FDA refusal charge
FDA refusal charge UNSAFE ADD
Food additive unsafe under section 409
UNSAFE ADD is the FDA import refusal charge for food additive unsafe under section 409; it cites sections 402(a)(2)(C)(i) and 801(a)(3) of the FD&C Act (adulteration). FDA recorded it on 2,275 refused shipment lines between October 2016 and October 9, 2026, most often for sauces and prepared meals from Philippines.
Data from FDA public records, last checked .
- 2,275
- refused shipment lines carry this charge
- 56
- countries of origin
- 9
- import alerts name this charge
What UNSAFE ADD means
The product appeared to contain a food additive that is unsafe within the meaning of section 409 of the FD&C Act, the section that governs which food additives may be used and under what conditions.
This restates FDA's statement. It says what the charge means, never why a particular shipment was refused.
- FD&C Act section
- 402(a)(2)(C)(i)801(a)(3)
- Classification
- adulteration
FDA's official statement
Copied unchanged from FDA's Refusal Charges reference table.
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.
Import alerts that name UNSAFE ADD
The charge section of each alert names this code. An alert lists firms; a charge is the reason recorded on one refused line.
| Alert | Covers | Red | Green |
|---|---|---|---|
| 99-45 | Foods that are or contain an unsafe food additive | 133 | |
| 54-16 | Foods/supplements with active pharmaceutical ingredient | 98 | |
| 36-04 | Honey and blended syrup: drug residues | 53 | |
| 45-06 | Stevia leaves, crude extracts and foods containing them | 21 | |
| 16-131 | Aquacultured, shrimp, dace, and eel from China and Hong Kong | 20 | |
| 26-04 | Expressed Mustard Oil | 1 | |
| 72-06 | Cat food products due to the presence of propylene glycol | 1 | |
| 16-136 | Aquacultured shrimp and prawns from Peninsular Malaysia | ||
| 23-15 | Foods and supplements containing areca (betel) nuts |
Countries with the most UNSAFE ADD refusals
Shipment lines carrying UNSAFE ADD, by country of origin.
| Country | Lines | Share of UNSAFE ADD |
|---|---|---|
| Philippines | 634 | 28% |
| India | 449 | 20% |
| Mexico | 348 | 15% |
| China | 339 | 15% |
| South Korea | 55 | 2% |
| Canada | 52 | 2% |
| Russia | 38 | 2% |
| Vietnam | 33 | 1% |
| Malaysia | 29 | 1% |
| Pakistan | 28 | 1% |
Product categories with the most UNSAFE ADD refusals
| Category | Lines | Share of UNSAFE ADD |
|---|---|---|
| Multiple Food Dinners, Gravies, Sauces, and Specialties | 648 | 28% |
| Fishery/Seafood Products | 231 | 10% |
| Vegetable Oils (Includes Olive Oil) | 185 | 8% |
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 158 | 7% |
| Fruit and Fruit Products (pit, subtropical and tropical fruits) | 142 | 6% |
| Nuts and Edible Seeds | 127 | 6% |
| Dietary Conventional Foods and Meal Replacements | 120 | 5% |
| Macaroni and Noodle Products | 97 | 4% |
| Soft Drinks and Waters | 72 | 3% |
| Snack Food Items | 56 | 2% |
Latest UNSAFE ADD refusals
The 20 most recent refused lines, through October 9, 2026, each with its FDA source.
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Procesadora de Dulces Tipicos, S.A. de C.V.Guadalajara, Mexico | Candy specialties, n.e.c. (without chocolate) | UNSAFE ADD | Source | |
| Procesadora de Dulces Tipicos, S.A. de C.V.Guadalajara, Mexico | Candy specialties, n.e.c. (without chocolate) | UNSAFE ADD | Source | |
| Procesadora de Dulces Tipicos, S.A. de C.V.Guadalajara, Mexico | Candy specialties, n.e.c. (without chocolate) | UNSAFE ADD | Source | |
| Procesadora de Dulces Tipicos, S.A. de C.V.Guadalajara, Mexico | Candy specialties, n.e.c. (without chocolate) | UNSAFE ADD | Source | |
| Rudra EximGuntur, India | Betel nut, in shell | UNSAFE ADDPOISONORD | Source | |
| Rudra EximGuntur, India | Betel nut, in shell | UNSAFE ADDPOISONORD | Source | |
| Rudra EximGuntur, India | Betel nut, in shell | UNSAFE ADDPOISONORD | Source | |
| Sanchi EnterpriseSiliguri, India | Palm nut Areca, areca nut or betel nut, subtropical and tropical fruit | UNSAFE ADD | Source | |
| Satvedic ResourcesSurat, India | Betel nut, shelled | UNSAFE ADDPOISONORD | Source | |
| Suomen SillikonttoriRoola, Finland | Herring | UNSAFE ADD | Source | |
| Kasapreko Company LimitedAccra, Ghana | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNSAFE ADD | Source | |
| Tanveer Food LimitedNarayangonj, Bangladesh | Mustard oil, refined, single ingredient, see 28o for mustard oil as a flavoring | UNSAFE ADD | Source | |
| Rudong Zhengxiong Trade Co.,LtdNantong, China | Shrimp & prawns | UNSAFE ADDVETDRUGRES | Source | |
| Golden Fresh Sdn BhdButterworth, Malaysia | Shrimp & prawns, breaded | UNSAFE ADD | Source | |
| Golden Fresh Sdn BhdButterworth, Malaysia | Shrimp & prawns, breaded | UNSAFE ADD | Source | |
| Golden Fresh Sdn BhdButterworth, Malaysia | Shrimp & prawns, breaded | UNSAFE ADD | Source | |
| Golden Fresh Sdn BhdButterworth, Malaysia | Shrimp & prawns, breaded | UNSAFE ADD | Source | |
| Vivus VitaPalwal, India | Mustard oil, refined, single ingredient, see 28o for mustard oil as a flavoring | UNSAFE ADDUNAPPROVED | Source | |
| Sanchi EnteroriseDarjeeling, India | Palm nut Areca, areca nut or betel nut, subtropical and tropical fruit | UNSAFE ADDPOISONOUS | Source | |
| Khyati Global Ventures LimitedMumbai, India | Mustard oil, refined, single ingredient, see 28o for mustard oil as a flavoring | UNSAFE ADDHEALTH C | Source |
Questions about UNSAFE ADD
- What does UNSAFE ADD mean on an FDA refusal?
- UNSAFE ADD is the refusal charge “Food additive unsafe under section 409”. The product appeared to contain a food additive that is unsafe within the meaning of section 409 of the FD&C Act, the section that governs which food additives may be used and under what conditions.
- What law does UNSAFE ADD cite?
- FDA's refusal charge table cites sections 402(a)(2)(C)(i) and 801(a)(3) of the FD&C Act (adulteration) for UNSAFE ADD, and classifies the charge as adulteration. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
- Which countries have the most UNSAFE ADD refusals?
- As of October 26, 2026, the countries with the most UNSAFE ADD refusal lines are Philippines (634), India (449) and Mexico (348). The full list with links is in the table on this page.
- Is there an FDA import alert for UNSAFE ADD?
- Yes. 9 FDA import alerts name UNSAFE ADD as a charge code, including Import Alert 99-45 (Foods that are or contain an unsafe food additive), Import Alert 54-16 (Foods/supplements with active pharmaceutical ingredient), Import Alert 36-04 (Honey and blended syrup: drug residues) and Import Alert 45-06 (Stevia leaves, crude extracts and foods containing them). An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.
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