FDA refusal charge SUBSTITUTE: substitution
The SUBSTITUTE charge appeared in 41 FDA import refusals between 2020 and 2026 — 0.2% of all 26,358 US import refusals. The origins cited most often are Mexico, India, Italy. The most-affected product category is Food Sweeteners (Nutritive). Volume in 2025 was up 0% on 2024.
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What FDA's charge says
SUBSTITUTE 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 that a substance has been substituted wholly or in part for one or more of the article's ingredients.
SUBSTITUTE refusals by year
| Year | Refusals | YoY | |
|---|---|---|---|
| 2020 | 1 | — | |
| 2021 | 7 | +600.0% | |
| 2022 | 11 | +57.1% | |
| 2023 | 7 | -36.4% | |
| 2024 | 5 | -28.6% | |
| 2025 | 5 | +0.0% | |
| 2026 | 5 | — | YTD |
| Total | 41 |
Origins most often refused under SUBSTITUTE
| # | Origin country | Refusals |
|---|---|---|
| 1 | Mexico | 8 |
| 2 | India | 5 |
| 3 | Italy | 4 |
| 4 | Spain | 4 |
| 5 | Yemen | 4 |
| 6 | Armenia | 3 |
| 7 | Dominican Republic | 3 |
| 8 | Vietnam | 3 |
| 9 | Taiwan | 2 |
| 10 | Chile | 1 |
| 11 | Lebanon | 1 |
| 12 | Philippines | 1 |
| 13 | Thailand | 1 |
| 14 | Turkey | 1 |
Product categories refused under SUBSTITUTE
| # | Product category | Refusals |
|---|---|---|
| 1 | Food Sweeteners (Nutritive) | 25 |
| 2 | Fruit and Fruit Products | 10 |
| 3 | Spices, Flavors, and Salts | 4 |
| 4 | Color Additives for Foods, Drugs, and Cosmetics | 1 |
| 5 | Milk, Butter, and Dried Milk Products | 1 |
Latest refusals citing SUBSTITUTE
- EJ2-0200254-2 HONEYFrom Armenia, Food Sweeteners (Nutritive). substitution
- 8MH-0110897-2 IMITATION SYRUPS, MOLASSES AND HONEY, N.E.C.From Mexico, Food Sweeteners (Nutritive). substitution
- H87-0299593-2 SYRUPS AND MOLASSES, N.E.C.From Mexico, Food Sweeteners (Nutritive). label not conspicuoussubstitutionnutrition labeling
- BQL-0111989-8 HONEYFrom Armenia, Food Sweeteners (Nutritive). substitution
- 224-3646960-9 HONEYFrom Armenia, Food Sweeteners (Nutritive). substitution
- KM6-3654846-3 BUTTER OILFrom India, Milk, Butter, and Dried Milk Products. false or misleading labelsubstitution
- H87-0294856-8 HONEYFrom Mexico, Food Sweeteners (Nutritive). substitution
- DR4-0636640-8 HONEYFrom Mexico, Food Sweeteners (Nutritive). label not conspicuousfalse or misleading labelsubstitutionnutrition labeling
- BDD-0882488-6 SAFFRON, WHOLE (SPICE)From Philippines, Spices, Flavors, and Salts. substitutioncolor not declaredFD&C Yellow No. 5 undeclared
- AY0-0132257-9 LEMON, CITRUS FRUIT JUICES OR CONCENTRATESFrom Taiwan, Fruit and Fruit Products. substitution
- W24-1401498-5 HONEYFrom Yemen, Food Sweeteners (Nutritive). substitution
- BNI-0124940-6 SAFFRON, GROUND, CRACKED (SPICE)From Spain, Spices, Flavors, and Salts. substitutionrequired information omitted
- 9LN-2046551-4 HONEYFrom Mexico, Food Sweeteners (Nutritive). substitution
- EVR-0133523-6 LEMON, CITRUS FRUIT JUICES OR CONCENTRATESFrom Taiwan, Fruit and Fruit Products. substitutionno net quantity
- 417-0381599-7 LEMON, CITRUS FRUIT JUICES OR CONCENTRATESFrom Turkey, Fruit and Fruit Products. substitution
- KM6-3606587-2 LEMON, CITRUS FRUIT JUICES OR CONCENTRATESFrom India, Fruit and Fruit Products. false or misleading labelsubstitution
- 316-2067278-7 LEMON, CITRUS FRUIT JUICES OR CONCENTRATESFrom India, Fruit and Fruit Products. substitutionjuice percentage not declarednutrition labeling
- DF4-1602112-2 HONEYFrom Italy, Food Sweeteners (Nutritive). substitutionbulking agent added
- 224-4266895-4 LEMON, CITRUS FRUIT JUICES OR CONCENTRATESFrom Italy, Fruit and Fruit Products. substitution
- 224-4266763-4 LEMON, CITRUS FRUIT JUICES OR CONCENTRATESFrom Italy, Fruit and Fruit Products. substitution
About SUBSTITUTE
What does the FDA import refusal charge SUBSTITUTE mean?
FDA uses SUBSTITUTE for: substitution. Its published charge language reads: “The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients.”
Is SUBSTITUTE a food safety finding?
SUBSTITUTE is in none of this site's charge groups, so this site does not class it as a hazard finding. Under the rule used everywhere on the site, a refusal citing it and no hazard charge is counted with paperwork. Read FDA's charge language above for what it covers.
What happens to a shipment refused under SUBSTITUTE?
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.