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.

Sections 403(s)(2)(C), 801(a)(3); MISBRANDING

PLANT PART refusals by year

YearRefusalsYoY
20206—
20216+0.0%
20223-50.0%
20238+166.7%
20248+0.0%
20255-37.5%
20267—YTD
Total43

Origins most often refused under PLANT PART

#Origin countryRefusals
1India7
2Hong Kong6
3China4
4Germany4
5Mexico4
6Saint Lucia3
7United Kingdom3
8Canada2
9Taiwan2
10Armenia1
11Austria1
12Brazil1
13Chile1
14South Africa1
15South Korea1
16Ukraine1
17United States1

Product categories refused under PLANT PART

#Product categoryRefusals
1Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans33
2Dietary Conventional Foods and Meal Replacements10

Latest refusals citing PLANT PART

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.