FDA refusal charge DIRSEXMPT: no adequate directions
← All charge codes Labelling Dashboard
The DIRSEXMPT charge appeared in 88 FDA import refusals between 2020 and 2026 — 0.3% of all 26,358 US import refusals. The charge is a labelling or registration failure, not a hazard found in the product. The origins cited most often are Canada, China, India. The most-affected product category is Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. Volume in 2025 was down 53% on 2024.
Email me about new FDA import refusals involving the DIRSEXMPT charge
One email a week, and only when something matches. We'll send a confirmation link first; unsubscribe any time from the footer of any email.
What FDA's charge says
DIRSEXMPT 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 to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
DIRSEXMPT refusals by year
| Year | Refusals | YoY | |
|---|---|---|---|
| 2020 | 18 | — | |
| 2021 | 18 | +0.0% | |
| 2022 | 6 | -66.7% | |
| 2023 | 19 | +216.7% | |
| 2024 | 15 | -21.1% | |
| 2025 | 7 | -53.3% | |
| 2026 | 5 | — | YTD |
| Total | 88 |
Origins most often refused under DIRSEXMPT
| # | Origin country | Refusals |
|---|---|---|
| 1 | Canada | 10 |
| 2 | China | 10 |
| 3 | India | 10 |
| 4 | United Kingdom | 8 |
| 5 | Malaysia | 6 |
| 6 | Mexico | 4 |
| 7 | Indonesia | 3 |
| 8 | Ivory Coast | 3 |
| 9 | Japan | 3 |
| 10 | Thailand | 3 |
| 11 | United States | 3 |
| 12 | Nigeria | 2 |
| 13 | South Africa | 2 |
| 14 | South Korea | 2 |
| 15 | Taiwan | 2 |
| 16 | Turkey | 2 |
| 17 | United Arab Emirates | 2 |
| 18 | Australia | 1 |
| 19 | Colombia | 1 |
| 20 | Cyprus | 1 |
| 21 | Guyana | 1 |
| 22 | Hong Kong | 1 |
| 23 | Israel | 1 |
| 24 | Italy | 1 |
| 25 | Moldova | 1 |
| 26 | Philippines | 1 |
| 27 | Portugal | 1 |
| 28 | Russia | 1 |
| 29 | Saint Lucia | 1 |
| 30 | Ukraine | 1 |
Product categories refused under DIRSEXMPT
| # | Product category | Refusals |
|---|---|---|
| 1 | Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans | 78 |
| 2 | Candy Without Chocolate, Candy Specialties, and Chewing Gum | 2 |
| 3 | Whole Grains, Milled Grain Products, and Starch | 2 |
| 4 | Chocolate and Cocoa Products | 1 |
| 5 | Coffee and Tea | 1 |
| 6 | Food Sweeteners (Nutritive) | 1 |
| 7 | Ice Cream and Related Products | 1 |
| 8 | Soft Drinks and Waters | 1 |
| 9 | Spices, Flavors, and Salts | 1 |
Latest refusals citing DIRSEXMPT
- W69-5216310-4 HERBALS & BOTANICALS (NOT TEAS), N.E.C.From China, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no adequate directionsunsafe food additivepoisonous or deleterious substanceunapproved new drug
- EQN-0048610-3 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From South Africa, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. establishment not listedno adequate directionsforeign plant not registeredunapproved animal drug+2 more
- 8VH-2600085-4 VERVAIN (HERBAL & BOTANICALS, NOT TEAS)From Saint Lucia, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no adequate directionssupplement labelingplant part not declarednutrition labeling+1 more
- 9DH-0080514-8 PSYLLIUM (FIBER)From Canada, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. establishment not listedno adequate directionsforeign plant not registeredlabeling
- J21-0116965-9 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From United Kingdom, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingfalse or misleading labelno contact informationnutrition labeling+8 more
- BQL-0107961-3 HERBALS & BOTANICALS (NOT TEAS), N.E.C.From Moldova, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no adequate directionsnutrition labelingunapproved new drug
- 799-8484924-1 ALOE (HERBAL AND BOTANICAL (NOT TEAS) II (CONTINUED))From Israel, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. ingredients not listedno adequate directions
- 799-8801492-5 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Hong Kong, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. ingredients not listedno adequate directionssupplement labelingno manufacturer name+2 more
- SCS-0244471-4 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Canada, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no adequate directionsnew dietary ingredient
- EPW-0026220-8 HERBALS & BOTANICALS (NOT TEAS), N.E.C.From Canada, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no adequate directionsunapproved new drug
- SCS-0245881-3 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Canada, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no adequate directionsnew dietary ingredient
- SCS-8620830-7 KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED)From Thailand, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no adequate directionslabel not conspicuousno manufacturer namenew dietary ingredient+1 more
- AEK-5782049-8 BARLEY, WHOLE GRAINFrom Philippines, Whole Grains, Milled Grain Products, and Starch. no adequate directionsnutrition labelingunapproved new drug
- 799-3867757-3 GLUCOSAMINE HYDROCHLORIDE (HERBAL AND BOTANICALS, NOT TEAS II)From United States, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no adequate directionsnot in English
- AEK-5789917-9 VIT DFrom China, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no adequate directions
- 9AJ-0862553-3 MILLED GRAIN PRODUCTS, N.E.C.From India, Whole Grains, Milled Grain Products, and Starch. establishment not listedno adequate directionsforeign plant not registeredunapproved new drug+6 more
- BNI-0127704-3 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From South Africa, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. establishment not listedno adequate directionsforeign plant not registeredunapproved new drug
- 9RN-1212520-6 ARISTOLOCHIA (FANGCHI), (HERBAL & BOTANICALS, NOT TEA)From Nigeria, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. establishment not listedingredients not listedno adequate directionsno net quantity+4 more
- N5Q-2400443-0 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From United States, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no adequate directionsunapproved new drug
- 300-4871427-5 CHOCOLATE CANDY BAR, WITH NUTS AND FRUITFrom Canada, Chocolate and Cocoa Products. ingredients not listedno adequate directionsunapproved new drugunsafe food additive
About DIRSEXMPT
What does the FDA import refusal charge DIRSEXMPT mean?
FDA uses DIRSEXMPT for: no adequate directions. Its published charge language 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.”
Is DIRSEXMPT a food safety finding?
No. DIRSEXMPT is a labelling or registration failure: the charge is about the label, the filing or the paperwork, not a hazard found in the product. A refusal citing it alone is counted as paperwork on this site.
What happens to a shipment refused under DIRSEXMPT?
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.