Importing beverages from Vietnam to the United States is one of the most commercially attractive sourcing decisions available to US distributors, wholesalers, and private label brand owners in 2026. The landed cost advantage over Chinese-origin equivalents, the tropical ingredient access, and the established shipping infrastructure from Ho Chi Minh City to West Coast ports are all well understood.
What is less understood — and where importers consistently lose time and money — is the FDA compliance layer that sits between a purchase order and a US retail shelf. A Vietnamese beverage manufacturer can produce a flawless product at a compelling price, but if the regulatory documentation is incomplete, the shipment stops at the port of entry. Detention Without Physical Examination (DWPE), Refusal of Admission, and FDA import holds are not rare events. They are the predictable outcome of incomplete compliance preparation.
This checklist is built specifically for US importers, distributors, and wholesalers evaluating or onboarding a Vietnamese beverage supplier. It covers every FDA requirement that applies to non-alcoholic packaged beverages from Vietnam in 2026, including two significant regulatory updates that took effect or were revised in the past twelve months. Work through each item before you place your first purchase order.

Why This Checklist Matters in 2026 Specifically

Two FDA regulatory developments in 2025 and early 2026 have changed the compliance landscape for beverage importers.
Prior Notice rule updated September 25, 2025. FDA finalized amendments to its Prior Notice regulations for imported food, adding new information requirements to the submission. Importers filing Prior Notice through ACE or the FDA Prior Notice System Interface (PNSI) must now ensure their submissions are current with the updated data field requirements. Shipments with incomplete or non-compliant Prior Notice are subject to hold at the port of entry, regardless of product safety.
FSMA 204 Food Traceability Rule compliance date extended. The original compliance date of January 20, 2026 for the FSMA Section 204 Food Traceability Rule has been extended by 30 months to July 20, 2028, following FDA’s March 2025 announcement and the close of the public comment period on September 8, 2025. However, FDA has confirmed that routine inspections against the rule will begin before the 2028 deadline. Importers sourcing beverages that contain ingredients on the FDA Food Traceability List (FTL) should begin building their traceability infrastructure now, not in 2027.
Import Alert 99-42 revised April 2025. FDA updated Import Alert 99-42 covering Detention Without Physical Examination for foods containing toxic elements including arsenic, lead, cadmium, and mercury. This alert applies to fruit juices and certain other beverage categories. Importers sourcing fruit juice from Vietnam must confirm their supplier conducts routine heavy metal testing with certified laboratory results per batch.
These changes mean FDA requirements importing beverages from Vietnam in 2026 are substantially different from previous years. This checklist reflects the current regulatory environment as of June 2026 and helps you meet FDA requirements importing beverages from Vietnam effectively.

The Complete FDA Compliance Checklist for Importing Beverages from Vietnam

Requirement 1 — FDA Food Facility Registration (21 CFR Part 1, Subpart H)

What it requires: Every foreign facility that manufactures, processes, packs, or holds food or beverages destined for US consumption must register with FDA under Section 415 of the FD&C Act. Registration must be renewed every even-numbered year during the October 1 to December 31 renewal window. An expired registration renders the facility non-compliant and all shipments from that facility subject to refusal of admission.
Since the FDA Budget Reconciliation update of 2024, FDA requires a Unique Facility Identifier (UFI) — currently the DUNS number — linked to each registration. A registration without a valid, matching DUNS is treated as incomplete.
What to verify before your PO:
  • Request the ten-digit FDA registration number from your supplier
  • Confirm the most recent biennial renewal date (most recent: October to December 2024)
  • Verify the DUNS number matches the FDA registration record
  • Cross-check directly at the FDA Food Facility Registration query portal at fda.gov — do not rely solely on a supplier-issued certificate
  • Confirm the US Agent named in the registration is current and reachable
Why it fails in practice: Suppliers whose registration lapsed during the October to December 2024 renewal window and did not renew are operating with an invalid registration as of January 2025. FDA and CBP share registration data — an invalid registration will cause an automatic hold at entry, not a warning.
Interfresh status: Active FDA Food Facility Registration. Biennial renewal completed October to December 2024. DUNS number available on request. US Agent contact confirmed.

