Import Alert 45-06: Detention without physical examination of stevia leaves, crude extracts of stevia leaves and foods containing stevia leaves and/or stevia extracts
As of October 25, 2026, FDA Import Alert 45-06 (Stevia leaves, crude extracts and foods containing them) lists 21 firms on its red list in 8 countries, covering stevia leaves and foods containing stevia leaves; 3 firms were added and 0 removed in the last 90 days.
Data from FDA public records, last checked . Request a correction
- 21
- firms on the red list
- 8
- countries
- 3
- added in the last 90 days
- 0
- removed in the last 90 days
What changed in the last 90 days
Removed from Import Alert 45-06
SupplierRadar has recorded no removals from Import Alert 45-06 in the last 90 days, as of October 25, 2026. A removal is shown at the top of this page, and on the firm's own page, the day it is found.
Added to Import Alert 45-06
| Firm | Country | List | Date published |
|---|---|---|---|
| Hefei Yili Dairy Co., LtdHefei, China | China | Red | |
| Jinzhong Yili Dairy Co., Ltd.Jinzhong, China | China | Red | |
| Qingdao Honghongyuan Health Industry Technology Co., LtdQingdao, China | China | Red |
Firms on Import Alert 45-06, by country
Listings by country
Japan (10)
FDA refusals from Japan| Firm | List | Products | Date published |
|---|---|---|---|
| JA BEVERAGE SAGA Co.,Ltd.Shimotsuke | Red | Alfalfa drink (Kanto Plant) | |
| Kuroda ShokuhinKobe | Red | Pickled Radish | |
| Miyazaki Nosan Co., Ltd.Koyu-Gun | Red | Pickled Radish | |
| Nagayama Foods Factory Co.,Ltd.Fukuoka | Red | Pickled Cucumber (Aokappaduke); Pickled Vegetable (Fukujinduke)/(Shibaduke); Pickled Radish /(Kizami Tsuboduke) | |
| Nozaki Tsukemono Co LtdMiyazaki | Red | Pickled Radish/ Amakuchi Katsuo Takuan Yagurashibori Konbu; salted radish; White Radish (Root & Tuber Vegetable), Cultur | |
| Sanko Co.,LtdAGEO-SHI | Red | Pickled Eggplant (Shiba Nasu); Pickled Cucumber (Shiso Kyuri)/(Akashiba Ippon) | |
| Shinshin Co. Ltd.Tokyo | Red | Chinese Radish (Daikon) (Root & Tuber Vegetable), Cultured/Cured; White Radish (Root & Tuber Vegetable), Cultured/Cured | |
| Yamaki Shokuhin Co.,Ltd.Niigata | Red | HITOKUCHIKIRI TAKUAN PICKLED RADISH BY SALT/Hitokuchi Ume Katsuo Takuan | |
| Yamasan Shokuhin KougyouImizu | Red | Pickled Radish (Tokyo Takuan)(Mini Half/Semi Half) | |
| Yamayoshi Shokuhin KogyoNerima | Red | Pickled Radish (Nerimanokaori Nerimatakuan)/White Radish (Root & Tuber Vegetable) |
China (4)
FDA refusals from China| Firm | List | Products | Date published |
|---|---|---|---|
| Hefei Yili Dairy Co., LtdHefei | Red | AMBPOEIAL (Ambrosial) Greek Style Drinking Yogurt Strawberry Flavor | |
| Jinzhong Yili Dairy Co., Ltd.Jinzhong | Red | AMBPOEIAL (Ambrosial) Greek Style Drinking Yogurt Strawberry Flavor | |
| Nutrakey Industries Inc.Qingdao | Red | Stevia Extract Powder | |
| Qingdao Honghongyuan Health Industry Technology Co., LtdQingdao | Red | All Glucosylated Steviol Glycoside (GSG) 80 Products, Including GSG 80 PCT, GSG 80 PCT EX, TAPIOCA, GSG 80PCT FEMA NGP, |
Canada (2)
FDA refusals from Canada| Firm | List | Products | Date published |
|---|---|---|---|
| Laboratoire ManuvesPointe-claire | Red | Fenugreek (Herbal & Botanicals, not Teas); Anti-Diabetic N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liqui | |
| PharmavigorMontreal | Red | Fenugreek (Herbal & Botanicals, not Teas); Anti-Diabetic N.E.C., Human - Non/Rx Combination Ingredient, NonSterile Liqui |
Brazil (1)
FDA refusals from Brazil| Firm | List | Products | Date published |
|---|---|---|---|
| Natural Corporation do Brazil Industria e Comercio LtdaSao Paulo | Red | Floranew (Natural fruit & vegetable conctrate) |
Colombia (1)
FDA refusals from Colombia| Firm | List | Products | Date published |
|---|---|---|---|
| Laboratorios Vidastevia LtdaBogota | Red | All Other Products, Non-Nutritive Sweeteners |
Mexico (1)
FDA refusals from Mexico| Firm | List | Products | Date published |
|---|---|---|---|
| Cafe del PacificoHermosillo | Red | De Leon Cafe Weight Loss Formula Cappuccino |
South Korea (1)
FDA refusals from South Korea| Firm | List | Products | Date published |
|---|---|---|---|
| Mammos Confectionery Co., Ltd. (aka Mammoth Confectionery)Seongnam-City | Red | Biscuits |
Vietnam (1)
FDA refusals from Vietnam| Firm | List | Products | Date published |
|---|---|---|---|
| Hoang Huy Development and Investment Trading Company LimitedHa Noi | Red | Toki slimming candy |
Refusal charges named on this alert
| Charge code | Meaning | Refusal lines since 2016 |
|---|---|---|
| UNSAFE ADD | Food additive unsafe under section 409 | 2,275 |
What the alert covers and why FDA issued it
- Official title
- Detention without Physical Examination of Stevia Leaves, Crude Extracts of Stevia Leaves and foods Containing Stevia Leaves and/or Stevia Extracts
- Product scope
- Stevia leaves and foods containing stevia leaves, UNLESS explicitly labeled as a dietary supplement or for use as a dietary ingredient of a dietary supplement; And Extracts obtained from stevia leaves and foods containing said extracts, UNLESS the stevia ingredient contains >= 95% steviol glycosides. (For purposes of this Alert, extracts that do not contain >= 95% steviol glycosides are referred to as "crude extracts.")
