Food &
Beverages
The most common FDA pathway for international exporters. Covers facility registration, the FEI number, biennial renewal, FSMA compliance, Prior Notice filing, FSVP obligations, ingredient safety (GRAS), and complete food labeling requirements — with everything a consultant needs to get a food client fully compliant before their first U.S. shipment.
What "Food" Means Under FDA Law
Under 21 U.S.C. § 321(f), "food" means articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article. This is a remarkably broad definition — it includes raw agricultural commodities, processed foods, beverages, bottled water, chewing gum, ingredients, food additives, dietary supplements (which are a subcategory of food), and even food packaging materials that migrate into food.
What food does NOT include under FDA's jurisdiction: meat, poultry, and egg products (regulated by USDA/FSIS), alcoholic beverages (TTB for the alcohol itself; FDA for food additives and labeling), and drinking water from public systems (EPA). Everything else that you consume, ingest, or add to something you consume is food under FDA's authority — and most of it requires facility registration before it can enter the United States.
Register First. Ship Second. Never the Other Way Around.
Many international food companies begin exporting to the U.S. informally — a distributor places an order, the factory ships, nobody mentions FDA. This is a legal violation from the first shipment. Unregistered facilities shipping food to the U.S. are shipping adulterated food under 21 U.S.C. § 342(j) — a fact that shocks most clients when they first hear it. Your job is to catch this before CBP does.
Who Must Register — And Who Is Exempt
The Bioterrorism Act (2002) and FSMA (2011) together created the food facility registration requirement. Any facility that manufactures, processes, packs, or holds food for consumption in the United States must register — whether located domestically or overseas.
- Foreign manufacturers exporting any food or beverage to U.S. consumers
- Domestic food manufacturers, processors, and co-packers
- Cold storage warehouses and third-party logistics facilities holding food
- Importers who own or control the food during U.S. storage
- Contract manufacturers making food products for other brands
- Facilities that re-pack or re-label food products
- Slaughterhouses for non-USDA species (e.g., rabbit, bison)
- Seafood processing facilities (including aquaculture)
- Farms — including farm-direct sales with very limited exceptions
- Restaurants and retail food establishments selling directly to consumers
- Fishing vessels (not engaged in processing)
- Nonprofit food establishments
- Private residences (even if selling food from home)
- Facilities regulated exclusively by USDA/FSIS (meat, poultry, egg processing)
- Facilities making food only for personal or family consumption
- Certain small facilities qualifying for FSMA qualified exemptions
The "Farm" Exemption Trap: The farm exemption is narrower than most clients assume. A farm that grows produce and sells it at a farmers market is exempt. That same farm, if it starts washing, cutting, packaging, and refrigerating its produce for wholesale distribution — has now added "processing" activities that may trigger registration requirements. The line between farm and food facility is one of the most frequently litigated classification questions in food regulation.
Food Facility Registration — Step by Step
Food facility registration is free, electronic, and for most facilities, immediate upon submission. It is done through FDA's Unified Registration and Listing System (FURLS) at access.fda.gov. Here is the exact process:
• Facility legal name and trade name (if different)
• Complete physical address (no P.O. boxes)
• Facility phone number and email
• Owner/operator/agent name and contact information
• Emergency contact (24/7 reachable person)
• U.S. Agent name, address, phone, email (foreign facilities only)
• Type of activity: manufacturer, packer, warehouse, etc.
• FDA product type codes for all foods handled (see CFSAN product code list)
• Whether the facility is subject to the Preventive Controls rule
Renewal Calendar — Never Miss the Window
The biennial renewal window is one of the most commonly missed compliance deadlines. Put this in your calendar for every food client.
Registration Suspension Authority: Under FSMA, FDA can suspend a facility's registration if it determines there is a reasonable probability that food from that facility will cause serious adverse health consequences or death. Suspension is immediate and doesn't require a court order — FDA can act administratively. Suspension means the facility cannot export to the U.S. until the suspension is lifted. This is a dramatic enforcement tool used rarely but powerfully.
Prior Notice — The Pre-Import Filing Requirement
Prior Notice (PN) is required for every food shipment imported into the United States. It must be submitted electronically before the shipment arrives at the U.S. port of entry. There are no exceptions, no grace periods, and no after-the-fact remedies. This is one of the most operationally critical compliance requirements for food exporters.