Requirement 2 — Foreign Supplier Verification Program (FSVP) (21 CFR Part 1, Subpart L)

What it requires: Under FDA requirements importing beverages from Vietnam, the US importer of record is legally responsible for the FSVP. The FSVP is the US importer’s legal obligation under FSMA — not the foreign manufacturer’s. The US importer of record must develop and maintain a written FSVP for each foreign supplier and each food they import. The FSVP must include four documented components: a written hazard analysis, a supplier evaluation, defined verification activities, and records retained for a minimum of two years.
A point that consistently trips up first-time importers: your customs broker is not automatically your FSVP importer. The FSVP importer must be explicitly designated at CBP entry. If your customs broker files entries but has not been named as FSVP importer and accepts that legal responsibility in writing, the importer of record is exposed to enforcement action even if the broker is handling all logistics.
What to verify and prepare:
  • Designate your FSVP importer explicitly — typically the US buyer, consignee, or a designated compliance entity
  • Complete a written hazard analysis for each SKU you import from Vietnam
  • Conduct and document a supplier evaluation using your Vietnamese supplier’s HACCP plan summary, ISO 22000 certificate, and Certificate of Analysis from recent production runs
  • Define your ongoing verification activities: at minimum annual supplier questionnaires plus COA review per batch for low-risk shelf-stable beverages
  • Retain all FSVP records for two years and be prepared to provide them to FDA within 24 hours of request
What Interfresh provides to support your FSVP under FDA requirements importing beverages from Vietnam:
  • Current ISO 22000 and HACCP certification documents with issuing body, scope, and expiry date
  • HACCP plan summary for the beverage categories you order
  • Per-batch Certificate of Analysis from a third-party accredited laboratory
  • Completed supplier questionnaire template for your FSVP file
  • Recent FDA inspection history and any corrective action records

Requirement 3 — Prior Notice of Imported Food (21 CFR Part 1, Subpart I)

What it requires: FDA requires electronic Prior Notice for every shipment under FDA requirements importing beverages from Vietnam — including samples — before the shipment arrives at a US port of entry. This requirement was updated September 25, 2025, with additional data field requirements now in effect.
Timing windows:
  • Ocean freight: file between 8 hours and 5 days before the vessel’s estimated arrival at the first US port
  • Air freight: file between 4 hours and 5 days before scheduled landing
  • Courier shipments (DHL, FedEx, UPS): file before the courier departs the origin country — meaning for Vietnam-origin shipments, Prior Notice must be on file before the package leaves Ho Chi Minh City
Required data fields (current as of September 2025 amendments):
  • Precise product description and FDA product code
  • Manufacturer name and FDA registration number
  • Country where grown or raised (Vietnam) and country of processing (Vietnam)
  • Shipper name and address
  • Anticipated arrival information including port and date
  • For any product previously refused entry anywhere in the world: the country of refusal must now be declared
Common Prior Notice failures: Wrong FDA product code, mismatch between the declared manufacturer and the FDA registration holder, missing country of origin for ingredients, and failure to update for delayed vessels. Any of these triggers a hold requiring FDA review before release — a process that takes a minimum of 24 to 72 hours and generates demurrage charges.
Interfresh’s role: Interfresh provides all required supplier information for Prior Notice completion: FDA registration number, product descriptions, manufacturing country, and ingredient origin. Prior Notice filing itself is the importer’s responsibility and is typically handled by your licensed US customs broker.

Requirement 4 — Juice HACCP (21 CFR Part 120) — Applies to Fruit Juice and Blended Products

What it requires: Any facility manufacturing fruit or vegetable juice products destined for the US market must operate under a HACCP plan compliant with 21 CFR Part 120. This applies to single-strength juices, juice blends, and beverages containing more than a de minimis amount of fruit or vegetable juice as a characterizing ingredient. This is distinct from and additional to general food safety HACCP requirements.
Juice HACCP requires the facility to achieve a 5-log reduction in the relevant pathogen (typically Salmonella for citrus, Cryptosporidium for apple juice, E. coli for other juices) through a validated process.
Verification required: Request documentation from your Vietnamese supplier that their Juice HACCP plan has been developed, implemented, and verified for the specific juice products you are importing. A general HACCP certificate covering the facility does not substitute for a product-specific Juice HACCP plan under 21 CFR Part 120.
Beverage categories affected at Interfresh: Fruit juice-based beverages, passion fruit drinks, guava juice, aloe vera drinks with juice content, and any blended beverages where juice is a characterizing ingredient. Full documentation is available to support your compliance with FDA requirements importing beverages from Vietnam.

