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FDA refusal charge

FDA refusal charge LABELING

Fair Packaging and Labeling Act

LABELING is the FDA import refusal charge for Fair Packaging and Labeling Act; it cites section Section 4(a) of the FD&C Act (801(a)(3) misbranding). FDA recorded it on 3,323 refused shipment lines between October 2016 and October 15, 2026, most often for dietary supplements from Mexico.

Data from FDA public records, last checked .

3,323
refused shipment lines carry this charge
112
countries of origin
0
import alerts name this charge

What LABELING means

The package appeared not to meet the Fair Packaging and Labeling Act because of the placement, form, or contents of a required label statement.

This restates FDA's statement. It says what the charge means, never why a particular shipment was refused.

FD&C Act section
Section 4(a)
Classification
801(a)(3) misbranding

FDA's official statement

Copied unchanged from FDA's Refusal Charges reference table.
The article appears in violation of FPLA because of its placement, form and/or contents statement.
LABELING · Section 4(a); 801(a)(3) MisbrandingFDA reference table (CSV)

Countries with the most LABELING refusals

Shipment lines carrying LABELING, by country of origin.
LABELING refusal lines by country
CountryLinesShare of LABELING
Mexico57717%
India2558%
China2086%
Nigeria1876%
Guatemala1494%
Russia1234%
Canada1123%
Brazil1043%
United Kingdom983%
South Korea863%

Product categories with the most LABELING refusals

LABELING refusal lines by product category
CategoryLinesShare of LABELING
Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties77623%
Snack Food Items3129%
Bakery Products, Doughs, Bakery Mixes, and Icings2608%
Soft Drinks and Waters2257%
Candy without Chocolate, Candy Specialties, and Chewing Gum2106%
Fishery/Seafood Products1815%
Spices, Flavors, and Salts1414%
Fruit and Fruit Products (pit, subtropical and tropical fruits)1214%
Chocolate and Cocoa Products943%
Vegetables and Vegetable Products (root and tuber vegetables, fungi)832%

Latest LABELING refusals

The 20 most recent refused lines, through October 15, 2026, each with its FDA source.
Latest FDA refusals carrying LABELING
DateFirmProductCharges
Advanced Nordic Nutrition APSEbberup, DenmarkMilk base infant formula product (0-12 months), powder formulaNO ENGLISHLABELINGNUTRIT LBLSource
Infrasource ResourcesIsawo, NigeriaFish, n.e.cFILTHYFALSEALLERGEN+2Source
Farmamedica, S.A.Guatemala, GuatemalaVitamin b1 (thiamine)LABELINGSource
Mae Khem Co LtdMae Sot, ThailandFlavored or party crackersLACKS N/CLABELINGSource
Amgray Global Services, Inc.Ikeja, NigeriaTilapiaFILTHYLABELINGSource
Bimbo, S.A de C.V.Cuauhtemoc, MexicoFruit/fruit flavored plain cookies, biscuits and wafersLABELINGNUTRIT LBLSource
Productos Ricolino, S.A.P.I. deCiudad De M Xico, MexicoCandy specialties, n.e.c. (without chocolate)ALLERGENLABELINGNUTRIT LBLSource
Productos Ricolino, S.A.P.I. deCiudad De M Xico, MexicoSoft candy with fruit, n.e.c. (without chocolate)LABELINGNUTRIT LBLSource
Productos Ricolino, S.A.P.I. deCiudad De M Xico, MexicoCandy specialties, n.e.c. (without chocolate)LABELINGNUTRIT LBLSource
Mondelez Mexico, S. de R.L. de C.V.Ciudad De Mexico, MexicoChocolate chip cookie, biscuit,wafer doughNO ENGLISHLABELINGSource
Sosyo Hajoori Beverages Private LimitedChorasi, IndiaSoft drink, cola, carbonatedLABELINGNUTRIT LBLSource
Mondelez Mexico, S. de R.L. de C.V.Ciudad De Mexico, MexicoChocolate chip cookie, biscuit,wafer doughNO ENGLISHLABELINGSource
Sosyo Hajoori Beverages Private LimitedChorasi, IndiaSoft drink, cola, carbonatedLABELINGNUTRIT LBLSource
Mondelez Mexico, S. de R.L. de C.V.Ciudad De Mexico, MexicoCrackers (non filled) n.e.cNO ENGLISHLABELINGSource
Mondelez Mexico, S. de R.L. de C.V.Ciudad De Mexico, MexicoCrackers (non filled) n.e.cNO ENGLISHLABELINGSource
American VitalabNa, GuatemalaVitamin b12 (cyanocobalamin)RXLABELLABELINGSource
Piersan Centroamericana, S.A.Unknown, GuatemalaVitamin b12 (cyanocobalamin)LACKS FIRMRXLABELLABELINGSource
CV Anugerah UtamaSurabaya, IndonesiaAnimal by-products and extracts, n.e.cNO ENGLISHLABELINGSALMONELLASource
Advanced Nordic Nutrition APSEbberup, DenmarkToddler milk based formula/drink product (12-36 months), powder formulaLABELINGSource
Bullion Go-Neat Global LtdIbafo, NigeriaVitamin, n.e.cLABELINGUNAPPROVEDSource

Questions about LABELING

What does LABELING mean on an FDA refusal?
LABELING is the refusal charge “Fair Packaging and Labeling Act”. The package appeared not to meet the Fair Packaging and Labeling Act because of the placement, form, or contents of a required label statement.
What law does LABELING cite?
FDA's refusal charge table cites section Section 4(a) of the FD&C Act (801(a)(3) misbranding) for LABELING, and classifies the charge as 801(a)(3) misbranding. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
Which countries have the most LABELING refusals?
As of October 25, 2026, the countries with the most LABELING refusal lines are Mexico (577), India (255) and China (208). The full list with links is in the table on this page.
Is there an FDA import alert for LABELING?
SupplierRadar found no food import alert whose charge section names LABELING. An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.