FDA refusal charge
FDA refusal charge UNSFDIETSP
Dietary ingredient without safety assurance
UNSFDIETSP is the FDA import refusal charge for dietary ingredient without safety assurance; it cites sections 402(f)(1)(B) and 801(a)(3) Adulteration of the FD&C Act. FDA recorded it on 1,109 refused shipment lines between October 2016 and September 8, 2026, most often for dietary supplements from Indonesia.
Data from FDA public records, last checked .
- 1,109
- refused shipment lines carry this charge
- 23
- countries of origin
- 1
- import alert names this charge
What UNSFDIETSP means
The product appeared to be a dietary supplement or dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury.
This restates FDA's statement. It says what the charge means, never why a particular shipment was refused.
- FD&C Act section
- 402(f)(1)(B)801(a)(3) Adulteration
FDA's official statement
Copied unchanged from FDA's Refusal Charges reference table.
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
Import alerts that name UNSFDIETSP
The charge section of each alert names this code. An alert lists firms; a charge is the reason recorded on one refused line.
| Alert | Covers | Red | Green |
|---|---|---|---|
| 54-15 | Supplements and ingredients containing kratom | 58 |
Countries with the most UNSFDIETSP refusals
Shipment lines carrying UNSFDIETSP, by country of origin.
| Country | Lines | Share of UNSFDIETSP |
|---|---|---|
| Indonesia | 852 | 77% |
| Singapore | 107 | 10% |
| India | 37 | 3% |
| United Kingdom | 21 | 2% |
| China | 18 | 2% |
| Canada | 17 | 2% |
| Netherlands | 15 | 1% |
| Lithuania | 10 | 1% |
| Hong Kong | 8 | 1% |
| United Arab Emirates | 4 | 0% |
Product categories with the most UNSFDIETSP refusals
| Category | Lines | Share of UNSFDIETSP |
|---|---|---|
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 1,075 | 97% |
| Coffee and Tea | 23 | 2% |
| Color Additives for Foods, Drugs, and Cosmetics | 5 | 0% |
| Dietary Conventional Foods and Meal Replacements | 4 | 0% |
| Nuts and Edible Seeds | 1 | 0% |
| Spices, Flavors, and Salts | 1 | 0% |
Latest UNSFDIETSP refusals
The 20 most recent refused lines, through September 8, 2026, each with its FDA source.
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| PT. Raw Botanical NusantaraKota Semarang, Indonesia | Kratom (herbal and botanical teas ii, continued) | UNSFDIETSP | Source | |
| PT Bumindo Inti MakmurSidoarjo, Indonesia | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| BTSA, Biotecnologias AplicadasAlcala de Henares, Spain | Quinoa seed (edible seed) | UNSFDIETSPUNSAFE ADD | Source | |
| CV. Ihsan Jaya LogistikBarat, Indonesia | Herbals & botanical teas, n.e.c | UNSFDIETSPSTD IDENTLACKS FIRM | Source | |
| CV. Ihsan Jaya LogistikBarat, Indonesia | Herbals & botanical teas, n.e.c | UNSFDIETSPSTD IDENTLACKS FIRM | Source | |
| CV. Ihsan Jaya LogistikBarat, Indonesia | Herbals & botanical teas, n.e.c | UNSFDIETSPLACKS FIRM | Source | |
| Predator Nutrition Online LtdLeeds, United Kingdom | Dietary conventional foods, n.e.c | UNSFDIETSP | Source | |
| Predator Nutrition Online LtdLeeds, United Kingdom | Dietary conventional foods, n.e.c | UNSFDIETSP | Source | |
| Jeph India Food Pvt LtdJaipur, India | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| Jeph India Food Pvt LtdJaipur, India | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| PT. Aditama Sentosa IndonesiaMalang, Indonesia | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| Krishna Overseas Inc.New Delhi, India | Betel nut (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| Evolution Consulting Co., LtdWatthana, Thailand | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| PT Sahabat Sukses Kalimantan BaratKuburaya, Indonesia | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| Big Trea B VMaastricht, Netherlands | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| PT Sahabat Sukses Kalimantan BaratKuburaya, Indonesia | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| PT Sahabat Sukses Kalimantan BaratKuburaya, Indonesia | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| PT Sahabat Sukses Kalimantan BaratKuburaya, Indonesia | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| PT. Nirwadaya Indo LogistikJakarta, Indonesia | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| PT Transindo Antariksa BorneoPontianak, Indonesia | Kratom (herbal and botanical teas ii, continued) | UNSFDIETSP | Source |
Questions about UNSFDIETSP
- What does UNSFDIETSP mean on an FDA refusal?
- UNSFDIETSP is the refusal charge “Dietary ingredient without safety assurance”. The product appeared to be a dietary supplement or dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury.
- What law does UNSFDIETSP cite?
- FDA's refusal charge table cites sections 402(f)(1)(B) and 801(a)(3) Adulteration of the FD&C Act for UNSFDIETSP. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
- Which countries have the most UNSFDIETSP refusals?
- As of October 26, 2026, the countries with the most UNSFDIETSP refusal lines are Indonesia (852), Singapore (107) and India (37). The full list with links is in the table on this page.
- Is there an FDA import alert for UNSFDIETSP?
- Yes. One FDA import alert names UNSFDIETSP as a charge code, including Import Alert 54-15 (Supplements and ingredients containing kratom). An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.
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