Requirement 5 — Low-Acid Canned Foods and Acidified Foods (21 CFR Parts 108, 113, 114) — Applies to Canned Beverages

What it requires: Beverages processed in hermetically sealed containers (including aluminum cans) with a finished equilibrium pH above 4.6 and a water activity above 0.85 are regulated as Low-Acid Canned Foods (LACF) under 21 CFR Part 113. Beverages that have acid added to achieve a finished equilibrium pH of 4.6 or below are regulated as Acidified Foods (AF) under 21 CFR Part 114.
For both categories, the foreign manufacturer must:
  • Register their establishment with FDA on Form 2541 (LACF/AF registration — this is separate from and in addition to the general food facility registration)
  • File their scheduled process on FDA Form 2541a, 2541c, 2541d, or 2541e as appropriate for the processing method
  • Have the scheduled process established by a qualified process authority
Why this catches importers off guard: A Vietnamese supplier may hold a valid general food facility registration but have not filed the required LACF/AF scheduled process registration for their canning line. FDA can refuse admission of canned beverages from facilities that have not filed, regardless of the product’s actual safety.
What to verify: For any product packed in aluminum cans or glass jars, ask your supplier specifically: “Have you filed your LACF or Acidified Foods scheduled process with FDA on Form 2541 series?” Request the FDA process filing acknowledgment number.
Interfresh status: LACF and Acidified Foods scheduled process filing current with FDA for all canned beverage production lines.

Requirement 6 — US Food Labeling Compliance (21 CFR Part 101)

What it requires: Every beverage sold in the US market must carry label information compliant with FDA 21 CFR Part 101. For imported beverages, the label must be present on the retail unit before it is offered for sale — not applied after customs clearance.
Critical labeling requirements for 2026:
Nutrition Facts panel format: The updated Nutrition Facts format (mandatory since January 2020) must be used. Added sugars must be declared separately from total sugars. Serving size must reflect realistic consumption amounts under FDA’s updated reference amounts customarily consumed (RACC).
Allergen declarations under FALCPA and the FASTER Act: All nine major allergens must be declared — milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Sesame was added effective January 1, 2023 under the FASTER Act. Any Vietnamese beverage containing sesame oil, sesame seeds, or sesame-derived ingredients must carry a sesame allergen declaration. Failure to declare sesame is now one of the most common misbranding violations for imported beverages.
Net content dual units: Net weight or volume must be expressed in both metric and US customary units on the principal display panel.
Country of origin: “Product of Vietnam” must appear on the label. This is both an FDA misbranding requirement and a CBP marking requirement.
Statement of identity: A product must bear a statement of its common or usual name in English.
Ingredient list: All ingredients must be declared in descending order by weight with standardized names. Ingredients used in sub-ingredients must be fully declared. This is particularly relevant for Vietnamese beverage formulas that may use flavor compounds or composite ingredients.
Interfresh label service: Interfresh’s in-house design team produces label artwork built from 21 CFR Part 101 compliance requirements outward — not adapted from a generic template. US Nutrition Facts panels, FASTER Act allergen declarations, and dual-unit net content are standard. Pre-production proof review is provided for every new label.

Requirement 7 — FSMA 204 Food Traceability Rule — Prepare Now, Comply by July 2028

What it requires: The FSMA Section 204 Food Traceability Final Rule requires businesses that manufacture, process, pack, or hold foods on the FDA Food Traceability List (FTL) to maintain records of Key Data Elements (KDEs) at Critical Tracking Events (CTEs) and provide those records to FDA within 24 hours of request.
The current timeline: The compliance date has been extended from January 20, 2026 to July 20, 2028, following FDA’s March 2025 announcement. Routine inspections are expected to begin before the 2028 deadline. FDA hosted a public meeting on June 15, 2026 to discuss lot-level tracking flexibilities.
Does this apply to most Vietnamese beverages? Most packaged shelf-stable non-alcoholic beverages (coconut water, aloe vera drinks, fruit juice in cans and Tetra Pak) are not currently on the Food Traceability List in their finished packaged form. However, if your beverage contains a FTL ingredient in the same form in which it appears on the list (for example, fresh tropical fruit as a characterizing ingredient rather than processed juice concentrate), traceability requirements may apply.
Action for US importers now: Records are readily available to help you meet FSMA 204 requirements under FDA requirements importing beverages from Vietnam.

