FDA refusal charge SUPPL GMP: supplement GMP failure
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The SUPPL GMP charge appeared in 165 FDA import refusals between 2020 and 2026 — 0.6% 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, United Kingdom, Mexico. The most-affected product category is Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. Volume in 2025 was up 145% on 2024.
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What FDA's charge says
SUPPL GMP 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 appears to be a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.
SUPPL GMP refusals by year
| Year | Refusals | YoY | |
|---|---|---|---|
| 2020 | 10 | — | |
| 2021 | 10 | +0.0% | |
| 2022 | 10 | +0.0% | |
| 2023 | 12 | +20.0% | |
| 2024 | 20 | +66.7% | |
| 2025 | 49 | +145.0% | |
| 2026 | 54 | — | YTD |
| Total | 165 |
Origins most often refused under SUPPL GMP
| # | Origin country | Refusals |
|---|---|---|
| 1 | India | 49 |
| 2 | United Kingdom | 30 |
| 3 | Mexico | 23 |
| 4 | Canada | 18 |
| 5 | Australia | 8 |
| 6 | Dominican Republic | 6 |
| 7 | Japan | 6 |
| 8 | Germany | 5 |
| 9 | Brazil | 4 |
| 10 | Denmark | 4 |
| 11 | Fiji | 3 |
| 12 | China | 2 |
| 13 | Iceland | 2 |
| 14 | New Zealand | 2 |
| 15 | Indonesia | 1 |
| 16 | Malaysia | 1 |
| 17 | Thailand | 1 |
Product categories refused under SUPPL GMP
| # | Product category | Refusals |
|---|---|---|
| 1 | Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans | 119 |
| 2 | Dietary Conventional Foods and Meal Replacements | 27 |
| 3 | Coffee and Tea | 12 |
| 4 | Candy Without Chocolate, Candy Specialties, and Chewing Gum | 3 |
| 5 | Milk, Butter, and Dried Milk Products | 2 |
| 6 | Macaroni and Noodle Products | 1 |
| 7 | Meat, Meat Products, and Poultry | 1 |
Latest refusals citing SUPPL GMP
- EPM-0196215-4 HERBALS & BOTANICALS (NOT TEAS), N.E.C.From Japan, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement GMP failure
- AEK-2075273-8 DIETARY CONVENTIONAL FOODS, N.E.C.From India, Dietary Conventional Foods and Meal Replacements. supplement GMP failure
- AEK-9852351-5 DIETARY CONVENTIONAL FOODS, N.E.C.From India, Dietary Conventional Foods and Meal Replacements. supplement GMP failure
- AEK-0869557-8 DIETARY CONVENTIONAL FOODS, N.E.C.From Australia, Dietary Conventional Foods and Meal Replacements. supplement GMP failure
- AEK-0869578-4 VITAMIN, N.E.C.From Australia, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement GMP failure
- 9XP-0044546-9 BIOFLAVANOIDS (VIT/MIN?PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)From United Kingdom, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement GMP failure
- AEK-0734831-0 MECOBALAMIN (VITAMIN)From China, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement GMP failure
- AEK-0552043-1 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From India, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement GMP failure
- AEK-0481065-0 MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)From India, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement GMP failureunapproved new drug
- AEK-0869582-6 VITAMIN, N.E.C.From Australia, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement GMP failure
- AEK-0869585-9 VITAMIN, N.E.C.From Australia, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement GMP failure
- AEK-0552083-7 CHOLINE (MINERAL)From India, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement GMP failure
- 788-1925541-1 HERBALS & BOTANICALS (NOT TEAS), N.E.C.From Japan, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement GMP failure
- W96-3608011-6 VERMICELLIFrom Thailand, Macaroni and Noodle Products. supplement GMP failureFSVP violation
- 1FX-9301323-2 VITAMIN C (ASCORBIC ACID)From Mexico, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement GMP failure
- AEK-0553015-8 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From India, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement GMP failure
- NRN-0002417-5 PROBIOTICS (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)From Australia, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement GMP failure
- 739-9020920-4 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From New Zealand, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement GMP failure
- KM6-3672303-3 HERBALS & BOTANICALS (NOT TEAS), N.E.C.From India, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement GMP failure
- 1FX-4340553-8 GLUCOSAMINE HYDROCHLORIDE (HERBAL AND BOTANICALS, NOT TEAS II)From Mexico, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement GMP failure
About SUPPL GMP
What does the FDA import refusal charge SUPPL GMP mean?
FDA uses SUPPL GMP for: supplement GMP failure. Its published charge language reads: “The article appears to be a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.”
Is SUPPL GMP a food safety finding?
No. SUPPL GMP 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 SUPPL GMP?
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.