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.

Sections 403(s)(2)(B), 801(a)(3), misbranded

DIETARYLBL refusals by year

YearRefusalsYoY
202044—
202141-6.8%
202238-7.3%
202357+50.0%
202480+40.4%
202544-45.0%
202647—YTD
Total351

Origins most often refused under DIETARYLBL

#Origin countryRefusals
1India50
2Canada39
3United Kingdom32
4China21
5Mexico21
6United States19
7South Korea15
8Japan13
9Malaysia12
10Vietnam11
11Hong Kong9
12Australia7
13Thailand7
14Italy6
15Brazil5
16Germany5
17Nigeria5
18Saint Lucia5
19Turkey5
20Ghana4
21Israel4
22Pakistan4
23South Africa4
24Lithuania3
25Netherlands3
26Poland3
27Portugal3
28Spain3
29Austria2
30Bahamas2

Product categories refused under DIETARYLBL

#Product categoryRefusals
1Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans282
2Dietary Conventional Foods and Meal Replacements39
3Coffee and Tea5
4Vegetables and Vegetable Products4
5Candy Without Chocolate, Candy Specialties, and Chewing Gum3
6Food Sweeteners (Nutritive)3
7Spices, Flavors, and Salts3
8Soft Drinks and Waters2
9Whole Grains, Milled Grain Products, and Starch2
10Bakery Products, Doughs, Bakery Mixes, and Icings1
11Beverage Bases1
12Cereal Preparations, Breakfast Foods1
13Chocolate and Cocoa Products1
14Fruit and Fruit Products1
15Macaroni and Noodle Products1

Latest refusals citing DIETARYLBL

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.