FDA refusal charge UNSAFE ADD: unsafe food additive

← All charge codes Unsafe additives Dashboard

The UNSAFE ADD charge appeared in 841 FDA import refusals between 2020 and 2026 — 4.4% of the 19,123 refusals that identify a hazard. The origins cited most often are India, Philippines, Mexico. The most-affected product category is Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet). Volume in 2025 was down 9% on 2024.

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What FDA's charge says

UNSAFE ADD 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) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
Sections 402(a)(2)(C)(i), 801(a)(3); ADULTERATION

UNSAFE ADD refusals by year

Year	Refusals	YoY
2020	53	—
2021	59	+11.3%
2022	70	+18.6%
2023	94	+34.3%
2024	259	+175.5%
2025	235	-9.3%
2026	71	—	YTD
Total	841

Origins most often refused under UNSAFE ADD

#	Origin country	Refusals
1	India	230
2	Philippines	191
3	Mexico	123
4	China	85
5	Malaysia	22
6	Turkey	17
7	Vietnam	16
8	Canada	15
9	Pakistan	13
10	Thailand	13
11	Bangladesh	12
12	Hong Kong	12
13	Guatemala	8
14	United Kingdom	7
15	Indonesia	5
16	Russia	5
17	South Korea	5
18	Spain	5
19	Ecuador	4
20	Japan	4
21	Egypt	3
22	France	3
23	Ghana	3
24	Jordan	3
25	Myanmar	3
26	Nepal	3
27	Taiwan	3
28	United Arab Emirates	3
29	Colombia	2
30	Nigeria	2

Show all 30 originsShow the top 10

Product categories refused under UNSAFE ADD

#	Product category	Refusals
1	Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet)	203
2	Vegetable Oils (Includes Olive Oil)	79
3	Fishery/Seafood Products	74
4	Nuts and Edible Seeds	74
5	Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans	72
6	Macaroni and Noodle Products	50
7	Fruit and Fruit Products	41
8	Milk, Butter, and Dried Milk Products	34
9	Bakery Products, Doughs, Bakery Mixes, and Icings	27
10	Candy Without Chocolate, Candy Specialties, and Chewing Gum	22
11	Food Sweeteners (Nutritive)	22
12	Dietary Conventional Foods and Meal Replacements	21
13	Soft Drinks and Waters	21
14	Spices, Flavors, and Salts	21
15	Snack Food Items (Flour, Meal, or Vegetable Base)	19

Latest refusals citing UNSAFE ADD

AEK-2025188-9 2026-10-07 PALM NUT ARECA, ARECA NUT OR BETEL NUT, SUBTROPICAL AND TROPICAL FRUITFrom India, Fruit and Fruit Products. unsafe food additive
KM6-3686052-0 2026-10-07 BETEL NUT, SHELLEDFrom India, Nuts and Edible Seeds. unsafe food additivepoisonous substanceunapproved new drug
WFB-0115702-2 2026-10-02 HERRINGFrom Finland, Fishery/Seafood Products. unsafe food additive
DP4-8687034-9 2026-09-29 BETEL NUT, IN SHELLFrom India, Nuts and Edible Seeds. filthSalmonellaunsafe food additivepoisonous substance
BNI-0147206-5 2026-09-29 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
AZ3-0121828-5 2026-09-24 MUSTARD OIL, REFINED, SINGLE INGREDIENT, SEE 28O FOR MUSTARD OIL AS A FLAVORINGFrom Bangladesh, Vegetable Oils (Includes Olive Oil). unsafe food additive
8P5-0098268-8 2026-09-16 SHRIMP & PRAWNSFrom China, Fishery/Seafood Products. unsafe food additiveveterinary drug residue
AQZ-0656461-4 2026-09-09 SHRIMP & PRAWNS, BREADEDFrom Malaysia, Fishery/Seafood Products. unsafe food additive
442-6877809-7 2026-09-02 MUSTARD OIL, REFINED, SINGLE INGREDIENT, SEE 28O FOR MUSTARD OIL AS A FLAVORINGFrom India, Vegetable Oils (Includes Olive Oil). unsafe food additiveunapproved new drug
AEK-9815893-2 2026-09-02 PALM NUT ARECA, ARECA NUT OR BETEL NUT, SUBTROPICAL AND TROPICAL FRUITFrom India, Fruit and Fruit Products. unsafe food additivepoisonous or deleterious substance
DP4-1069528-3 2026-09-01 CHILI SAUCEFrom India, Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet). ingredients not listedlabelingno food-canning registrationno process filing+4 more
AEK-2062503-3 2026-08-28 TEA, BLACKFrom India, Coffee and Tea. unsafe food additive
K64-3065737-4 2026-08-27 EELFrom China, Fishery/Seafood Products. unsafe food additiveveterinary drug residue
W69-5216310-4 2026-08-25 HERBALS & BOTANICALS (NOT TEAS), N.E.C.From China, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no adequate directionsunsafe food additivepoisonous or deleterious substanceunapproved new drug
AEK-0894584-1 2026-08-25 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. not in Englishunsafe food additiveunapproved new drug
DBD-0010064-2 2026-08-24 SHRIMP & PRAWNS, BREADEDFrom China, Fishery/Seafood Products. unsafe food additiveveterinary drug residue
K09-0100327-5 2026-08-21 SOFT CANDY WITH NUTS OR NUT PRODUCTS, N.E.C. (WITHOUT CHOCOLATE)From Turkey, Candy Without Chocolate, Candy Specialties, and Chewing Gum. unsafe food additivecolor not declaredunsafe color additive
KM6-3683555-5 2026-08-20 MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.From India, Spices, Flavors, and Salts. unsafe color additivesulfites not declaredunsafe food additivecolor not declared+2 more
BJG-0219758-9 2026-08-14 SAUCES, N.E.C.From Mexico, Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet). unsafe food additiveno food-canning registrationno process filing
9GX-0257348-2 2026-08-14 BETEL NUT, SHELLEDFrom India, Nuts and Edible Seeds. unsafe food additiveunsafe dietary usepoisonous substance

About UNSAFE ADD

What does the FDA import refusal charge UNSAFE ADD mean?

FDA uses UNSAFE ADD for: unsafe food additive. Its published charge language reads: “The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.”

Is UNSAFE ADD a food safety finding?

Yes. This site counts UNSAFE ADD as a hazard finding, so a refusal citing it is on the hazard side of the hazard and paperwork split, whatever else the refusal cites.

What happens to a shipment refused under UNSAFE ADD?

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.