FDA refusal charge
FDA refusal charge UNAPPROVED
Unapproved new drug
UNAPPROVED is the FDA import refusal charge for unapproved new drug; it cites sections 505(a) and 801(a)(3) of the FD&C Act (unapproved new drug). FDA recorded it on 5,203 refused shipment lines between October 2016 and October 9, 2026, most often for dietary supplements from India.
Data from FDA public records, last checked .
- 5,203
- refused shipment lines carry this charge
- 93
- countries of origin
- 2
- import alerts name this charge
What UNAPPROVED means
The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.
This restates FDA's statement. It says what the charge means, never why a particular shipment was refused.
- FD&C Act section
- 505(a)801(a)(3)
- Classification
- unapproved new drug
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 new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Import alerts that name UNAPPROVED
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 UNAPPROVED refusals
Shipment lines carrying UNAPPROVED, by country of origin.
Product categories with the most UNAPPROVED refusals
| Category | Lines | Share of UNAPPROVED |
|---|---|---|
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 4,230 | 81% |
| Dietary Conventional Foods and Meal Replacements | 542 | 10% |
| Soft Drinks and Waters | 159 | 3% |
| Coffee and Tea | 69 | 1% |
| Food Sweeteners (Nutritive) | 45 | 1% |
| Spices, Flavors, and Salts | 37 | 1% |
| Fruit and Fruit Products (pit, subtropical and tropical fruits) | 25 | 0% |
| Milk, Butter, and Dried Milk Products | 16 | 0% |
| Candy without Chocolate, Candy Specialties, and Chewing Gum | 15 | 0% |
| Whole Grains, Milled Grain Products, and Starch | 7 | 0% |
Latest UNAPPROVED refusals
The 20 most recent refused lines, through October 9, 2026, each with its FDA source.
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Hawa SannohBushrod Island, Liberia | Citrus aurantium ( herbal & botanical other than teas) | UNAPPROVED | Source | |
| Froximun AgSchlanstedt, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| SelectepharmaMixco, Guatemala | Mecobalamin (vitamin) | UNAPPROVED | Source | |
| Himalaya Wellness CompKora Hobli Tumakuru, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| SBL Private LimitedEast Delhi, India | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Winnexa Health Science Pvt LtdIndore, India | Probiotics (vit/min/protein/unconventional dietary spec for human/animal, n.e.c.) | UNAPPROVED | Source | |
| MercNaucalpan De Juarez, Mexico | Vitamin b6 (pyridoxine) | UNAPPROVED | Source | |
| Harisre AyurvedicsPanthalloor, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Harisre AyurvedicsPanthalloor, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Harisre AyurvedicsPanthalloor, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Viatris Pharma SRLMilan, Italy | Vitamin d2 (calciferol) | UNAPPROVED | Source | |
| Everest AyurvedaKerala, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Cinnamon, cassia, ground, cracked (spice) | UNAPPROVED | Source | |
| Vaidyaratnam Oushadhasala Pvt LtdThrissur, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Harisre AyurvedicsPanthalloor, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Cinnamon, cassia, ground, cracked (spice) | UNAPPROVED | Source | |
| Aimil Pharmaceuticals IndiaNew Delhi, India | Cocculus | UNAPPROVED | Source | |
| Bayer de Mexico, S.A. de C.V.Lerma, Mexico | Vitamin c (ascorbic acid) | UNAPPROVED | Source | |
| Sheth BrothersBhavnagar, India | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source |
Questions about UNAPPROVED
- What does UNAPPROVED mean on an FDA refusal?
- UNAPPROVED is the refusal charge “Unapproved new drug”. The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.
- What law does UNAPPROVED cite?
- FDA's refusal charge table cites sections 505(a) and 801(a)(3) of the FD&C Act (unapproved new drug) for UNAPPROVED, and classifies the charge as unapproved new drug. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
- Which countries have the most UNAPPROVED refusals?
- As of October 26, 2026, the countries with the most UNAPPROVED refusal lines are India (1,398), Mexico (1,271) and Malaysia (294). The full list with links is in the table on this page.
- Is there an FDA import alert for UNAPPROVED?
- Yes. 2 FDA import alerts name UNAPPROVED 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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