FDA refusal charge LABELING: labeling
← All charge codes Labelling Dashboard
The LABELING charge appeared in 746 FDA import refusals between 2020 and 2026 — 2.8% 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 Mexico, India, China. The most-affected product category is Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. Volume in 2025 was up 14% on 2024.
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What FDA's charge says
LABELING 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 in violation of FPLA because of its placement, form and/or contents statement.
LABELING refusals by year
| Year | Refusals | YoY | |
|---|---|---|---|
| 2020 | 86 | — | |
| 2021 | 70 | -18.6% | |
| 2022 | 74 | +5.7% | |
| 2023 | 111 | +50.0% | |
| 2024 | 130 | +17.1% | |
| 2025 | 148 | +13.8% | |
| 2026 | 127 | — | YTD |
| Total | 746 |
Origins most often refused under LABELING
| # | Origin country | Refusals |
|---|---|---|
| 1 | Mexico | 126 |
| 2 | India | 66 |
| 3 | China | 55 |
| 4 | Nigeria | 33 |
| 5 | Canada | 29 |
| 6 | Guatemala | 28 |
| 7 | United States | 20 |
| 8 | Indonesia | 18 |
| 9 | United Kingdom | 17 |
| 10 | Honduras | 16 |
| 11 | Turkey | 16 |
| 12 | Vietnam | 16 |
| 13 | Germany | 13 |
| 14 | Thailand | 12 |
| 15 | Japan | 11 |
| 16 | South Korea | 11 |
| 17 | Australia | 10 |
| 18 | Brazil | 10 |
| 19 | Malaysia | 10 |
| 20 | Portugal | 10 |
| 21 | Tanzania | 10 |
| 22 | Ecuador | 9 |
| 23 | Ghana | 9 |
| 24 | Haiti | 8 |
| 25 | Philippines | 8 |
| 26 | Sweden | 8 |
| 27 | Greece | 7 |
| 28 | Italy | 7 |
| 29 | Jordan | 7 |
| 30 | Spain | 7 |
Product categories refused under LABELING
| # | Product category | Refusals |
|---|---|---|
| 1 | Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans | 224 |
| 2 | Fishery/Seafood Products | 55 |
| 3 | Snack Food Items (Flour, Meal, or Vegetable Base) | 45 |
| 4 | Fruit and Fruit Products | 43 |
| 5 | Soft Drinks and Waters | 43 |
| 6 | Candy Without Chocolate, Candy Specialties, and Chewing Gum | 41 |
| 7 | Vegetables and Vegetable Products | 39 |
| 8 | Bakery Products, Doughs, Bakery Mixes, and Icings | 37 |
| 9 | Dietary Conventional Foods and Meal Replacements | 36 |
| 10 | Spices, Flavors, and Salts | 19 |
| 11 | Baby (Infant and Junior) Food Products | 17 |
| 12 | Coffee and Tea | 15 |
| 13 | Macaroni and Noodle Products | 15 |
| 14 | Nuts and Edible Seeds | 15 |
| 15 | Whole Grains, Milled Grain Products, and Starch | 15 |
Latest refusals citing LABELING
- 1FX-6292434-6 VITAMIN B1 (THIAMINE)From Guatemala, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. labeling
- AC1-0011017-3 FLAVORED OR PARTY CRACKERSFrom Thailand, Bakery Products, Doughs, Bakery Mixes, and Icings. not in Englishnutrition labelingno net quantitylabeling+1 more
- U72-0541035-1 TILAPIAFrom Nigeria, Fishery/Seafood Products. filthlabeling
- 9L9-0254322-7 CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)From Mexico, Candy Without Chocolate, Candy Specialties, and Chewing Gum. undeclared allergenlabelingnutrition labeling
- 02K-0000315-6 CRACKERS (NON FILLED) N.E.C.From Mexico, Bakery Products, Doughs, Bakery Mixes, and Icings. not in Englishlabeling
- H67-1725927-8 SOFT DRINK, COLA, CARBONATEDFrom India, Soft Drinks and Waters. no net quantitylabelingnutrition labeling
- 1FX-5690254-8 LOLLIPOP (WITHOUT CHOCOLATE)From Honduras, Candy Without Chocolate, Candy Specialties, and Chewing Gum. no manufacturer namerxlabellabelingnutrition labeling+1 more
- MH7-2120737-0 ANIMAL BY-PRODUCTS AND EXTRACTS, N.E.C.From Indonesia, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. not in EnglishlabelingSalmonella
- 1FX-1906165-4 TODDLER MILK BASED FORMULA/DRINK PRODUCT (12-36 MONTHS), POWDER FORMULAFrom Denmark, Baby (Infant and Junior) Food Products. labeling
- BNI-0147206-5 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Ghana, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. unsafe food additivelabelingunapproved new drug
- 1FX-5191937-2 JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)From Sweden, Candy Without Chocolate, Candy Specialties, and Chewing Gum. ingredients not listedlabel not conspicuouscolor not declaredno manufacturer name+6 more
- EEE-0104266-1 CHEWING GUM (WITHOUT CHOCOLATE)From Mexico, Candy Without Chocolate, Candy Specialties, and Chewing Gum. unsafe color additiveingredients not listedlabel not conspicuouscolor not declared+5 more
- 1FX-2339712-9 FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERSFrom Israel, Dietary Conventional Foods and Meal Replacements. supplement labelingno net quantitynot in Englishlabeling+1 more
- BDD-0733969-6 NOODLES AND NOODLE PRODUCTS, N.E.C.From Philippines, Macaroni and Noodle Products. unsafe color additivecolor not declaredlabelingno process filing
- 8Q4-0009450-9 SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATEDFrom Guatemala, Soft Drinks and Waters. unsafe color additivenot to standard of identityno net quantitynot in English+3 more
- BJG-0220621-6 POTATO CHIPS,FRIEDFrom Mexico, Snack Food Items (Flour, Meal, or Vegetable Base). unsafe color additiveingredients not listedlabel not conspicuouscolor not declared+3 more
- 1FX-4115554-0 CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)From Germany, Candy Without Chocolate, Candy Specialties, and Chewing Gum. labelingnutrition labeling
- BJG-0221598-5 CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)From Mexico, Candy Without Chocolate, Candy Specialties, and Chewing Gum. labelingnutrition labeling
- ENS-0103435-6 MILK, PLAINFrom Poland, Milk, Butter, and Dried Milk Products. no common namelabelingnutrition labelingno process filing
- BJG-0216869-7 ORAL REHYDRATION PRODUCTSFrom Mexico, Dietary Conventional Foods and Meal Replacements. ingredients not listedlabel not conspicuousfalse or misleading labelnot in English+3 more
About LABELING
What does the FDA import refusal charge LABELING mean?
FDA uses LABELING for: labeling. Its published charge language reads: “The article appears in violation of FPLA because of its placement, form and/or contents statement.”
Is LABELING a food safety finding?
No. LABELING 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 LABELING?
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.