Timing Requirements by Transport Mode
What Prior Notice Must Include
Prior Notice is filed through FDA's Prior Notice System Interface (PNSI) at access.fda.gov or via CBP's Automated Broker Interface (ABI) used by licensed customs brokers. Every submission must include:
| Required Field | Detail | Common Error |
|---|---|---|
| Article Information | FDA product code, product description, country of origin, quantity (units and weight), lot or code number | Wrong FDA product code — causes mismatch with facility registration |
| Manufacturer FEI | Food Establishment Identifier of the manufacturer | Using an old or expired FEI; forgetting to include the FEI entirely |
| Shipper FEI | FEI of the facility that shipped the product (may differ from manufacturer) | Not including shipper if different from manufacturer |
| Grower Information | For produce: name and country of the farm or growing facility | Often omitted for produce shipments |
| Carrier Information | Name of carrier, voyage/flight/vehicle number, mode of transportation | Outdated carrier info if shipment routing changes |
| Arrival Information | Anticipated arrival date, port of entry, entry type | Wrong port of entry when routing changes mid-transit |
| Submitter Information | Name and contact info of person submitting (importer, broker, or agent) | Using outdated contact information |
What Happens After Prior Notice Is Submitted
Upon submission, FDA generates a Prior Notice Confirmation Number. This number must be given to the customs broker before the shipment arrives — CBP requires it as part of the import entry process. FDA reviews the Prior Notice using its PREDICT risk screening system and may:
- Release the shipment — No action required. The vast majority of Prior Notices result in release.
- Request hold for examination — FDA field staff will physically examine, document, or sample the shipment.
- Issue a Notice of Detention — If Prior Notice contains incorrect or incomplete information, or the shipment appears to have a compliance issue.
- Issue a Refusal — For prior notice that was not submitted at all, or is submitted for a product from a facility on an import alert.
If Prior Notice Was Not Filed: FDA will refuse the shipment at the port of entry. The importer cannot re-file after the fact. The shipment must either be re-exported out of the United States (at full cost to the importer) or destroyed under CBP supervision. Storage accrues at commercial rates during this period. A single missed Prior Notice on a $200,000 seafood container can result in total product loss.
FSMA Compliance — Beyond Registration
Registration gets you in the door. FSMA compliance keeps you there. Since 2016, FDA has been enforcing the FSMA rules that require food facilities to actively prevent contamination — not just respond to it after the fact. For international exporters, the most practically significant FSMA rules are:
Requires covered facilities to have a written Food Safety Plan that includes: (1) a hazard analysis identifying all significant biological, chemical, physical, and radiological hazards; (2) preventive controls to address each significant hazard; (3) monitoring procedures; (4) corrective action procedures; (5) verification activities; and (6) a recall plan. The plan must be prepared or overseen by a Preventive Controls Qualified Individual (PCQI) — someone who has successfully completed PCQI training (typically a 2-day course recognized by FDA).
Who is covered: All facilities that manufacture, process, pack, or hold food — with some size-based exemptions for very small businesses. Foreign facilities exporting to the U.S. are covered if they send food into interstate commerce in the U.S.
What exemptions exist: Facilities averaging less than $1M in annual food sales over the previous 3 years that sell primarily directly to consumers or to restaurants/retailers in the same state or within 275 miles may qualify as "qualified facilities" with reduced requirements.
- Hazard analysis must consider: biological hazards (Salmonella, E. coli, Listeria), chemical hazards (allergens, pesticides, mycotoxins), physical hazards (glass, metal, bone), and radiological hazards
- Preventive controls include: process controls (e.g., cooking temperatures), food allergen controls, sanitation controls, supply-chain controls, and recall plans
- Records must be kept for 2 years minimum and be available for FDA inspection within 24 hours upon request
FSVP places the compliance verification burden on U.S. importers — not on foreign facilities. Every U.S. importer of food must develop, maintain, and follow a written FSVP for each food imported and each foreign supplier. This is a critical consulting service opportunity: U.S. importers often don't know they need FSVP documentation, and foreign suppliers often need to produce records to support their U.S. buyer's FSVP obligations.
FSVP core requirements for U.S. importers:
- Hazard analysis: Identify hazards reasonably likely to occur with the food being imported
- Supplier evaluation: Evaluate the supplier's performance and the risk of the food. Methods include: review of FDA inspection reports, third-party audit results, supplier testing records, or visiting the facility
- Verification activities: Onsite auditing, product sampling/testing, review of the supplier's food safety records, or some combination
- Corrective actions: What the importer does if a verification activity reveals a problem
- Reassessment: The FSVP must be reviewed and updated at least every 3 years or when new information is received
- FSVP records: Must be retained for 2 years; must be available for FDA inspection within 24 hours
What foreign suppliers must provide to support their buyer's FSVP: Food safety plan summaries, audit reports, testing records, regulatory inspection history, and documentation of PCQI training if applicable. Being FSVP-ready — having documentation organized and accessible — significantly accelerates import clearance for repeat shipments.
Applies to farms that grow, harvest, pack, or hold covered produce (most fruits and vegetables eaten raw). Establishes science-based standards for:
- Agricultural water: Water used to irrigate or apply to produce must meet specific microbial quality standards. Requires testing and corrective actions if standards aren't met.
