FBA — directly or through a 3PL.

  • FSVP — written hazard analysis + supplier verification for every foreign supplier under 21 CFR Part 1 Subpart L
  • Supplier FDA registration — verify your manufacturer is registered and current (biennial renewal)
  • U.S. Agent — your foreign manufacturer must have one with a physical U.S. address
  • FDA-compliant labeling — Nutrition Facts, allergens (incl. sesame), ingredient list, English text
  • Prior Notice — filed before every shipment; consignee = you, not Amazon
🏭 Scenario 2 — You Operate a Food Facility

You manufacture, process, pack, repack, relabel, or hold food for U.S. distribution at your own facility — domestic or foreign.

  • FDA Food Facility Registration — required under 21 CFR Part 1 Subpart H before any food enters U.S. distribution
  • Biennial renewal — October–December of even years; missed renewal blocks all U.S.-bound shipments
  • U.S. Agent — required for all foreign-facility registrations
  • FSMA Preventive Controls — written food safety plan under 21 CFR Part 117
  • FDA-compliant labeling for all products distributed in the United States

Many Amazon sellers are both. A private label brand that imports products AND stores them at its own U.S. warehouse before shipping to Amazon FBA may need FSVP compliance as an importer AND facility registration for the domestic storage location if it repacks or relabels there. FDA Registration Assistance identifies which obligations apply to each part of your specific model.

A Common Confusion

Amazon's Own FDA Registration Does Not Cover Your Products

Amazon's fulfillment centers store food for distribution, which means Amazon itself maintains FDA food facility registrations for its FBA network as food holders. Many Amazon sellers assume this covers their compliance. It does not:

What Amazon's Registration Covers

Amazon's facility registrations cover Amazon's activity as a food holder — the physical act of storing food in its fulfillment centers. This is Amazon's own regulatory obligation for its own operations. It has no bearing on whether your manufacturing facility is registered, your labeling is compliant, or your FSVP is in place.

What You Still Need Separately

Your foreign food manufacturer must have its own separate FDA registration. You as the importer must have your own FSVP. Your products must carry FDA-compliant labels. Your Prior Notice must identify your manufacturing facility by its registration number. None of these are covered by Amazon's holding registration.

Labeling & The Sesame Risk

FDA Labeling Compliance — The Dual Risk of Amazon and FDA Enforcement

Labeling violations on Amazon food products create compounding risk: FDA enforcement at import or post-market AND Amazon account health action from customer complaints. The two enforcement paths are independent of each other — Amazon does not wait for FDA to act before taking listing or account action.

Missing Allergen Declarations

Undeclared allergens are the #1 cause of Amazon food listing holds and FDA import detentions. Nine major allergens must be declared: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame (effective January 2023 under the FASTER Act). A customer complaint about an undeclared allergen triggers both an Amazon listing investigation and potentially an FDA inquiry simultaneously.

Wrong Serving Size

The Nutrition Facts panel must use the U.S. Reference Amount Customarily Consumed (RACC) for the product category — not a European or home-country serving size. For example, the U.S. RACC for chocolate candy is 40g; for cooking oil it is 1 tablespoon (15mL). Wrong serving sizes affect every nutrient declaration on the panel and are a common import detention cause.

Foreign-Language Labels

All required label information — statement of identity, ingredient list, allergen declarations, directions — must appear in English. Labels in a foreign language only, or with English text below a non-U.S.-format Nutrition Facts panel, are non-compliant and will be detained at import. Amazon also requires English as the primary label language for U.S. listings.

Prior Notice — A Common Error

Prior Notice for Amazon FBA — Don't List Amazon as the Consignee

One of the most common Prior Notice errors for Amazon FBA sellers: listing Amazon as the ultimate consignee in the Prior Notice filing instead of the U.S. importer of record (the Amazon brand or company that owns the goods).

Who the Consignee Should Be

The ultimate consignee in FDA Prior Notice should be the U.S. importer of record — typically your Amazon brand's legal entity. This is the party responsible for FSVP compliance and the party to whom the food shipment is legally consigned at time of U.S. entry. The manufacturer must be the FDA-registered foreign food facility, not a trading company or freight forwarder.

What Happens When It's Wrong

An FDA Prior Notice listing Amazon or a freight forwarder as the manufacturer or consignee is an accuracy violation. Inaccurate Prior Notice triggers an FDA hold on the shipment — meaning your inventory sits at the port while detention fees accumulate and your FBA receiving appointment passes. FDA Registration Assistance reviews Prior Notice accuracy before every shipment.

