FDA refusal charge
FDA refusal charge DIRSEXMPT
Appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
DIRSEXMPT is the FDA import refusal charge for appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.; it cites sections 502(f)(1) and 801(a)(3) of the FD&C Act (misbranding). FDA recorded it on 173 refused shipment lines between October 2016 and August 5, 2026, most often for dietary supplements from China.
Data from FDA public records, last checked .
- 173
- refused shipment lines carry this charge
- 35
- countries of origin
- 0
- import alerts name this charge
What DIRSEXMPT means
SupplierRadar has not written a plain-English version of DIRSEXMPT yet. FDA's own statement is quoted below.
- FD&C Act section
- 502(f)(1)801(a)(3)
- Classification
- misbranding
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 be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Countries with the most DIRSEXMPT refusals
Shipment lines carrying DIRSEXMPT, by country of origin.
| Country | Lines | Share of DIRSEXMPT |
|---|---|---|
| China | 22 | 13% |
| India | 22 | 13% |
| Mexico | 21 | 12% |
| Canada | 17 | 10% |
| South Africa | 14 | 8% |
| Malaysia | 12 | 7% |
| United Kingdom | 11 | 6% |
| Cote d'Ivoire | 6 | 3% |
| Russia | 4 | 2% |
| Thailand | 4 | 2% |
Product categories with the most DIRSEXMPT refusals
| Category | Lines | Share of DIRSEXMPT |
|---|---|---|
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 147 | 85% |
| Food Sweeteners (Nutritive) | 11 | 6% |
| Soft Drinks and Waters | 3 | 2% |
| Coffee and Tea | 3 | 2% |
| Candy without Chocolate, Candy Specialties, and Chewing Gum | 3 | 2% |
| Milk, Butter, and Dried Milk Products | 2 | 1% |
| Whole Grains, Milled Grain Products, and Starch | 1 | 1% |
| Snack Food Items | 1 | 1% |
| Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables) | 1 | 1% |
| Dietary Conventional Foods and Meal Replacements | 1 | 1% |
Latest DIRSEXMPT refusals
The 20 most recent refused lines, through August 5, 2026, each with its FDA source.
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTVETDRUGRES+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRSEXMPTVET DR LBLNEW VET DR | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRSEXMPTVETDRUGRESVET DR LBL | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRSEXMPTVET DR LBLNEW VET DR | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTFRNMFGREG+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRSEXMPTVET DR LBLNEW VET DR | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTVETDRUGRES+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRSEXMPTVET DR LBLNEW VET DR | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTFRNMFGREG+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTFRNMFGREG+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTFRNMFGREG+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRSEXMPTVETDRUGRESVET DR LBL | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTFRNMFGREG+1 | Source | |
| Mount Kailash Rejuvenation Centre Inc.Castries, Saint Lucia | Damiana (herbal & botanicals, not teas) | DIRSEXMPTDIETARYINGPLANT PART+1 | Source | |
| Mount Kailash Rejuvenation Centre Inc.Castries, Saint Lucia | Vervain (herbal & botanicals, not teas) | DIRSEXMPTDIETARYLBLPLANT PART+1 | Source | |
| Procter & GambleBelleville, Canada | Psyllium (fiber) | NOT LISTEDDIRSEXMPTFRNMFGREG+1 | Source | |
| Live Wellness LimitedGlasgow, United Kingdom | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRSEXMPTCOSMETLBLGUNAPPROVED | Source | |
| Farmacia ROMANITA-MIHAILOVCA, SRLMihailovca, Moldova | Herbals & botanicals (not teas), n.e.c | DIRSEXMPTNUTRIT LBLUNAPPROVED | Source | |
| E.M.B Yarden Agricultural Farm LtdBeit Shemesh, Israel | Aloe (herbal and botanical (not teas) ii (continued)) | LIST INGREDIRSEXMPT | Source | |
| Infinity Life Trading Co LtdCheung Sha Wan, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LIST INGREDIRSEXMPTDIETARYLBL+3 | Source |
Questions about DIRSEXMPT
- What does DIRSEXMPT mean on an FDA refusal?
- DIRSEXMPT is the refusal charge “Appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.”. 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 be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.”
- What law does DIRSEXMPT cite?
- FDA's refusal charge table cites sections 502(f)(1) and 801(a)(3) of the FD&C Act (misbranding) for DIRSEXMPT, 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 DIRSEXMPT refusals?
- As of October 25, 2026, the countries with the most DIRSEXMPT refusal lines are China (22), India (22) and Mexico (21). The full list with links is in the table on this page.
- Is there an FDA import alert for DIRSEXMPT?
- SupplierRadar found no food import alert whose charge section names DIRSEXMPT. An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.
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