- Biological soil amendments: Treated and untreated manure, compost, and other biological amendments — minimum application intervals, treatment requirements
- Worker health and hygiene: Sick worker policies, hand washing facilities, training requirements
- Domesticated and wild animals: Monitoring for animal intrusion; response protocols if animals access growing areas
- Equipment, tools, buildings: Sanitation, maintenance, and design requirements for all surfaces that contact produce
- Sprouts: Additional requirements for sprouts, which carry elevated microbial risk
Covered produce vs. exempt produce: Raw agricultural commodities rarely consumed raw (e.g., potatoes, winter squash) are not covered. Produce consumed only after commercial processing that kills pathogens is not covered. Produce grown for personal or on-farm consumption is not covered.
Applies to shippers, loaders, carriers, and receivers engaged in transporting human and animal food by motor vehicle or rail. Key requirements:
- Vehicle and equipment: Must be designed, maintained, and cleaned to prevent food from becoming adulterated during transport
- Temperature control: Vehicles must maintain adequate temperature control for foods requiring refrigeration
- Cleaning and sanitizing: Vehicles must be cleaned before loading; prior cargo must not contaminate food
- Previous cargo: Shippers must inform carriers about any non-food cargo requirements that could contaminate food
- Written procedures: Carriers must have written procedures for temperature monitoring, vehicle cleaning, and pest control
Ingredient Safety — GRAS and Food Additives
One of the most frequently overlooked compliance issues for international food exporters is ingredient safety under U.S. law. An ingredient that is widely used and legally permitted in one country may be prohibited or restricted in the United States. Before completing any registration for a food client, verify the GRAS status of every ingredient.
What Is GRAS?
Under 21 U.S.C. § 321(s), a substance is exempt from the food additive pre-approval requirement if it is "generally recognized as safe" (GRAS) by qualified experts based on either scientific procedures or a history of safe use before 1958. GRAS status can be established in two ways:
Common International Ingredient Issues
| Ingredient / Additive | Status in Many Countries | U.S. Status | Action Required |
|---|---|---|---|
| Bromated vegetable oil (BVO) | Used as emulsifier in citrus drinks | FDA revoked GRAS in 2024 — now prohibited | Reformulate before exporting to U.S. |
| Potassium bromate | Common bread improver in many countries | Not permitted in U.S. (banned in most states) | Reformulate — cannot use in U.S.-destined bread |
| Azo dyes (certain food colors) | Widely permitted in Asia, Middle East | Many not approved as U.S. food color additives | Check 21 CFR Part 74 for approved colors; reformulate if using unapproved dyes |
| Stevia (high-purity extracts) | Approved food additive in many countries | GRAS (GRAS Notice GRN 252 and others) | Must use at levels consistent with GRAS notification |
| Carrageenan | Widely used thickener globally | GRAS with ongoing safety discussions; still permitted in most applications | Monitor FDA's position; document usage level |
| Novel herbs and botanicals | Traditional use in home country | May have no GRAS status in U.S. | Research GRAS database; may need to file GRAS notification before marketing |
| Cyclamates | Permitted sweetener in 100+ countries | Banned in U.S. since 1969 (FDA has not approved a food additive petition) | Cannot be used in U.S. food products under any circumstances |
How to Check GRAS Status: Search FDA's GRAS Notice Inventory at accessdata.fda.gov/scripts/fdcc/?set=GRASNotices. Check the affirmed GRAS list at 21 CFR Parts 182–186. For approved food additives: 21 CFR Parts 172–180. When in doubt, contact CFSAN's Office of Food Additive Safety — informal inquiries are accepted and can save clients from reformulating after import refusal.
Food Labeling — The Complete Requirements
Labeling violations are the #1 cause of food import detentions. A product can be safely manufactured, properly registered, and correctly Prior Noticed — and still be detained because the label says "Net Wt. 500g" without a U.S. unit equivalent. FDA inspectors are trained to identify specific labeling deficiencies quickly. Know these requirements cold.
The Nine Major Allergens — Memorize These
Under FALCPA (2004) and the FASTER Act (2021), nine foods must be declared as major food allergens on all food labels. Undeclared allergens are the most common cause of Class I food recalls in the United States — recalls with the highest urgency level because of the immediate risk to consumer health.
Sesame is still being missed. Sesame became the 9th major allergen effective January 1, 2023. Many international food companies exporting to the U.S. still have not updated their labels to declare sesame. Products containing tahini, sesame oil, sesame seeds, or sesame flour in any quantity must declare sesame as an allergen — using either the ingredient list (e.g., "sesame seeds") or a "Contains: Sesame" statement. Check every client's label for this specifically.
Nutrition Facts Panel — The 2020 Update
The Nutrition Facts panel underwent its most significant update since 1994, effective for most manufacturers in 2020–2021. Many international exporters are still using the old format — a labeling deficiency that will cause import examination delays and potentially refusal.