Requirement 8 — Import Alert Status Check

What it requires: Before importing from any Vietnamese supplier, verify that neither the supplier facility nor the product category is subject to an active FDA Import Alert that would result in Detention Without Physical Examination (DWPE).
Active import alerts relevant to Vietnamese beverages:
Import Alert 99-32 covers facilities that have refused or failed to respond to FDA inspection. Any Vietnamese beverage manufacturer on the Red List of this alert has their products subject to DWPE at all US ports of entry. Verify at accessdata.fda.gov/cms_ia/country_VN.html.
Import Alert 45-07 covers beverages and juice products containing undeclared saccharin or cyclamate. At least one Vietnamese food facility was listed on this alert for juice products as of 2025. Undeclared non-nutritive sweeteners in beverages are both a misbranding violation and an adulteration issue under this alert.
Import Alert 99-42 (revised April 2025) covers foods with toxic element contamination including arsenic, lead, cadmium, and mercury. Fruit juice importers must verify their supplier conducts heavy metal testing per batch against FDA action levels.
Interfresh status: No active import alerts. No DWPE. Regular FDA inspection history available for review on request.

Summary Compliance Checklist

RequirementRegulationImporter ActionNotes
FDA facility registration21 CFR Part 1, Subpart HVerify at fda.govCheck renewal + DUNS
FSVP program21 CFR Part 1, Subpart LBuild written programImporter’s legal obligation
Prior Notice21 CFR Part 1, Subpart IFile via ACE/PNSIUpdated Sep 25, 2025
Juice HACCP21 CFR Part 120Request plan from supplierFruit juice products only
LACF / AF filing21 CFR Parts 113/114Request Form 2541 filingCanned beverages
US label compliance21 CFR Part 101Review pre-production proofSesame allergen added Jan 2023
FSMA 204 traceabilityFSMA Section 204Assess FTL applicabilityCompliance deadline July 20 2028
Import alert checkFD&C Act Section 801Search accessdata.fda.govBefore every new supplier

FAQs

Q: What FDA certifications does a Vietnamese beverage manufacturer need to export to the USA? The manufacturer must hold an active FDA Food Facility Registration with a valid DUNS number. For juice products, a compliant HACCP plan under 21 CFR Part 120 is required. For canned beverages, Low-Acid Canned Foods or Acidified Foods scheduled processes must be filed. ISO 22000 and HACCP certifications help support your FSVP under FDA requirements importing beverages from Vietnam.
Q: What is an FDA Import Alert and how does it affect my beverage shipment? An FDA Import Alert allows port inspectors to detain shipments without physical examination (DWPE) due to repeated non-compliance. Affected shipments are held until compliance is proven, often causing long delays and high demurrage costs. Checking the FDA Import Alert database is essential before working with any Vietnamese supplier under FDA requirements importing beverages from Vietnam.
Q: Is my customs broker responsible for FSVP compliance? No. FSVP is the legal responsibility of the US importer of record under FSMA. Your broker may handle entries and Prior Notice, but unless they are formally designated as the FSVP importer in writing, you remain fully liable. Many importers designate themselves and use consultants to meet FDA requirements importing beverages from Vietnam.
Q: What happens if FDA refuses my beverage shipment from Vietnam? A refused shipment must be exported back to Vietnam or destroyed under FDA and CBP supervision. The importer bears all costs, including detention, demurrage, and re-export fees. This outcome is usually preventable with proper preparation for FDA requirements importing beverages from Vietnam.
Q: Do I need Prior Notice for beverage samples from Vietnam? Yes. Most commercial samples require Prior Notice before leaving Vietnam. Only very specific research shipments may qualify for exemption. Always file Prior Notice to comply with FDA requirements importing beverages from Vietnam.
Q: What is VQIP and how can it speed up my Vietnam beverage imports? The Voluntary Qualified Importer Program (VQIP) offers expedited FDA review for importers with strong compliance records. It requires an application and fee but can significantly reduce inspection rates and speed up port clearance for those meeting FDA requirements importing beverages from Vietnam.
Q: Does my Vietnamese beverage supplier need to comply with FSMA 204 traceability rules? The obligation mainly applies to foods on the FDA Food Traceability List. Most finished non-alcoholic beverages are not currently on the list, but certain ingredients may trigger requirements. The compliance deadline is July 20, 2028. Start assessing your products now under FDA requirements importing beverages from Vietnam.

