FDA refusal charge PLANT PART: plant part not declared
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The PLANT PART charge appeared in 43 FDA import refusals between 2020 and 2026 — 0.2% 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, Hong Kong, China. The most-affected product category is Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. Volume in 2025 was down 38% on 2024.
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What FDA's charge says
PLANT PART 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) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived.
PLANT PART refusals by year
| Year | Refusals | YoY | |
|---|---|---|---|
| 2020 | 6 | — | |
| 2021 | 6 | +0.0% | |
| 2022 | 3 | -50.0% | |
| 2023 | 8 | +166.7% | |
| 2024 | 8 | +0.0% | |
| 2025 | 5 | -37.5% | |
| 2026 | 7 | — | YTD |
| Total | 43 |
Origins most often refused under PLANT PART
| # | Origin country | Refusals |
|---|---|---|
| 1 | India | 7 |
| 2 | Hong Kong | 6 |
| 3 | China | 4 |
| 4 | Germany | 4 |
| 5 | Mexico | 4 |
| 6 | Saint Lucia | 3 |
| 7 | United Kingdom | 3 |
| 8 | Canada | 2 |
| 9 | Taiwan | 2 |
| 10 | Armenia | 1 |
| 11 | Austria | 1 |
| 12 | Brazil | 1 |
| 13 | Chile | 1 |
| 14 | South Africa | 1 |
| 15 | South Korea | 1 |
| 16 | Ukraine | 1 |
| 17 | United States | 1 |
Product categories refused under PLANT PART
| # | Product category | Refusals |
|---|---|---|
| 1 | Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans | 33 |
| 2 | Dietary Conventional Foods and Meal Replacements | 10 |
Latest refusals citing PLANT PART
- 1FX-7482640-5 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Saint Lucia, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingdietary ingredient labelingplant part not declaredno contact information+2 more
- 1FX-0133126-4 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Saint Lucia, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingdietary ingredient labelingplant part not declaredunapproved new drug
- 8VH-2600085-4 VERVAIN (HERBAL & BOTANICALS, NOT TEAS)From Saint Lucia, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no adequate directionssupplement labelingplant part not declarednutrition labeling+1 more
- EUX-0137633-4 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Hong Kong, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. label not conspicuousno manufacturer nameplant part not declaredno contact information+2 more
- EUX-0138318-1 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Hong Kong, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingno manufacturer namenot in Englishplant part not declared+3 more
- EUX-0137848-8 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Hong Kong, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no manufacturer namenot in Englishdietary ingredient labelingplant part not declared+1 more
- 918-5423622-0 HERBALS & BOTANICALS (NOT TEAS), N.E.C.From Mexico, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. ingredients not listedsupplement labelingplant part not declared
- 349-2068359-5 HERBALS & BOTANICALS (NOT TEAS), N.E.C.From China, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. ingredients not listedfalse or misleading labelnot in Englishplant part not declared+1 more
- SCS-9375461-6 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From United States, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. ingredients not listedsupplement labelingplant part not declaredunapproved new drug
- SCS-9273266-2 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. plant part not declared
- SCS-9273895-8 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. plant part not declared
- BPQ-7050200-5 GINSENG (HERBAL & BOTANICALS, NOT TEAS)From United Kingdom, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. ingredients not listedsupplement labelingplant part not declarednutrition labeling+1 more
- SCS-6934913-6 DIETARY CONVENTIONAL FOODS, N.E.C.From India, Dietary Conventional Foods and Meal Replacements. supplement GMP failureplant part not declared
- W69-5120387-7 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From China, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. ingredients not listedfalse or misleading labelplant part not declarednutrition labeling+1 more
- SCS-5711468-2 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Canada, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingdietary ingredient labelingplant part not declaredno contact information+1 more
- AEK-5752729-1 DIETARY CONVENTIONAL FOODS, N.E.C.From India, Dietary Conventional Foods and Meal Replacements. supplement GMP failureplant part not declared
- AEK-5752730-9 DIETARY CONVENTIONAL FOODS, N.E.C.From India, Dietary Conventional Foods and Meal Replacements. supplement GMP failureplant part not declared
- EUX-0135392-9 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Hong Kong, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no manufacturer namedietary ingredient labelingplant part not declaredno contact information+1 more
- EUX-0135393-7 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Hong Kong, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelinglabel not conspicuousno manufacturer namedietary ingredient labeling+4 more
- 799-8929012-7 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From South Africa, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no standard nameplant part not declared
About PLANT PART
What does the FDA import refusal charge PLANT PART mean?
FDA uses PLANT PART for: plant part not declared. Its published charge language reads: “The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived.”
Is PLANT PART a food safety finding?
No. PLANT PART 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 PLANT PART?
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.