• "Calories from Fat" line present
• Serving sizes not updated for modern consumption patterns
• No "Added Sugars" line
• Vitamin A and C listed; Vitamin D and Potassium not required
• "% Daily Value" based on older RDAs
• "Calories from Fat" line removed
• Serving sizes updated to reflect actual amounts consumed
• "Added Sugars" — separate line under Total Sugars
• Vitamin D and Potassium required; Vitamin A and C optional
• Dual-column format for packages containing 2–3 servings
Serving Size — The Most Commonly Wrong Element
Serving sizes must now reflect the amount typically consumed at one sitting — not the manufacturer's preferred serving. FDA updated the Reference Amounts Customarily Consumed (RACC) for dozens of food categories. Examples of changes:
| Food Category | Old RACC | New RACC (2020) |
|---|---|---|
| Ice cream / frozen desserts | ½ cup (about 65g) | ⅔ cup (about 85g) |
| Carbonated beverages | 8 fl oz (240mL) | 12 fl oz (360mL) |
| Muffins, sweet rolls | 55g | 1 unit (often 130g+) |
| Bagels | 55g (½ bagel) | 1 medium (110g) |
| Coffee (ready-to-drink) | 8 fl oz | 12 fl oz |
| Chips, pretzels, popcorn | 30g | 30g (unchanged for most) |
The Most Common Food Labeling Violations at the U.S. Border
Based on FDA's public import refusal data and warning letter database, these are the labeling violations most likely to cause a client's shipment to be detained or refused:
The Complete Food Client Engagement Workflow
Here is the exact sequence for onboarding a new food exporter client from zero to first legal U.S. shipment:
First Shipment to the U.S. — Everything That Can Go Wrong
A Sri Lankan seafood processor has been exporting to Europe and the Middle East for 10 years. A U.S. seafood distributor places their first order — $140,000 of frozen shrimp. The exporter assumes their existing certifications (EU, HACCP) are sufficient for the U.S. They ship without consulting anyone. Here is what happens at the Port of Los Angeles:
- No FDA registration: The facility has no FEI number. The shipment is flagged immediately — the product is legally adulterated under 21 U.S.C. § 342(j).
- No Prior Notice: The customs broker didn't know Prior Notice was required. CBP has no PN confirmation number. FDA issues an automatic refusal.
- Label issues: Net weight shown in grams only (no U.S. ounce equivalent). No U.S. allergen declaration for shellfish (which must specify "shrimp"). Label entirely in Sinhala with no English text.
- Ingredient issue: One product line contains a food color approved in Sri Lanka and the EU but not approved in the U.S. Product is adulterated by the presence of an unapproved color additive.
The shipment is refused. The U.S. distributor must arrange re-export of a $140,000 container at their own cost. The Sri Lankan exporter loses the client relationship and faces a $180,000 total loss (product value + shipping cost) because no one engaged a regulatory consultant before the first shipment.
- Food facility registration is free, electronic, and mandatory for any facility exporting food to the U.S. The FEI number is permanent, required for every Prior Notice, and must be renewed biennially (Oct–Dec of even years). Missing renewal = registration cancelled = product legally adulterated.
- Prior Notice must be filed for every food shipment — 2 hours before arrival for trucks, 4 for air and rail, 8 for ocean. No Prior Notice = automatic refusal at the border. There is no after-the-fact remedy. The confirmation number must reach the customs broker before the shipment arrives.
- FSMA shifted food safety from reactive to preventive. Covered facilities must have a written Food Safety Plan prepared by a PCQI. U.S. importers must have FSVP documentation — foreign suppliers must produce records to support their buyers' FSVP obligations. This is a major, recurring consulting service opportunity.
- Ingredient safety under U.S. law is separate from safety in the exporter's home country. GRAS status is required for all food ingredients. Common violations: unapproved color additives (azo dyes), bromated vegetable oil (now banned), cyclamates (banned since 1969). Check every client's ingredient list against FDA's GRAS database and approved additives list.
- The nine major allergens (milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, soybeans, sesame) must be declared on every food label. Sesame was added effective January 1, 2023, and is still frequently missing from international food labels. Undeclared allergens trigger Class I recalls — the most serious recall category.
- The 2020 Nutrition Facts panel update is mandatory and still not implemented on many international food labels. Key changes: larger calorie display, added sugars line, removed "calories from fat," updated serving sizes. Old-format labels are misbranded.
- The complete food client workflow — intake, label review, ingredient audit, registration, FSMA assessment, Prior Notice setup, compliance package — is a structured, repeatable service that can be packaged and priced as a fixed-fee "U.S. Market Entry" engagement.
Ready to register your food facility with FDA?
Regovant handles food facility registration, US Agent services, label review, FSMA compliance assessment, and Prior Notice setup — the complete U.S. market entry package for food exporters in 60+ countries.