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

FDA refusal charge HEALTH C: unauthorized health claim

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The HEALTH C charge appeared in 188 FDA import refusals between 2020 and 2026 — 0.7% 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 India, Canada, Nigeria. The most-affected product category is Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. Volume in 2025 was down 13% on 2024.

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What FDA's charge says

HEALTH C 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 misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.

Sections 801(a)(3); 403(r)(1)(A)/(B) misbranding

HEALTH C refusals by year

YearRefusalsYoY
202032—
202117-46.9%
202213-23.5%
202330+130.8%
202438+26.7%
202533-13.2%
202625—YTD
Total188

Origins most often refused under HEALTH C

#Origin countryRefusals
1India32
2Canada14
3Nigeria14
4Mexico10
5United States8
6China7
7Pakistan7
8South Korea7
9United Kingdom7
10Taiwan6
11Brazil4
12Colombia4
13Germany4
14Australia3
15Dominican Republic3
16Indonesia3
17Italy3
18Kenya3
19Philippines3
20Portugal3
21Thailand3
22Ecuador2
23Ghana2
24Guatemala2
25Israel2
26Jamaica2
27Netherlands2
28Russia2
29Serbia2
30Vietnam2

Product categories refused under HEALTH C

#Product categoryRefusals
1Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans87
2Dietary Conventional Foods and Meal Replacements13
3Macaroni and Noodle Products11
4Coffee and Tea9
5Candy Without Chocolate, Candy Specialties, and Chewing Gum7
6Milk, Butter, and Dried Milk Products6
7Baby (Infant and Junior) Food Products5
8Bakery Products, Doughs, Bakery Mixes, and Icings5
9Spices, Flavors, and Salts5
10Vegetables and Vegetable Products5
11Chocolate and Cocoa Products4
12Fruit and Fruit Products4
13Snack Food Items (Flour, Meal, or Vegetable Base)4
14Soft Drinks and Waters4
15Cereal Preparations, Breakfast Foods3

Latest refusals citing HEALTH C

About HEALTH C

What does the FDA import refusal charge HEALTH C mean?

FDA uses HEALTH C for: unauthorized health claim. 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 misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.”

Is HEALTH C a food safety finding?

No. HEALTH C 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 HEALTH C?

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.