FDA refusal charge
FDA refusal charge SUBSTITUTE
SUBSTITUTE is the FDA import refusal charge for appears that a substance has been substituted wholly or in part for one or more of the article's ingredients.; it cites sections 402(b)(2) and 801(a)(3) of the FD&C Act (adulteration). FDA recorded it on 56 refused shipment lines between October 2016 and May 18, 2026, most often for sweeteners from Mexico.
Data from FDA public records, last checked .
- 56
- refused shipment lines carry this charge
- 14
- countries of origin
- 1
- import alert names this charge
What SUBSTITUTE means
SupplierRadar has not written a plain-English version of SUBSTITUTE yet. FDA's own statement is quoted below.
- FD&C Act section
- 402(b)(2)801(a)(3)
- Classification
- adulteration
FDA's official statement
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.
Import alerts that name SUBSTITUTE
| Alert | Covers | Red | Green |
|---|---|---|---|
| 99-47 | Foods that appear adulterated for economic gain | 52 |
Countries with the most SUBSTITUTE refusals
Product categories with the most SUBSTITUTE refusals
| Category | Lines | Share of SUBSTITUTE |
|---|---|---|
| Food Sweeteners (Nutritive) | 38 | 68% |
| Fruit and Fruit Products (berries, citrus and core fruits) | 9 | 16% |
| Spices, Flavors, and Salts | 5 | 9% |
| Milk, Butter, and Dried Milk Products | 1 | 2% |
| Fruit and Fruit Products (pit, subtropical and tropical fruits) | 1 | 2% |
| Fruit and Fruit Products (vine and other fruits) | 1 | 2% |
| Color Additives for Foods, Drugs, and Cosmetics | 1 | 2% |
Latest SUBSTITUTE refusals
Questions about SUBSTITUTE
- What does SUBSTITUTE mean on an FDA refusal?
- SUBSTITUTE is the refusal charge “Appears that a substance has been substituted wholly or in part for one or more of the article's ingredients.”. FDA's official statement for the charge 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.”
- What law does SUBSTITUTE cite?
- FDA's refusal charge table cites sections 402(b)(2) and 801(a)(3) of the FD&C Act (adulteration) for SUBSTITUTE, 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 SUBSTITUTE refusals?
- As of October 25, 2026, the countries with the most SUBSTITUTE refusal lines are Mexico (14), Spain (7) and India (6). The full list with links is in the table on this page.
- Is there an FDA import alert for SUBSTITUTE?
- Yes. One FDA import alert names SUBSTITUTE as a charge code, including Import Alert 99-47 (Foods that appear adulterated for economic gain). An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.
Built for the person who signs the FSVP file
Look before you order.
Check up to five suppliers against every FDA record in one paste, no account needed. Watch the ones you buy from and get the source the day a record changes.
SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.