Common Mistakes

7 FDA Compliance Mistakes That Derail Amazon Food Launches

1
No FSVP program Most Amazon private label food brands are U.S. food importers and are legally required to maintain an FSVP under 21 CFR Part 1 Subpart L. Operating without one is a regulatory violation — and FDA can inspect FSVP records at the port or at the importer's place of business.
2
Supplier's FDA registration expired or never completed Foreign food manufacturers must be FDA-registered. Biennial renewal is required October–December of even years. If a supplier's registration expires, every shipment from that facility can be detained — blocking new inventory from reaching Amazon FBA.
3
Missing sesame allergen declaration Sesame became the 9th major U.S. allergen under the FASTER Act effective January 1, 2023. Products containing sesame seeds, sesame oil, sesame paste, or tahini must declare sesame on the label. Amazon has taken listing action on products missing sesame declarations following customer complaints.
4
Nutrition Facts with non-U.S. serving size Foreign manufacturers often use European or home-country serving sizes that don't match the U.S. RACC for the product category. Wrong serving size makes every nutrient declaration on the Nutrition Facts panel non-compliant with 21 CFR Part 101.
5
Listing Amazon as the Prior Notice consignee The Prior Notice ultimate consignee should be the U.S. importer of record — the Amazon brand's legal entity — not Amazon. This is a common error that triggers FDA Prior Notice accuracy holds at the port.
6
Assuming the co-packer handles all FDA compliance A domestic co-packer maintains its own facility registration. But if you import the finished product or the ingredients, FSVP obligations and importer labeling responsibilities remain with you as the brand. The co-packer's compliance does not cover your import obligations.
7
Going live on Amazon before compliance is in place Amazon does not verify FDA compliance before accepting most food listings. But FDA enforcement happens at import — before the goods reach the listing stage. A product that launches without FSVP, compliant labeling, or supplier registration is non-compliant from day one, with every shipment at risk of detention.
Our Services for Amazon Sellers

Complete FDA Compliance Services for Amazon Food Sellers

FSVP Program Development & Agent Services Written FSVP programs built for Amazon private label importers — individual hazard analyses per supplier and product, supplier verification activities, corrective action procedures, 2-year recordkeeping. Fully inspection-ready. Managed as your supply chain evolves.
Supplier FDA Registration & Verification Verify that every foreign food supplier is FDA-registered and current. New registrations completed for unregistered suppliers. Biennial renewal tracked and managed for all suppliers in your program. Registration verification letters issued for Amazon compliance documentation requests.
Food Label Compliance Review Pre-shipment label review against 21 CFR Part 101 — Nutrition Facts format, U.S. RACC serving sizes, ingredient list order, English text, allergen declarations (FALCPA + FASTER Act sesame), and manufacturer information. Corrections identified before FDA sees the product.
U.S. Agent for Foreign Manufacturers Professional U.S. Agent service for your foreign food suppliers — FDA's official domestic contact for the facility. Assists with FDA communications, inspection coordination, and biennial renewal management. Name and contact on file in FDA's FURLS system.
Prior Notice Accuracy Review Review of Prior Notice submissions before every shipment — correct manufacturer registration number, accurate FDA product code, correct importer of record as consignee (not Amazon). Prevents the most common Prior Notice error causing FBA inventory delays.
Amazon Compliance Documentation Preparation of all FDA compliance documents that Amazon may request — facility registration letters, verification letters, FSVP documentation, and compliance attestations. Ready when Amazon asks so your listings are never disrupted by missing documentation.
Import Detention Resolution When a shipment is detained at a U.S. port, FDA Registration Assistance identifies the compliance issue, prepares the corrective response, and coordinates with your freight forwarder or customs broker for fastest release — minimizing FBA inventory disruption.
Ongoing Compliance Maintenance As your Amazon catalog grows, suppliers change, and products are reformulated, FDA Registration Assistance updates FSVP programs, reviews new labels, monitors supplier registration renewals, and manages all compliance changes — one partner for all FDA obligations.
Get Amazon-Ready

Ready to Sell Food on Amazon USA with Full FDA Compliance?

FDA Registration Assistance provides complete FDA compliance for Amazon food sellers — FSVP, supplier registration, U.S. Agent, label review, Prior Notice guidance, and Amazon compliance documentation — all managed as one coordinated program. 1,000+ clients. 135+ countries. 15+ years of FDA regulatory experience.

Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333.

FAQ

Frequently Asked Questions — FDA Requirements for Selling Food on Amazon USA

1. What FDA requirements apply to selling food on Amazon USA?

If you import food (most Amazon private label brands): FSVP for each foreign supplier; supplier FDA registration verification; FDA-compliant labeling; and Prior Notice for every shipment. If you operate a food facility: FDA Food Facility Registration with biennial renewal. Most sellers are importers with FSVP obligations.

2. Do I need FDA registration to sell food on Amazon?

The food manufacturing or processing facility needs FDA registration — not your Amazon seller account. Your foreign manufacturer must be registered under 21 CFR Part 1. If you operate a U.S. food facility, that facility must register. Your Amazon seller account itself does not require FDA registration.

3. Am I the importer of record for my Amazon private label food brand?

In most Amazon private label scenarios, yes — if your brand's entity appears on the CBP entry as the consignee. The importer of record bears the FSVP obligations under 21 CFR Part 1 Subpart L. If goods go through a 3PL that takes consignment first, the 3PL may be the importer of record. FDA Registration Assistance reviews your supply chain structure to confirm who bears the FSVP obligation.

4. Does Amazon's FDA registration cover my products?

No. Amazon maintains its own FDA food facility registrations for its fulfillment centers as food holders. This covers Amazon's holding activity only — not your manufacturer's registration, not your labeling compliance, not your FSVP. Your foreign food manufacturer needs a separate, independent FDA registration.

5. What documents does Amazon request for FDA compliance?

Amazon may request: FDA Food Facility Registration number or verification letter for the manufacturing facility; FSVP documentation; third-party lab test reports for certain categories (supplements, baby food); allergen compliance attestations; and product compliance documentation. FDA Registration Assistance prepares all of these documents proactively so they are ready when Amazon asks.

6. Can Amazon suspend my account for FDA compliance issues?

Yes. Amazon can restrict listings or suspend accounts when FDA compliance issues surface — particularly undeclared allergens triggering customer complaints, import detentions blocking inventory, or FDA Warning Letters or recalls associated with ASINs. A labeling violation creates both FDA enforcement risk and Amazon account health risk simultaneously.

7. What is FSVP and why does it matter for Amazon sellers?

FSVP under 21 CFR Part 1 Subpart L requires U.S. food importers to verify foreign suppliers meet FDA food safety standards — written hazard analysis, documented supplier verification activities, corrective actions, 2-year recordkeeping. As an Amazon brand importing food, you are typically a U.S. food importer. FDA inspects FSVP records — missing programs result in Form 483 observations and Warning Letters.

8. What is Prior Notice and how does it affect Amazon FBA?

FDA Prior Notice is required before every food import — 8 hours for ocean. For Amazon FBA, the Prior Notice ultimate consignee should be the U.S. importer of record (your brand) — not Amazon. Listing Amazon as the consignee is an accuracy violation that triggers FDA holds and delays FBA receiving.

9. Does my foreign food manufacturer need a U.S. Agent?

Yes. Foreign food facilities registered with FDA must designate a U.S. Agent with a physical U.S. address. Amazon sometimes requests confirmation of the U.S. Agent on file as part of compliance documentation. FDA Registration Assistance provides U.S. Agent services for foreign food manufacturers supplying Amazon sellers.

10. What labeling requirements apply to Amazon USA food products?

Under 21 CFR Part 101: English statement of identity; net quantity in U.S. units; current U.S.-format Nutrition Facts panel with correct RACC serving size; complete ingredient list in descending order; allergen declarations for all nine FALCPA and FASTER Act allergens (including sesame since January 2023); and manufacturer/distributor name and address.

11. Is sesame allergen declaration required for Amazon food products?

Yes. Sesame became the 9th major U.S. food allergen under the FASTER Act effective January 1, 2023. All Amazon food products containing sesame seeds, sesame oil, sesame paste, or tahini must include a sesame allergen declaration. Amazon has taken listing action on products missing sesame declarations following customer complaints.

12. What are the most common FDA compliance mistakes Amazon food sellers make?

Most common: no FSVP program; supplier FDA registration expired or never completed; missing sesame allergen declaration; Nutrition Facts with wrong U.S. serving size; listing Amazon as the Prior Notice consignee; assuming co-packer compliance covers all import obligations; and going live on Amazon before FDA compliance is in place.

