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

FDA refusal charge UNAPPROVED: unapproved new drug

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The UNAPPROVED charge appeared in 2,406 FDA import refusals between 2020 and 2026 — 9.1% 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, Malaysia. The most-affected product category is Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. Volume in 2025 was up 54% on 2024.

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What FDA's charge says

UNAPPROVED 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) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Sections 505(a), 801(a)(3); UNAPPROVED NEW DRUG

UNAPPROVED refusals by year

YearRefusalsYoY
2020238—
2021390+63.9%
2022347-11.0%
2023283-18.4%
2024300+6.0%
2025461+53.7%
2026387—YTD
Total2,406

Origins most often refused under UNAPPROVED

#Origin countryRefusals
1India671
2Mexico516
3Malaysia193
4Turkey88
5United Kingdom85
6Guatemala81
7Canada76
8China63
9United States43
10Brazil34
11Colombia32
12Nigeria32
13Germany31
14Sri Lanka31
15El Salvador26
16South Korea24
17Spain23
18Indonesia20
19South Africa20
20Ghana17
21Thailand16
22Netherlands15
23Vietnam15
24Hong Kong14
25Italy13
26Honduras12
27Pakistan12
28Ecuador11
29Japan10
30Australia9

Product categories refused under UNAPPROVED

#Product categoryRefusals
1Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans2,046
2Dietary Conventional Foods and Meal Replacements184
3Soft Drinks and Waters36
4Food Sweeteners (Nutritive)19
5Spices, Flavors, and Salts18
6Candy Without Chocolate, Candy Specialties, and Chewing Gum12
7Coffee and Tea12
8Fruit and Fruit Products12
9Milk, Butter, and Dried Milk Products9
10Bakery Products, Doughs, Bakery Mixes, and Icings8
11Vegetable Oils (Includes Olive Oil)8
12Snack Food Items (Flour, Meal, or Vegetable Base)7
13Nuts and Edible Seeds5
14Whole Grains, Milled Grain Products, and Starch5
15Macaroni and Noodle Products4

Latest refusals citing UNAPPROVED

About UNAPPROVED

What does the FDA import refusal charge UNAPPROVED mean?

FDA uses UNAPPROVED for: unapproved new drug. Its published charge language reads: “The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).”

Is UNAPPROVED a food safety finding?

No. UNAPPROVED 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 UNAPPROVED?

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.