FDA refusal charge MELAMINE: melamine

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The MELAMINE charge appeared in 611 FDA import refusals between 2020 and 2026 — 3.2% of the 19,123 refusals that identify a hazard. The origins cited most often are China, Hong Kong, Philippines. The most-affected product category is Bakery Products, Doughs, Bakery Mixes, and Icings. Volume in 2025 was up 82% on 2024.

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What FDA's charge says

MELAMINE 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 bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of Section 409.

Sections 402(a)(1), 801(a)(3), Adulteration

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409.

Sections 402(a)(2)(C)(i), 801(a)(3); ADULTERATION

The article is subject to refusal of admission in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409.

Sections 402(a)(2)(C)(i), 801(a)(3); ADULTERATION

MELAMINE refusals by year

YearRefusalsYoY
202083—
202144-47.0%
202246+4.5%
202342-8.7%
202476+81.0%
2025138+81.6%
2026182—YTD
Total611

Origins most often refused under MELAMINE

#Origin countryRefusals
1China601
2Hong Kong6
3Philippines1
4South Korea1
5Taiwan1
6Vietnam1

Product categories refused under MELAMINE

#Product categoryRefusals
1Bakery Products, Doughs, Bakery Mixes, and Icings217
2Ice Cream and Related Products125
3Snack Food Items (Flour, Meal, or Vegetable Base)64
4Milk, Butter, and Dried Milk Products43
5Vegetable Protein Products (Simulated Meats)37
6Whole Grains, Milled Grain Products, and Starch31
7Chocolate and Cocoa Products26
8Soft Drinks and Waters16
9Beverage Bases8
10Candy Without Chocolate, Candy Specialties, and Chewing Gum7
11Cereal Preparations, Breakfast Foods6
12Filled Milk and Imitation Milk Products6
13Fruit and Fruit Products6
14Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans4
15Coffee and Tea3

Latest refusals citing MELAMINE

About MELAMINE

What does the FDA import refusal charge MELAMINE mean?

FDA uses MELAMINE for: melamine. Its published charge language reads: “The article appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of Section 409.”

Is MELAMINE a food safety finding?

Yes. This site counts MELAMINE as a hazard finding, so a refusal citing it is on the hazard side of the hazard and paperwork split, whatever else the refusal cites.

What happens to a shipment refused under MELAMINE?

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.