Import Alert 54-12: Detention without physical examination of foods containing ginseng that fail to properly declare ginseng
As of October 26, 2026, FDA Import Alert 54-12 (Foods that do not properly declare ginseng) lists 9 firms on its red list in 5 countries, covering foods labeled as being or containing ginseng; 0 firms were added and 0 removed in the last 90 days.
Data from FDA public records, last checked . Request a correction
- 9
- firms on the red list
- 5
- countries
- 0
- added in the last 90 days
- 0
- removed in the last 90 days
What changed in the last 90 days
Removed from Import Alert 54-12
SupplierRadar has recorded no removals from Import Alert 54-12 in the last 90 days, as of October 26, 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 54-12
No firm was added to Import Alert 54-12 in the last 90 days, as of October 26, 2026.
Firms on Import Alert 54-12, by country
Listings by country
Canada (3)
FDA refusals from Canada| Firm | List | Products | Date published |
|---|---|---|---|
| 1965599 Ontario LtdWindsor | Red | Base daily greens summer pineapple dietary supplement; base daily greens cherries jubilee dietary supplement; base daily | |
| 7338457 Canada IncLangley | Red | PhD Pharma-Greens Lemon Lime Diet Supplement; PhD Pharma-Greens Unflavoured Diet Supplement; PhD Pharma-Greens Unflavour | |
| Canadian PremierWindsor | Red | Base daily greens cherries jubilee dietary supplement; base daily greens summer pineapple dietary supplement; base daily |
Australia (2)
FDA refusals from Australia| Firm | List | Products | Date published |
|---|---|---|---|
| A.G.M. Foods Pty LtdWynnum | Red | AmaZing Powder Concentrate | |
| Natural VitalityBrendale | Red | Body Brilliance |
China (2)
FDA refusals from China| Firm | List | Products | Date published |
|---|---|---|---|
| Hanzhong TRG Biotech Co., Ltd.Hanzhong | Red | Siberian ginseng extract | |
| Zhejiang Huisong Pharmaceutical Co., Ltd.Hangzhou | Red | Organic Siberian Ginseng Powder |
Israel (1)
FDA refusals from Israel| Firm | List | Products | Date published |
|---|---|---|---|
| Hekma Center Ltd.Ar'Ara | Red | S.G1 Siberian Ginseng Capsules |
Turkey (1)
FDA refusals from Turkey| Firm | List | Products | Date published |
|---|---|---|---|
| Naturals Bitkisel Urunler Remzi DurakDerince | Red | Ginseng honey plus herbal mix paste |
Refusal charges named on this alert
| Charge code | Meaning | Refusal lines since 2016 |
|---|---|---|
| SBGINSENG | Appears to be Misbranded because it or its ingredients purport to be or are represented as Ginseng, but are… | 47 |
What the alert covers and why FDA issued it
- Official title
- DETENTION WITHOUT PHYSICAL EXAMINATION OF FOODS CONTAINING GINSENG THAT FAIL TO PROPERLY DECLARE GINSENG
- Product scope
- Foods labeled as being or containing "ginseng"
- Last published
Section 10806(b)(1) of the Farm Security and Rural Investment Act of 2002 (the Farm Bill) (Pub.L.107-171), signed into law on May 13, 2002, by President Bush, provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax, and only labeling or advertising for herbs or herbal ingredients classified within that genus may include the term "ginseng." Section 10806(b)(2) amended section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 343) by adding the provision that a food is misbranded "if it purports to be or is represented as ginseng, unless it is an herb or herbal ingredient derived from a plant classified within the genus Panax." (Section 403(u) of the Act) (21 U.S.C. 343 (u)).
This amendment to the Act means that no food (including a dietary supplement as defined by Sections 201 (21 U.S.C. 321) (ff) of the Federal Food, Drug, and Cosmetic Act) may be represented as "ginseng" unless it is a botanical within the genus Panax. For example, many dietary supplements and their ingredients that are, or that contain, the botanical Eleutherococcus senticosus are often represented using the term "Siberian ginseng." Because plants within the genus Eleutherococcus are not the same genus as Panax, under 403(u) herbs or herbal ingredients derived from a plant classified within the genus Eleutherococcus cannot purport to be or be represented as ginseng ; under 403(u), only herbs or herbal ingredients classified within the Panax genus may purport to be or be represented as ginseng.
Read the rest of the reason
Accordingly, the term Siberian ginseng cannot be used to represent a food derived from dietary ingredient Eleutherococcus senticosus or a dietary supplement containing Eleutherococcus senticosus and not a plant classified within the genus Panax. Foods derived from Eleutherococcus senticosus may appropriately identify the ingredient using the Latin binomial Eleutherococcus senticosus or the common name "eleuthero."
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 54-12
- What is Import Alert 54-12?
- Import Alert 54-12, “Detention without physical examination of foods containing ginseng that fail to properly declare ginseng”, is an FDA import alert. FDA may detain foods labeled as being or containing ginseng from the firms on its red list without physical examination; FDA last published the alert on February 27, 2026.
- Which firms are on Import Alert 54-12?
- As of October 26, 2026, 9 firms are listed on Import Alert 54-12 in 5 countries; the most listings are in Canada (3), Australia (2) and China (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 54-12?
- 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 54-12; our guide explains the steps and the evidence FDA usually asks for.
- What charge does FDA use under Import Alert 54-12?
- The charge section of Import Alert 54-12 names SBGINSENG (appears to be Misbranded because it or its ingredients purport to be or are represented as Ginseng, but are…). 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 54-12 recently?
- No firm was added to Import Alert 54-12 in the last 90 days, as of October 26, 2026.
- Which firms were removed from Import Alert 54-12 recently?
- SupplierRadar has recorded no removals from Import Alert 54-12 in the last 90 days, as of October 26, 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.