The short answer
FDA refuses food at the U.S. border for two broad reasons: the food is adulterated (unsafe, dirty, contaminated or made without required filings) or misbranded (the label breaks U.S. rules). Most refusals come from a short list of repeat problems — Salmonella, filth, pesticide residues, unapproved colors, missing canning filings, and label errors such as missing Nutrition Facts or undeclared allergens. Almost all of them can be prevented before the goods leave the factory.
What the data shows
USDA’s Economic Research Service has studied FDA’s refusal records. For 2005–2013, it found adulteration made up 57% of violations and misbranding 41%. Among pathogen and toxin violations, Salmonella was by far the largest: 79.8% over 2002–2019. FDA publishes current refusals every month in its Import Refusal Report, listed by country and product.
The most common refusal reasons
Each refusal is recorded with an FDA “charge”. These are the ones exporters meet most often, with the charge name FDA uses:
| Problem | FDA charge | How to prevent it |
|---|---|---|
| Salmonella | SALMONELLA | Validated kill step and lot testing for spices, herbs, sesame, nuts, seeds, dried coconut and pet food. |
| Filth or decomposition | FILTHY | Pest control, clean storage, sorting and inspection; especially for spices, dried fish, grains and dried fruit. |
| Insanitary conditions | INSANITARY | GMP and a working food safety plan at the facility; FDA may judge conditions from an inspection or import history. |
| Pesticide residues | PESTICIDES | Test against U.S. tolerances — not your home country’s limits. Tea, spices, rice and fresh produce are common problems. |
| Unapproved color additive | UNSAFE COL | Use only colors FDA lists for that food; check imported colorings and decorations. |
| No canning filings | NEEDS FCE / NO PROCESS | Register the canning facility (FCE) and file each scheduled process (SID) before shipping low-acid or acidified foods. |
| No Nutrition Facts | NUTRIT LBL | Use the U.S. Nutrition Facts format unless an exemption truly applies. |
| Ingredients not listed | LIST INGRE | Full ingredient list by common name, in descending order by weight. |
| Undeclared allergen | ALLERGEN | Declare all 9 major allergens, including sesame, in the ingredient list or a “Contains” statement. |
| Label not in English | NO ENGLISH | All required label information must be in English (other languages may be added). |
| Unregistered facility | FRNMFGREG | Keep the FDA food facility registration active and renewed in each even-numbered year. |
| Importer has no FSVP | FSVP VIO | Make sure your U.S. importer has an FSVP for your product and supplier. |
1. Contamination: Salmonella, filth and pesticides
These are adulteration charges, and they are the hardest to fix once the shipment has arrived — usually the lot is refused. They are also the charges most likely to put your company on an import alert, after which every future shipment is held until proven clean.
Prevention is about the process, not paperwork: a validated treatment for dry foods that can carry Salmonella (steam, irradiation or another validated step), good storage and pest control, and residue testing against U.S. tolerances. A product that meets the limits in India, Vietnam or Mexico can still exceed a U.S. tolerance — or have no U.S. tolerance at all for that pesticide.
2. Label problems (misbranding)
Label refusals are the most avoidable. Common errors include:
- No U.S.-format Nutrition Facts panel, or a panel copied from an EU or Asian label
- Major allergens not declared, or declared in the wrong way
- Missing or incomplete ingredient list
- Required information not in English
- Net quantity not shown in both U.S. and metric units
- Claims (“healthy”, “cures”, “boosts immunity”) that make the food look like a drug
Labels can sometimes be fixed after detention by relabeling under FDA supervision — but that costs time and money. It is cheaper to get the label right before printing. See our FDA food label checklist.
3. Missing registrations and filings
- Food facility registration: the foreign facility that makes, processes or packs the food must be registered with FDA, with a U.S. Agent, and renewed between October 1 and December 31 of each even-numbered year.
- Canned and acidified foods: the facility needs an FCE number and each product an SID (scheduled process) filing. Fruit pulp, pickles, canned vegetables and coconut milk are frequent problems. See FCE and SID registration.
- Prior Notice: food shipments need Prior Notice before they arrive. Without valid Prior Notice, food is held at the port.
- FSVP: if the U.S. importer has no FSVP, shipments can be held under Import Alert 99-41.
Pre-shipment checklist
- 1Registration currentFDA food facility registration active, with a U.S. Agent, and FCE/SID filed if needed.
- 2Label reviewedNutrition Facts, ingredients, 9 allergens, English, net quantity and claims.
- 3Lot testedFor your product’s known risks: Salmonella, pesticides, heavy metals, aflatoxin or histamine.
- 4Importer readyU.S. importer has an FSVP; Prior Notice filed with the correct registration number.
- 5Check import alertsMake sure your product, your company and your suppliers are not on an FDA import alert.
FDA label review from $250. Registration with U.S. Agent from $300. FCE $550, SID $350.
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP agent service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
Frequently asked questions
What is the most common reason FDA refuses food?
Over the long term, adulteration charges — including Salmonella, filth and pesticide residues — are more common than label charges. USDA’s analysis of 2005–2013 refusals found adulteration in 57% of violations and misbranding in 41%. Label errors are still very common, especially for snacks, sweets and bakery products.
Where can I see which products FDA refused?
FDA’s Import Refusal Report lists refusals by country and product type and is updated monthly. It shows the charges for each refused line.
Can a refused shipment be fixed and released?
Before refusal, a detained shipment can sometimes be reconditioned or relabeled with FDA permission. Once refused, it must be exported or destroyed within 90 days. See what to do if your shipment is detained.
Does a refusal affect future shipments?
Yes. FDA screens imports using past history. Refusals increase the chance of examination and, if repeated, can lead to an import alert.
Sources
- FDA — Import Refusals (Import Refusal Report)
- USDA ERS — Patterns in FDA food import refusals (2016; data 1998–2013)
- USDA ERS — Examining pathogen-based import refusals, 2002–2019 (December 2021)
- FDA — FASTER Act: Sesame is the ninth major food allergen
Figures and FDA procedures checked against FDA and USDA sources on November 11, 2026. This article is general information, not legal advice.