Last refresh: . 26,358 refusals since 2020-01-01.

FDA refusal charge FRNMFGREG: foreign plant not registered

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The FRNMFGREG charge appeared in 135 FDA import refusals between 2020 and 2026 — 0.5% 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, Mexico, China. The most-affected product category is Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. Volume in 2025 was down 8% on 2024.

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What FDA's charge says

FRNMFGREG 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(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.

Sections 510(i); 801(o)

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Sections 502(o), 801(a)(3); MISBRANDING

FRNMFGREG refusals by year

YearRefusalsYoY
20205—
202111+120.0%
202212+9.1%
202336+200.0%
202425-30.6%
202523-8.0%
202623—YTD
Total135

Origins most often refused under FRNMFGREG

#Origin countryRefusals
1India35
2Mexico12
3China11
4Canada9
5United Kingdom6
6Germany5
7United Arab Emirates5
8Vietnam5
9Colombia4
10Indonesia4
11France3
12Nigeria3
13South Africa3
14Turkey3
15Dominican Republic2
16El Salvador2
17Guatemala2
18Honduras2
19Ivory Coast2
20Netherlands2
21Russia2
22Ukraine2
23United States2
24Brazil1
25Chile1
26Ghana1
27Iceland1
28Italy1
29South Korea1
30Spain1

Product categories refused under FRNMFGREG

#Product categoryRefusals
1Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans116
2Dietary Conventional Foods and Meal Replacements9
3Food Sweeteners (Nutritive)3
4Candy Without Chocolate, Candy Specialties, and Chewing Gum1
5Milk, Butter, and Dried Milk Products1
6Nuts and Edible Seeds1
7Snack Food Items (Flour, Meal, or Vegetable Base)1
8Soft Drinks and Waters1
9Spices, Flavors, and Salts1
10Whole Grains, Milled Grain Products, and Starch1

Latest refusals citing FRNMFGREG

About FRNMFGREG

What does the FDA import refusal charge FRNMFGREG mean?

FDA uses FRNMFGREG for: foreign plant not registered. Its published charge language reads: “The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.”

Is FRNMFGREG a food safety finding?

No. FRNMFGREG 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 FRNMFGREG?

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.