Two in five US "paperwork" food refusals are dietary supplements

Since 2020, FDA has refused 7,099 food shipments at the US border without citing any safety hazard. 2,982 of them (42%) were dietary supplements. For all other food, fewer than one refusal in five is paperwork.

When FDA refuses a food shipment, one of two things usually went wrong. Either something unsafe was found (filth, Salmonella, pesticide residues, an unapproved colour) or the paperwork failed: a missing nutrition panel, no English label, a facility that never registered. Across all food, 27% of US refusals since January 2020 are paperwork.

That average hides one category.

Supplements are 15% of refusals but 42% of the paperwork. Most supplement refusals are not about what is in the capsule. They are about what the label claims. The leading charge, on 1,922 supplement refusals, is unapproved new drug: the product is marketed with claims that, under US law, make it a drug that nobody approved. Next come nutrition and supplement-facts labelling, missing English text and missing contact details.

Why this changes country rankings

Because the paperwork is concentrated in one product, it also concentrates in the countries that ship that product. Rankings that mix hazard and paperwork penalise supplement exporters for what are mostly labelling decisions:

On a combined table, the UK sits 12th among origins. Count only hazard refusals and it falls to 18th. Malaysia falls out of the top 25 altogether. At the other end, Vietnam, Pakistan and Bangladesh are refused almost entirely for what was found in the product.

Not every supplement refusal is paperwork: kratom

Indonesia is fourth among origins with 1,097 refusals, and it ships a lot of supplements. Yet only 10% of its refusals are paperwork. The reason is kratom. FDA refuses kratom as an unsafe dietary ingredient: the charge is that the product "presents a significant or unreasonable risk of illness or injury". That is a safety finding, not a labelling one. Since 2020 kratom accounts for 322 US refusals, and 267 of them came from Indonesia.

So "it's a supplement, so it's probably paperwork" is a useful rule of thumb that fails for exactly the product with the most safety concern. Check the charge, not the category. Indonesia's supplement page lists each refusal with its charges.

What this means if you…

• …import or export supplements into the US: for most products your risk is regulatory, not microbiological. A review of claims and labels before shipping addresses most refusals in this category. A lab test addresses few of them. The exception is a botanical FDA considers unsafe, where no label will help.
• …compare suppliers or origins: use the hazard count, not the total. The hazard pages split every figure. Labelling and Process and registration are the two paperwork groups.
• …write about US food safety: a headline refusal count for a country that ships supplements is often a labelling story. Check the split before calling it a safety problem.

Other categories where refusals are mostly paperwork

Outside supplements, a few categories are also mostly paperwork: baby and infant food (91%), meal replacements (78%) and coffee and tea (67%). Nuts (7%), seafood (9%) and fruit (12%) are the opposite: when they are refused, it is almost always for something found in the product.

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Method. 25,892 FDA import refusals dated 1 January 2020 to 10 September 2026 from FDA's Data Dashboard. A refusal counts as a hazard if any of its charges falls in a hazard group (filth, pathogens, residues, contaminants, unsafe additives and unsafe dietary ingredients, allergens and similar); otherwise it counts as paperwork. A refusal carrying both counts once, as a hazard. Supplements are FDA product category 54, "Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans". Unapproved new drug counts as paperwork because the charge concerns how a product is marketed, not something found in it; counting it as a hazard instead lowers the overall paperwork share to 21%. Rankings are by origin country; a refusal naming two origins counts for both.