FDA refusal charge DIETARYLBL: supplement labeling
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The DIETARYLBL charge appeared in 351 FDA import refusals between 2020 and 2026 — 1.3% 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, Canada, United Kingdom. The most-affected product category is Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. Volume in 2025 was down 45% on 2024.
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What FDA's charge says
DIETARYLBL 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)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
DIETARYLBL refusals by year
| Year | Refusals | YoY | |
|---|---|---|---|
| 2020 | 44 | — | |
| 2021 | 41 | -6.8% | |
| 2022 | 38 | -7.3% | |
| 2023 | 57 | +50.0% | |
| 2024 | 80 | +40.4% | |
| 2025 | 44 | -45.0% | |
| 2026 | 47 | — | YTD |
| Total | 351 |
Origins most often refused under DIETARYLBL
| # | Origin country | Refusals |
|---|---|---|
| 1 | India | 50 |
| 2 | Canada | 39 |
| 3 | United Kingdom | 32 |
| 4 | China | 21 |
| 5 | Mexico | 21 |
| 6 | United States | 19 |
| 7 | South Korea | 15 |
| 8 | Japan | 13 |
| 9 | Malaysia | 12 |
| 10 | Vietnam | 11 |
| 11 | Hong Kong | 9 |
| 12 | Australia | 7 |
| 13 | Thailand | 7 |
| 14 | Italy | 6 |
| 15 | Brazil | 5 |
| 16 | Germany | 5 |
| 17 | Nigeria | 5 |
| 18 | Saint Lucia | 5 |
| 19 | Turkey | 5 |
| 20 | Ghana | 4 |
| 21 | Israel | 4 |
| 22 | Pakistan | 4 |
| 23 | South Africa | 4 |
| 24 | Lithuania | 3 |
| 25 | Netherlands | 3 |
| 26 | Poland | 3 |
| 27 | Portugal | 3 |
| 28 | Spain | 3 |
| 29 | Austria | 2 |
| 30 | Bahamas | 2 |
Product categories refused under DIETARYLBL
| # | Product category | Refusals |
|---|---|---|
| 1 | Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans | 282 |
| 2 | Dietary Conventional Foods and Meal Replacements | 39 |
| 3 | Coffee and Tea | 5 |
| 4 | Vegetables and Vegetable Products | 4 |
| 5 | Candy Without Chocolate, Candy Specialties, and Chewing Gum | 3 |
| 6 | Food Sweeteners (Nutritive) | 3 |
| 7 | Spices, Flavors, and Salts | 3 |
| 8 | Soft Drinks and Waters | 2 |
| 9 | Whole Grains, Milled Grain Products, and Starch | 2 |
| 10 | Bakery Products, Doughs, Bakery Mixes, and Icings | 1 |
| 11 | Beverage Bases | 1 |
| 12 | Cereal Preparations, Breakfast Foods | 1 |
| 13 | Chocolate and Cocoa Products | 1 |
| 14 | Fruit and Fruit Products | 1 |
| 15 | Macaroni and Noodle Products | 1 |
Latest refusals citing DIETARYLBL
- AC1-0011017-3 FLAVORED OR PARTY CRACKERSFrom Thailand, Bakery Products, Doughs, Bakery Mixes, and Icings. not in Englishnutrition labelingno net quantitylabeling+1 more
- 1FX-7482640-5 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Saint Lucia, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingdietary ingredient labelingplant part not declaredno contact information+2 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
- 1FX-1166477-9 VITAMIN, N.E.C.From Guatemala, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingnot in English
- 1FX-0668404-8 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Mexico, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingnot in Englishnutrition labeling
- DS9-2513624-6 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Canada, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingnutrition labeling
- AEK-9759966-4 COFFEE, N.E.C.From Malaysia, Coffee and Tea. supplement labeling
- AEK-0890916-9 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From China, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. ingredients not listedsupplement labelingno manufacturer namelabeling+1 more
- EF3-0564875-2 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From India, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelinglabelingnutrition labelingunauthorized health claim
- KM6-1640199-8 HERBALS & BOTANICALS (NOT TEAS), N.E.C.From Pakistan, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. ingredients not listednot in Englishsupplement labelingno manufacturer name+2 more
- 1FX-0133126-4 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Saint Lucia, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingdietary ingredient labelingplant part not declaredunapproved new drug
- 1FX-1735255-0 HERBALS & BOTANICALS (NOT TEAS), N.E.C.From Lithuania, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingno manufacturer namelabeling
- INL-1254517-1 GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALSFrom China, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingSiberian ginseng mislabeleddietary ingredient labelingno contact information
- 1FX-3323262-0 GLYCINE (PROTEIN)From Malaysia, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingdietary ingredient labeling
- 1FX-6651417-5 MAGNESIUM (MINERAL)From Lithuania, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. ingredients not listedsupplement labelingundeclared allergennutrition labeling
- AEK-0817631-4 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From United Kingdom, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingdietary ingredient labeling
- AEK-0878033-9 ZINC (MINERAL)From Austria, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingfalse or misleading labelnutrition labeling
- 8B4-0012404-4 VITAMIN, N.E.C.From Senegal, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingno contact information
- 9AJ-0014962-8 HERBALS & BOTANICALS (NOT TEAS), N.E.C.From Ukraine, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingno contact information
- 8VH-2600085-4 VERVAIN (HERBAL & BOTANICALS, NOT TEAS)From Saint Lucia, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no adequate directionssupplement labelingplant part not declarednutrition labeling+1 more
About DIETARYLBL
What does the FDA import refusal charge DIETARYLBL mean?
FDA uses DIETARYLBL for: supplement labeling. 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)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.”
Is DIETARYLBL a food safety finding?
No. DIETARYLBL 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 DIETARYLBL?
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.