FDA refusal charge
FDA refusal charge DIRECTIONS
Is a device whose label appears to not bear adequate directions for use.
DIRECTIONS is the FDA import refusal charge for is a device whose label appears to not bear adequate directions for use.; it cites sections 502(f)(1) and 801(a)(3) of the FD&C Act (misbranding). FDA recorded it on 297 refused shipment lines between October 2016 and March 28, 2024, most often for dietary supplements from Russia.
Data from FDA public records, last checked .
- 297
- refused shipment lines carry this charge
- 32
- countries of origin
- 2
- import alerts name this charge
What DIRECTIONS means
SupplierRadar has not written a plain-English version of DIRECTIONS 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 is a device whose label appears to not bear adequate directions for use.
Import alerts that name DIRECTIONS
The charge section of each alert names this code. An alert lists firms; a charge is the reason recorded on one refused line.
Countries with the most DIRECTIONS refusals
Shipment lines carrying DIRECTIONS, by country of origin.
| Country | Lines | Share of DIRECTIONS |
|---|---|---|
| Russia | 71 | 24% |
| Spain | 38 | 13% |
| China | 28 | 9% |
| Indonesia | 24 | 8% |
| India | 24 | 8% |
| Mexico | 14 | 5% |
| Netherlands | 14 | 5% |
| United Arab Emirates | 8 | 3% |
| Ghana | 8 | 3% |
| Bahamas | 7 | 2% |
Product categories with the most DIRECTIONS refusals
| Category | Lines | Share of DIRECTIONS |
|---|---|---|
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 269 | 91% |
| Fruit and Fruit Products (pit, subtropical and tropical fruits) | 8 | 3% |
| Food Sweeteners (Nutritive) | 5 | 2% |
| Dietary Conventional Foods and Meal Replacements | 5 | 2% |
| Beverage Bases | 3 | 1% |
| Vegetables and Vegetable Products (root and tuber vegetables, fungi) | 2 | 1% |
| Milk, Butter, and Dried Milk Products | 1 | 0% |
| Nuts and Edible Seeds | 1 | 0% |
| Spices, Flavors, and Salts | 1 | 0% |
| Candy without Chocolate, Candy Specialties, and Chewing Gum | 1 | 0% |
Latest DIRECTIONS refusals
The 20 most recent refused lines, through March 28, 2024, each with its FDA source.
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Jc Correa SasMedellin, Colombia | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRECTIONSUNAPPROVED | Source | |
| Dose Vital Manufacturing SDN BHDKuala Lumpur, Malaysia | Honey, n.e.c | DIRECTIONSUNSAFE ADDPOISONOUS+1 | Source | |
| PT. Angkutan Jasa AviasiPontianak, Indonesia | Kratom (herbal and botanicals, not teas ii) | NOT LISTEDDIRECTIONSFRNMFGREG | Source | |
| BTGIN Co., Ltd.Yuseong, South Korea | Ginseng, dried or paste (root & tuber vegetable) | DIRECTIONSUNAPPROVED | Source | |
| Plantas Medicinales de MexicoDELEGACION XOCHIMILCO C.P, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRECTIONSUNSAFE ADDPOISONOUS+1 | Source | |
| Plantas Medicinales de MexicoDELEGACION XOCHIMILCO C.P, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRECTIONSUNSAFE ADDPOISONOUS+1 | Source | |
| Plantas Medicinales de MexicoDELEGACION XOCHIMILCO C.P, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRECTIONSUNSAFE ADDPOISONOUS+1 | Source | |
| Carlos Alvear LopezJalmolonga Malinalco, Mexico | Gymnema sylvestre (herbal & botanicals, not teas) | DIRECTIONSUNAPPROVED | Source | |
| Carlos Alvear LopezJalmolonga Malinalco, Mexico | Gymnema sylvestre (herbal & botanicals, not teas) | DIRECTIONSUNAPPROVED | Source | |
| Carlos Alvear LopezJalmolonga Malinalco, Mexico | Citrus aurantium ( herbal & botanical other than teas) | DIRECTIONSUNAPPROVED | Source | |
| Carlos Alvear LopezJalmolonga Malinalco, Mexico | Citrus aurantium ( herbal & botanical other than teas) | DIRECTIONSUNAPPROVED | Source | |
| Kingdom Honey Sdn BhdKuala Lumpur, Malaysia | Honey | DIRECTIONSUNSAFE ADDPOISONOUS+1 | Source | |
| Eurocaps LimitedTredegar, United Kingdom | Herbals & botanicals (not teas), n.e.c | DIRECTIONSUNAPPROVED | Source | |
| Mubarek Dogal Urunler Gida San Ve Tic Ltd StiYenimahalle, Turkey | Honey | DIRECTIONSUNSAFE ADDPOISONOUS+1 | Source | |
| DoychPlovdiv, Bulgaria | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRECTIONSUNAPPROVED | Source | |
| Biopure EU Ltd.Guntramsdorf, Austria | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRECTIONSLIST INGREDIETARYLBL+6 | Source | |
| Biopure EU Ltd.Guntramsdorf, Austria | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRECTIONSLIST INGREDIETARYLBL+6 | Source | |
| Biopure EU Ltd.Guntramsdorf, Austria | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRECTIONSLIST INGREDIETARYLBL+6 | Source | |
| Biopure EU Ltd.Guntramsdorf, Austria | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIRECTIONSLIST INGREDIETARYLBL+6 | Source | |
| Karafi LimitedTakoradi, Ghana | Herbals & botanicals (not teas), n.e.c | DIRECTIONSUNAPPROVED | Source |
Questions about DIRECTIONS
- What does DIRECTIONS mean on an FDA refusal?
- DIRECTIONS is the refusal charge “Is a device whose label appears to not bear 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 is a device whose label appears to not bear adequate directions for use.”
- What law does DIRECTIONS cite?
- FDA's refusal charge table cites sections 502(f)(1) and 801(a)(3) of the FD&C Act (misbranding) for DIRECTIONS, 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 DIRECTIONS refusals?
- As of October 25, 2026, the countries with the most DIRECTIONS refusal lines are Russia (71), Spain (38) and China (28). The full list with links is in the table on this page.
- Is there an FDA import alert for DIRECTIONS?
- Yes. 2 FDA import alerts name DIRECTIONS as a charge code, including Import Alert 54-16 (Foods/supplements with active pharmaceutical ingredient) and Import Alert 54-10 (Bulk/finished dietary supplements products). 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.