Last refresh: . 26,358 refusals since 2020-01-01.

FDA refusal charge COLORLABEL: color additive labeling

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The COLORLABEL charge appeared in 103 FDA import refusals between 2020 and 2026 — 0.4% 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 Canada, India, Turkey. The most-affected product category is Candy Without Chocolate, Candy Specialties, and Chewing Gum. Volume in 2025 was down 5% on 2024.

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What FDA's charge says

COLORLABEL 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 appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use.

Sections 403(f);801(a)(3);MISBRANDING

COLORLABEL refusals by year

YearRefusalsYoY
20203—
20217+133.3%
202212+71.4%
202316+33.3%
202422+37.5%
202521-4.5%
202622—YTD
Total103

Origins most often refused under COLORLABEL

#Origin countryRefusals
1Canada14
2India11
3Turkey8
4China6
5Guatemala6
6Philippines6
7Sweden6
8Jordan5
9Colombia4
10Italy4
11Mexico4
12Pakistan4
13Honduras3
14Egypt2
15United States2
16Vietnam2
17Yemen2
18Australia1
19Brazil1
20Georgia1
21Germany1
22Hungary1
23Iran1
24Israel1
25Jamaica1
26Netherlands1
27Nigeria1
28Poland1
29Saudi Arabia1
30Spain1

Product categories refused under COLORLABEL

#Product categoryRefusals
1Candy Without Chocolate, Candy Specialties, and Chewing Gum22
2Fruit and Fruit Products14
3Snack Food Items (Flour, Meal, or Vegetable Base)14
4Bakery Products, Doughs, Bakery Mixes, and Icings10
5Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet)8
6Soft Drinks and Waters6
7Chocolate and Cocoa Products5
8Dressings and Condiments4
9Nuts and Edible Seeds3
10Spices, Flavors, and Salts3
11Beverage Bases2
12Color Additives for Foods, Drugs, and Cosmetics2
13Vegetables and Vegetable Products2
14Whole Grains, Milled Grain Products, and Starch2
15Cereal Preparations, Breakfast Foods1

Latest refusals citing COLORLABEL

About COLORLABEL

What does the FDA import refusal charge COLORLABEL mean?

FDA uses COLORLABEL for: color additive 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 appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use.”

Is COLORLABEL a food safety finding?

No. COLORLABEL 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 COLORLABEL?

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.