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

FDA refusal charge NOT LISTED: establishment not listed

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The NOT LISTED charge appeared in 204 FDA import refusals between 2020 and 2026 — 0.8% of all 26,358 US import refusals. The charge is a process, registration or approval failure, not a contaminant or pathogen found in the product. The origins cited most often are India, Mexico, China. The most-affected product category is Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. Volume in 2025 was up 50% on 2024.

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What FDA's charge says

NOT LISTED 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.

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Sections 502(o), 801(a)(3); MISBRANDING

NOT LISTED refusals by year

YearRefusalsYoY
20209—
202112+33.3%
202211-8.3%
202333+200.0%
202432-3.0%
202548+50.0%
202659—YTD
Total204

Origins most often refused under NOT LISTED

#Origin countryRefusals
1India65
2Mexico21
3China12
4Canada11
5Guatemala9
6Germany7
7Colombia6
8France5
9United Kingdom5
10Brazil4
11El Salvador4
12Nigeria4
13United Arab Emirates4
14Vietnam4
15Dominican Republic3
16Indonesia3
17Ivory Coast3
18South Africa3
19Turkey3
20United States3
21Honduras2
22Italy2
23Netherlands2
24Philippines2
25Russia2
26South Korea2
27Spain2
28Australia1
29Austria1
30Chile1

Product categories refused under NOT LISTED

#Product categoryRefusals
1Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans185
2Dietary Conventional Foods and Meal Replacements10
3Food Sweeteners (Nutritive)3
4Candy Without Chocolate, Candy Specialties, and Chewing Gum1
5Milk, Butter, and Dried Milk Products1
6Nuts and Edible Seeds1
7Snack Food Items (Flour, Meal, or Vegetable Base)1
8Spices, Flavors, and Salts1
9Whole Grains, Milled Grain Products, and Starch1

Latest refusals citing NOT LISTED

About NOT LISTED

What does the FDA import refusal charge NOT LISTED mean?

FDA uses NOT LISTED for: establishment not listed. Its published charge language reads: “It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).”

Is NOT LISTED a food safety finding?

No. NOT LISTED is a process, registration or approval failure: the charge records a missing filing, registration, approval or process control, not a contaminant or pathogen found in the product. This site counts a refusal citing it alone with paperwork. It can still mean the product cannot lawfully be sold in the US.

What happens to a shipment refused under NOT LISTED?

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.