FDA refusal charge
FDA refusal charge WARNINGS
WARNINGS is the FDA import refusal charge for it appears to lack adequate warning against use in a pathological condition or by children where it may be…; it cites sections 502(f)(2) and 801(a)(3) of the FD&C Act (misbranding). FDA recorded it on 2 refused shipment lines from 1 country between October 2016 and July 19, 2018, most often for dietary supplements from India.
Data from FDA public records, last checked .
- 2
- refused shipment lines carry this charge
- 1
- countries of origin
- 0
- import alerts name this charge
What WARNINGS means
SupplierRadar has not written a plain-English version of WARNINGS yet. FDA's own statement is quoted below.
- FD&C Act section
- 502(f)(2)801(a)(3)
- Classification
- misbranding
FDA's official statement
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
Countries with the most WARNINGS refusals
| Country | Lines | Share of WARNINGS |
|---|---|---|
| India | 2 | 100% |
Product categories with the most WARNINGS refusals
| Category | Lines | Share of WARNINGS |
|---|---|---|
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 2 | 100% |
Latest WARNINGS refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Organic Wellness Products Pvt LtNew Hyderabad, India | Herbals & botanicals (not teas), n.e.c | LIST INGREDIRSEXMPTLACKS FIRM+3 | Source | |
| Organic Wellness Products Pvt LtNew Hyderabad, India | Herbals & botanicals (not teas), n.e.c | LIST INGREDIRSEXMPTLACKS FIRM+3 | Source |
Questions about WARNINGS
- What does WARNINGS mean on an FDA refusal?
- WARNINGS is the refusal charge “It appears to lack adequate warning against use in a pathological condition or by children where it may be…”. FDA's official statement for the charge reads: “It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.”
- What law does WARNINGS cite?
- FDA's refusal charge table cites sections 502(f)(2) and 801(a)(3) of the FD&C Act (misbranding) for WARNINGS, and classifies the charge as misbranding. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
- Which countries have the most WARNINGS refusals?
- As of October 26, 2026, the countries with the most WARNINGS refusal lines are India (2). The full list with links is in the table on this page.
- Is there an FDA import alert for WARNINGS?
- SupplierRadar found no food import alert whose charge section names WARNINGS. An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.
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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.