Last refresh: . 26,358 refusals since 2020-01-01.

FDA refusal charge FALSE: false or misleading label

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The FALSE charge appeared in 948 FDA import refusals between 2020 and 2026 — 3.6% of all 26,358 US import refusals. The charge is a labelling or registration failure, not a hazard found in the product. The origins cited most often are Mexico, India, Portugal. The most-affected product category is Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. Volume in 2025 was up 22% on 2024.

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What FDA's charge says

FALSE is the code FDA prints on a refusal; below is the charge language FDA publishes for it, quoted from its charge table, with the sections of the FD&C Act it cites.

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

Sections 403(a)(1), 801(a)(3); MISBRANDING

FALSE refusals by year

YearRefusalsYoY
2020124—
202187-29.8%
202262-28.7%
2023115+85.5%
2024178+54.8%
2025217+21.9%
2026165—YTD
Total948

Origins most often refused under FALSE

#Origin countryRefusals
1Mexico165
2India110
3Portugal110
4Philippines55
5Canada48
6China40
7Italy39
8South Korea38
9Germany33
10United Kingdom32
11Switzerland31
12Vietnam19
13United States18
14Guatemala15
15Indonesia15
16Australia12
17Bulgaria12
18Nigeria9
19Peru9
20Thailand9
21Turkey9
22Netherlands8
23New Zealand8
24Bangladesh7
25Malaysia7
26Japan5
27Jordan5
28Afghanistan4
29France4
30Pakistan4

Product categories refused under FALSE

#Product categoryRefusals
1Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans223
2Macaroni and Noodle Products113
3Baby (Infant and Junior) Food Products110
4Snack Food Items (Flour, Meal, or Vegetable Base)89
5Fruit and Fruit Products68
6Dietary Conventional Foods and Meal Replacements52
7Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet)50
8Fishery/Seafood Products41
9Soft Drinks and Waters34
10Bakery Products, Doughs, Bakery Mixes, and Icings33
11Vegetables and Vegetable Products19
12Milk, Butter, and Dried Milk Products18
13Candy Without Chocolate, Candy Specialties, and Chewing Gum16
14Spices, Flavors, and Salts10
15Whole Grains, Milled Grain Products, and Starch10

Latest refusals citing FALSE

About FALSE

What does the FDA import refusal charge FALSE mean?

FDA uses FALSE for: false or misleading label. Its published charge language reads: “The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.”

Is FALSE a food safety finding?

No. FALSE is a labelling or registration failure: the charge is about the label, the filing or the paperwork, not a hazard found in the product. A refusal citing it alone is counted as paperwork on this site.

What happens to a shipment refused under FALSE?

Under section 801(a) of the FD&C Act a refused entry has to be exported or destroyed, normally within 90 days of the notice of refusal. Bringing a product into compliance, for instance by relabelling, is something the importer asks FDA for before the decision is final. The notice itself and FDA's guidance govern a particular case; this page describes the published data and is not legal advice.