13. What happens if my Amazon FBA food shipment is detained by FDA?

Detention fees accumulate daily; FBA receiving appointments are missed; inventory is delayed or refused entry; Amazon stock levels drop; and serious cases trigger Amazon account reviews. FDA Registration Assistance identifies the cause and prepares the corrective response for fastest possible release.

14. Does selling on Amazon remove FDA requirements?

No. FDA requirements apply based on your role (importer, manufacturer, distributor) — not your sales channel. Amazon being between you and the consumer does not remove facility registration, FSVP, labeling, or Prior Notice obligations.

15. If I use a co-packer, do I still have FDA obligations?

Yes — depending on your structure. Domestic co-packer: your brand label makes you the responsible firm. Foreign co-packer: you are typically the importer of record with full FSVP obligations. Imported ingredients: FSVP may apply to ingredient imports even if a domestic co-packer does the formulation.

16. Do dietary supplements sold on Amazon need different FDA compliance?

Yes. Supplement facilities must comply with cGMP under 21 CFR Part 111. Supplements use Supplement Facts panels. Health and structure/function claim rules differ from food. Amazon requires third-party test reports for certain supplement categories. New ingredients introduced after October 15, 1994 require a 75-day NDI notification to FDA.

17. What is the difference between Direct-to-FBA and 3PL-to-FBA for FDA compliance?

Direct-to-FBA: you are typically the importer of record with full FSVP obligations; Prior Notice consignee is you, not Amazon. 3PL-to-FBA: the 3PL may be the importer of record depending on the consignment structure, which could shift FSVP obligation. FDA Registration Assistance reviews your logistics structure to confirm Prior Notice and FSVP responsibilities.

18. How does biennial renewal affect my Amazon supply chain?

If your foreign food supplier's FDA registration expires, every shipment from that facility can be detained — blocking new inventory from reaching Amazon FBA. Suppliers may not notify brands when their registration expires. FDA Registration Assistance monitors and manages biennial renewal for all supplier registrations.

19. Can FDA Registration Assistance prepare my Amazon compliance documentation?

Yes. FDA Registration Assistance prepares all FDA compliance documentation that Amazon may request — facility registration confirmation, verification letters, FSVP documentation, supplier verification records, and label compliance attestations — so your documentation is ready when Amazon asks.

20. Does Amazon verify FDA compliance before allowing a food listing?

Amazon does not verify FDA compliance before accepting most food listings. However, Amazon may request compliance documentation at any point post-listing — during account review, in response to customer complaints, or during periodic category audits. The absence of upfront verification does not mean compliance is optional.

21. What is an FSVP Agent and do Amazon food sellers need one?

An FSVP Agent develops, implements, and maintains the FSVP program on behalf of the U.S. importer. Most Amazon private label food brands benefit from using an FSVP Agent — particularly those importing from multiple suppliers or those who have launched without any FSVP in place. FDA Registration Assistance serves as FSVP Agent for Amazon food sellers.

22. What happens if my supplier gets an Import Alert?

An Import Alert on your supplier causes DWPE — every future shipment is automatically detained. Existing Amazon FBA inventory is not immediately affected but cannot be replenished once sold out. FDA Registration Assistance advises on Import Alert remediation and alternative supplier qualification to minimize Amazon inventory disruption.

23. Do U.S.-based Amazon food sellers need a U.S. Agent?

The U.S. Agent requirement applies to foreign food facilities — not to the U.S. Amazon brand. If you are a U.S. brand importing from a foreign manufacturer, the foreign manufacturing facility needs a U.S. Agent. Your U.S. brand entity itself does not need one.

24. What services does FDA Registration Assistance provide for Amazon food sellers?

Complete FDA compliance: FSVP program development and Agent services; supplier FDA registration verification and management; U.S. Agent services; food label compliance review; Prior Notice accuracy review; Amazon compliance documentation preparation; import detention resolution; and ongoing compliance maintenance. 1,000+ clients. 135+ countries.

25. How do I get started with FDA compliance for my Amazon food brand?

Contact FDA Registration Assistance at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Provide your Amazon brand name, food products, foreign suppliers, countries of origin, and any existing compliance documentation. FDA Registration Assistance assesses your current compliance posture, identifies all gaps, and builds your complete FDA compliance program.

HM
Reviewed By Hector Matos, Senior Regulatory Compliance Specialist  ·  15+ years FDA compliance experience  ·  Published February 2026
Food and Drug Administration Contact Us for Assistance