FDA refusal charge
FDA refusal charge HEALTH C
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
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.
Import alerts that name HEALTH C
| Alert | Covers | Red | Green |
|---|---|---|---|
| 99-39 | Imported foods that appear to be misbranded | 677 |
Countries with the most HEALTH C refusals
Product categories with the most HEALTH C refusals
| Category | Lines | Share of HEALTH C |
|---|---|---|
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 436 | 57% |
| Coffee and Tea | 38 | 5% |
| Dietary Conventional Foods and Meal Replacements | 34 | 4% |
| Macaroni and Noodle Products | 23 | 3% |
| Fruit and Fruit Products (pit, subtropical and tropical fruits) | 23 | 3% |
| Candy without Chocolate, Candy Specialties, and Chewing Gum | 20 | 3% |
| Spices, Flavors, and Salts | 18 | 2% |
| Cereal Preparations, Breakfast Foods | 17 | 2% |
| Bakery Products, Doughs, Bakery Mixes, and Icings | 14 | 2% |
| Baby (Infant and Junior) Food Products | 13 | 2% |
Latest HEALTH C refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Khyati Global Ventures LimitedMumbai, India | Mustard oil, refined, single ingredient, see 28o for mustard oil as a flavoring | UNSAFE ADDHEALTH C | Source | |
| Hemani InternationalKarachi, Pakistan | Herbals & botanicals (not teas), n.e.c | DIETARYLBLLACKS FIRMNUTRIT LBL+1 | Source | |
| Indus Life Sciences Pvt LtdChennai, India | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLLABELINGNUTRIT LBL+1 | Source | |
| Pepsico India Holding Pvt LtdPune, India | Potato chips,fried | LIST INGRECOLOR LBLGLACKS FIRM+5 | Source | |
| Nestle India LtdNangal Kalan, India | Noodles and noodle products, n.e.c | LIST INGRECOLOR LBLGLACKS FIRM+4 | Source | |
| Ushas Nigerian ServicesLacros, Nigeria | Nonalcoholic beverages, n.e.c | HEALTH C | Source | |
| AVA Plant Co.,LtdBangkok, Thailand | Herbals & botanicals (not teas), n.e.c | HEALTH C | Source | |
| AVA Plant Co.,LtdBangkok, Thailand | Ashwagandha (herbal & botanicals, not teas) | HEALTH C | Source | |
| AVA Plant Co.,LtdBangkok, Thailand | Herbals & botanicals (not teas), n.e.c | HEALTH C | Source | |
| Lambac S.A.Guayas, Ecuador | Herbals & botanicals (not teas), n.e.c | LABELINGNUTRIT LBLHEALTH C | Source | |
| Lambac S.A.Guayas, Ecuador | Herbals & botanicals (not teas), n.e.c | HEALTH C | Source | |
| Nativo Trade S.R.L.Manoguayabo, Dominican Republic | Vitamin a | NOT LISTEDHEALTH C | Source | |
| Med Plants of Mexico AkDelegacion, Mexico | Foods with supplemental nutrients added, with or without artifical sweetners | NO ENGLISHDIETARYINGLABELING+1 | Source | |
| William XylitolUlsan, South Korea | Mineral n.e.c | LIST INGRENUTRIT LBLHEALTH C+1 | Source | |
| Infrasource ResourcesIsawo, Nigeria | Flours and meals n.e.c | LIST INGRELACKS N/CNUTRIT LBL+1 | Source | |
| Chanrai Brands LimitedTema, Ghana | Oleomargarine, n.e.c | LACKS N/CALLERGENNUTRIT LBL+1 | Source | |
| Sina Company IndonesiaDenpasar, Indonesia | Honey | FALSEHEALTH C | Source | |
| Nestle NigeriaIlupeju, Nigeria | Mixed cereal, quick or instant cooking | LIST INGREFALSELACKS N/C+2 | Source | |
| RDE Manufacturing Inc.Sarnia, Canada | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNCONTACTNUTRIT LBL+1 | Source | |
| RDE Manufacturing Inc.Sarnia, Canada | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNCONTACTNUTRIT LBL+1 | Source |
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.