FDA refusal charge
FDA refusal charge BIO TOXIN
BIO TOXIN is the FDA import refusal charge for appears to contain a poisonous and deleterious substance which would ordinarily render it injurious to…; it cites sections 402(a)(1) and 801(a)(3), Adulteration of the FD&C Act. FDA recorded it on 6 refused shipment lines from 1 country between October 2016 and July 25, 2022, most often for dietary supplements from India.
Data from FDA public records, last checked .
- 6
- refused shipment lines carry this charge
- 1
- countries of origin
- 0
- import alerts name this charge
What BIO TOXIN means
SupplierRadar has not written a plain-English version of BIO TOXIN yet. FDA's own statement is quoted below.
- FD&C Act section
- 402(a)(1)801(a)(3), Adulteration
FDA's official statement
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous and deleterious substance which would ordinarily render it injurious to health. Appears to contain
Countries with the most BIO TOXIN refusals
| Country | Lines | Share of BIO TOXIN |
|---|---|---|
| India | 6 | 100% |
Product categories with the most BIO TOXIN refusals
| Category | Lines | Share of BIO TOXIN |
|---|---|---|
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 6 | 100% |
Latest BIO TOXIN refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Marudhar ImpexAhmedabad, India | Ashwagandha (herbal & botanicals, not teas) | BIO TOXIN | Source | |
| Marudhar ImpexAhmedabad, India | Ashwagandha (herbal & botanicals, not teas) | BIO TOXIN | Source | |
| Marudhar ImpexAhmedabad, India | Ashwagandha (herbal & botanicals, not teas) | BIO TOXIN | Source | |
| Marudhar ImpexAhmedabad, India | Ashwagandha (herbal & botanicals, not teas) | BIO TOXIN | Source | |
| Marudhar ImpexAhmedabad, India | Ashwagandha (herbal & botanicals, not teas) | BIO TOXIN | Source | |
| Marudhar ImpexAhmedabad, India | Ashwagandha (herbal & botanicals, not teas) | BIO TOXIN | Source |
Questions about BIO TOXIN
- What does BIO TOXIN mean on an FDA refusal?
- BIO TOXIN is the refusal charge “Appears to contain a poisonous and deleterious substance which would ordinarily render it injurious to…”. 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 to contain a poisonous and deleterious substance which would ordinarily render it injurious to health. Appears to contain”
- What law does BIO TOXIN cite?
- FDA's refusal charge table cites sections 402(a)(1) and 801(a)(3), Adulteration of the FD&C Act for BIO TOXIN. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
- Which countries have the most BIO TOXIN refusals?
- As of October 26, 2026, the countries with the most BIO TOXIN refusal lines are India (6). The full list with links is in the table on this page.
- Is there an FDA import alert for BIO TOXIN?
- SupplierRadar found no food import alert whose charge section names BIO TOXIN. 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.