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FDA refusal charge

FDA refusal charge HEALTH C

Unauthorized nutrient content or health claim

HEALTH C is the FDA import refusal charge for unauthorized nutrient content or health claim; it cites section 801(a)(3) of the FD&C Act (403(r)(1)(a)/(b) misbranding). FDA recorded it on 759 refused shipment lines between October 2016 and September 1, 2026, most often for dietary supplements from Australia.

Data from FDA public records, last checked .

759
refused shipment lines carry this charge
67
countries of origin
1
import alert names this charge

What HEALTH C means

The label or labeling appeared to carry a nutrient content claim or health claim that is not authorized.

This restates FDA's statement. It says what the charge means, never why a particular shipment was refused.

FD&C Act section
801(a)(3)
Classification
403(r)(1)(a)/(b) misbranding

FDA's official statement

Copied unchanged from FDA's Refusal Charges reference table.
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.
HEALTH C · 801(a)(3); 403(r)(1)(A)/(B) misbrandingFDA reference table (CSV)

Import alerts that name HEALTH C

The charge section of each alert names this code. An alert lists firms; a charge is the reason recorded on one refused line.
Import alerts naming HEALTH C as a charge
AlertCoversRedGreen
99-39Imported foods that appear to be misbranded677

Countries with the most HEALTH C refusals

Shipment lines carrying HEALTH C, by country of origin.
HEALTH C refusal lines by country
CountryLinesShare of HEALTH C
Australia8812%
India8812%
Canada588%
Mexico588%
United Kingdom476%
Nigeria365%
Ghana314%
Malaysia274%
Germany213%
China203%

Product categories with the most HEALTH C refusals

HEALTH C refusal lines by product category
CategoryLinesShare of HEALTH C
Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties43657%
Coffee and Tea385%
Dietary Conventional Foods and Meal Replacements344%
Macaroni and Noodle Products233%
Fruit and Fruit Products (pit, subtropical and tropical fruits)233%
Candy without Chocolate, Candy Specialties, and Chewing Gum203%
Spices, Flavors, and Salts182%
Cereal Preparations, Breakfast Foods172%
Bakery Products, Doughs, Bakery Mixes, and Icings142%
Baby (Infant and Junior) Food Products132%

Latest HEALTH C refusals

The 20 most recent refused lines, through September 1, 2026, each with its FDA source.
Latest FDA refusals carrying HEALTH C
DateFirmProductCharges
Khyati Global Ventures LimitedMumbai, IndiaMustard oil, refined, single ingredient, see 28o for mustard oil as a flavoringUNSAFE ADDHEALTH CSource
Hemani InternationalKarachi, PakistanHerbals & botanicals (not teas), n.e.cDIETARYLBLLACKS FIRMNUTRIT LBL+1Source
Indus Life Sciences Pvt LtdChennai, IndiaVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cDIETARYLBLLABELINGNUTRIT LBL+1Source
Pepsico India Holding Pvt LtdPune, IndiaPotato chips,friedLIST INGRECOLOR LBLGLACKS FIRM+5Source
Nestle India LtdNangal Kalan, IndiaNoodles and noodle products, n.e.cLIST INGRECOLOR LBLGLACKS FIRM+4Source
Ushas Nigerian ServicesLacros, NigeriaNonalcoholic beverages, n.e.cHEALTH CSource
AVA Plant Co.,LtdBangkok, ThailandHerbals & botanicals (not teas), n.e.cHEALTH CSource
AVA Plant Co.,LtdBangkok, ThailandAshwagandha (herbal & botanicals, not teas)HEALTH CSource
AVA Plant Co.,LtdBangkok, ThailandHerbals & botanicals (not teas), n.e.cHEALTH CSource
Lambac S.A.Guayas, EcuadorHerbals & botanicals (not teas), n.e.cLABELINGNUTRIT LBLHEALTH CSource
Lambac S.A.Guayas, EcuadorHerbals & botanicals (not teas), n.e.cHEALTH CSource
Nativo Trade S.R.L.Manoguayabo, Dominican RepublicVitamin aNOT LISTEDHEALTH CSource
Med Plants of Mexico AkDelegacion, MexicoFoods with supplemental nutrients added, with or without artifical sweetnersNO ENGLISHDIETARYINGLABELING+1Source
William XylitolUlsan, South KoreaMineral n.e.cLIST INGRENUTRIT LBLHEALTH C+1Source
Infrasource ResourcesIsawo, NigeriaFlours and meals n.e.cLIST INGRELACKS N/CNUTRIT LBL+1Source
Chanrai Brands LimitedTema, GhanaOleomargarine, n.e.cLACKS N/CALLERGENNUTRIT LBL+1Source
Sina Company IndonesiaDenpasar, IndonesiaHoneyFALSEHEALTH CSource
Nestle NigeriaIlupeju, NigeriaMixed cereal, quick or instant cookingLIST INGREFALSELACKS N/C+2Source
RDE Manufacturing Inc.Sarnia, CanadaVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cDIETARYLBLNCONTACTNUTRIT LBL+1Source
RDE Manufacturing Inc.Sarnia, CanadaVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cDIETARYLBLNCONTACTNUTRIT LBL+1Source

Questions about HEALTH C

What does HEALTH C mean on an FDA refusal?
HEALTH C is the refusal charge “Unauthorized nutrient content or health claim”. The label or labeling appeared to carry a nutrient content claim or health claim that is not authorized.
What law does HEALTH C cite?
FDA's refusal charge table cites section 801(a)(3) of the FD&C Act (403(r)(1)(a)/(b) misbranding) for HEALTH C, and classifies the charge as 403(r)(1)(a)/(b) misbranding. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
Which countries have the most HEALTH C refusals?
As of October 25, 2026, the countries with the most HEALTH C refusal lines are Australia (88), India (88) and Canada (58). The full list with links is in the table on this page.
Is there an FDA import alert for HEALTH C?
Yes. One FDA import alert names HEALTH C as a charge code, including Import Alert 99-39 (Imported foods that appear to be misbranded). An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.