Work with an FDA-Compliant Beverage Manufacturer in Vietnam

Work with an FDA-Compliant Beverage Manufacturer in Vietnam
Successfully meeting FDA requirements importing beverages from Vietnam requires close cooperation between the importer and the manufacturer. Interfresh is fully prepared on the manufacturing side — with active FDA registration, current certifications, validated processes, and ready-to-use documentation.
We help US distributors, wholesalers, and brand owners reduce compliance risk and accelerate their sourcing process.
Ready to start?
[Request a Free Quote] — [Download FDA Compliance Package] — [WhatsApp Our Export Team]

References

  1. US Food and Drug Administration (current, 21 CFR Part 1, Subpart H). Registration of Food Facilities https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions
  2. US Food and Drug Administration (current, 21 CFR Part 1, Subpart L). FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals
  3. US Food and Drug Administration (September 25, 2025). Final Rule: Information Required in Prior Notice of Imported Food — Amendments to 21 CFR Part 1, Subpart I. https://www.fda.gov/industry/fda-import-process/prior-notice-imported-foods
  4. US Food and Drug Administration (current, 21 CFR Parts 108, 113, 114). Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) and Acidified Foods. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-113
  5. US Food and Drug Administration (current, 21 CFR Part 101). Food Labeling. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101
  6. US Food and Drug Administration (March 2025, compliance date July 20, 2028). FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods — Section 204(d) of FSMA. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods
  7. US Food and Drug Administration (April 21, 2025). Import Alert 99-42: Detention Without Physical Examination of Foods Due to Heavy Metal (Toxic Element) Contamination — Revised. https://www.accessdata.fda.gov/cms_ia/importalert_1167.html
  8. US Food and Drug Administration (current). Import Alerts for Vietnam. https://www.accessdata.fda.gov/cms_ia/country_VN.html
  9. US Food and Drug Administration (current). Import Alert 99-32: Detention Without Physical Examination of Products from Foreign Establishments Refusing FDA Inspection https://www.accessdata.fda.gov/cms_ia/importalert_521.html
  10. US Food and Drug Administration (December 31, 2025). Voluntary Qualified Importer Program (VQIP) — FY2027 Application Portal Opens. https://www.fda.gov/food/importing-food-products-united-states/voluntary-qualified-importer-program-vqip
Legislative Foundation
  1. US Congress (2011). Food Safety Modernization Act (FSMA), Pub. L. 111-353, 124 Stat. 3885.

    https://www.congress.gov/111/plaws/publ353/PLAW-111publ353.pdf

  2. US Congress (2023). Food Allergy Safety, Treatment, Education, and Research (FASTER) Act — sesame allergen labeling effective January 1, 2023. https://www.congress.gov/bill/117th-congress/senate-bill/578
Industry and Compliance References
  1. S.J. Stile Associates (September 26, 2025). FDA Import Requirements in 2025: The Complete Guide for Food and Beverage Importers. https://stileintl.com/fda-import-requirements-food-beverage-importers/
  2. Registrar Corp (February 12, 2025). Import Alert 99-32: What Happens If I Refuse FDA Inspection? https://www.registrarcorp.com/blog/food-beverage/food-facility-registration/import-alert-99-32/
  3. Trace One (March 9, 2026). FSMA and US Food and Beverage Regulatory Compliance Guide: 2025–2028 Updates and Best Practices. https://www.traceone.com/fsma-us-food-and-bev-regulatory-compliance-guide
  4. Food Safety Magazine (August 6, 2025). After Extending Compliance Date, FDA Offers New FSMA 204 Resources for Industry. https://www.food-safety.com/articles/10591-after-extending-compliance-date-fda-offers-new-fsma-204-resources-for-industry
  5. ISO (2018). ISO 22000:2018 — Food Safety Management Systems: Requirements for Any Organization in the Food Chain. https://www.iso.org/standard/65464.html