- Last published
The term stevia, as used in commerce, refers to the leaves of Stevia rebaudiana (Bertoni) Bertoni, a plant native to various parts of South America.
With regard to use in conventional foods, stevia leaf, or its crude extract, is not an approved food additive and is not considered GRAS due to inadequate toxicological information.
Read the rest of the reason
With regard to use in dietary supplements, dietary ingredients (including stevia) are not subject to food additive regulations.
Stevia leaf-derived products are approved for use as sweeteners in foods in Japan, Brazil, Australia, New Zealand, and other countries. Said products are used in a variety of foods, including teas, and are commonly used as table-top sweeteners.
Historically, stevia leaves and stevia leaf-derived products have been offered for entry both in bulk and in finished products such as teas, drinks, seafood, fruits, vegetables and candies.
Stevia leaves are known to contain high intensity sweetener compounds, which are collectively called steviol glycosides, and are approximately 200-300 times sweeter than sucrose. Steviol glycosides differ from stevia leaves in that they are purified extracts obtained from the leaves. Stevioside, rebaudioside A, rebaudioside D, rebaudioside M, enzyme-modified steviol glycosides, and other steviol glycosides for which FDA does not have questions following the review of a GRAS notification, individually or in combination, are the principal steviol glycosides used as sweeteners.
HFP/Office of Office of Premarket Additive Safety (OPMAS) responded to GRAS notices concerning highly purified steviol glycosides(>=95% steviol glycosides on a dried weight basis with stevioside, rebaudioside A, rebaudioside D, rebaudioside M, enzyme-modified steviol glycosides or other steviol glycosides as principal components), and determined these products are not subject to detention under this Import Alert (see #3 in Guidance Section for documentation required under this provision). Other steviol glycosides that may be present in these products as minor components of the >=95% total steviol glycosides content specified above include other rebaudiosides, dulcoside A, rubusoside, and steviolbioside.
It should be noted that steviol glycoside(s) may also be produced by fermentation technology without a need to use stevia leaves in the manufacturing process. In such cases, the import alert does not apply.
Listing on an import alert is FDA's notice to the firm and a fact an importer must consider in its supplier evaluation under 21 CFR 1.505. What the red, green and yellow lists mean.
Questions about Import Alert 45-06
- What is Import Alert 45-06?
- Import Alert 45-06, “Detention without physical examination of stevia leaves, crude extracts of stevia leaves and foods containing stevia leaves and/or stevia extracts”, is an FDA import alert. FDA may detain stevia leaves and foods containing stevia leaves from the firms on its red list without physical examination; FDA last published the alert on October 23, 2026.
- Which firms are on Import Alert 45-06?
- As of October 25, 2026, 21 firms are listed on Import Alert 45-06 in 8 countries; the most listings are in Japan (10), China (4) and Canada (2). The full table, grouped by country, is below on this page and every firm links to its record.
- How do firms get off Import Alert 45-06?
- A firm asks FDA to remove it by submitting evidence that the cause of the listing has been corrected. The Guidance section of the alert on FDA's website gives the procedure and the contact for 45-06; our guide explains the steps and the evidence FDA usually asks for.
- What charge does FDA use under Import Alert 45-06?
- The charge section of Import Alert 45-06 names UNSAFE ADD (food additive unsafe under section 409). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.
- Which firms were added to Import Alert 45-06 recently?
- As of October 25, 2026, 3 firms were added to Import Alert 45-06 in the last 90 days, including Hefei Yili Dairy Co., Ltd, Jinzhong Yili Dairy Co., Ltd. and Qingdao Honghongyuan Health Industry Technology Co., Ltd. The list with dates is below.
- Which firms were removed from Import Alert 45-06 recently?
- SupplierRadar has recorded no removals from Import Alert 45-06 in the last 90 days, as of October 25, 2026. A removal is shown at the top of this page and on the firm's page the day it is found.
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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.