Import Alert 54-12

Import Alert # 54-12

Published Date: 05/02/2025

Type: DWPE with Surveillance

***"DETENTION WITHOUT PHYSICAL EXAMINATION OF FOODS CONTAINING GINSENG THAT FAIL TO PROPERLY DECLARE GINSENG"***

NOTE: The revision to this Import Alert dated 01/31/2025 updates the title of the import alert, the Guidance section to include removal from DWPE information and current contacts, the PAF and PAC sections. Changes are noted and bracketed by asterisks (***).

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.”

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."

*** Divisions may detain, without physical examination (DWPE), the identified products from the firms on the Red List of this Import Alert, or if it otherwise appears that the food purports to be or is represented as “ginseng” (e.g., "Siberian ginseng"), but is not an herb or herbal ingredient derived from the botanical genus Panax.

The misbranding provision regarding the term "ginseng" for foods that are not or do not contain an herb or herbal ingredient derived from the botanical genus Panax applies to labeling. Examples of labeling include a statement of identity, nutrition/supplement facts labeling, ingredient listing, and general statements on the label or labeling. Please note that labeling examinations should be conducted on both bulk and retail products.

***Recommendations for DWPE addition to Red List require documentation of Center/Program concurrence, when the action is not covered by direct reference authority (DRA). Final recommendations for DWPE additions to Red List should be forwarded to the Division of Import Operations (DIO). ***

Release of Articles Subject to Detention Without Physical Examination under This Import alert:

In order to secure release of an individual shipment subject to detention without physical examination under this import alert, the owner, consignee and/or another responsible party to the shipment should provide information showing that the product is not misbranded under section 403(u) of the FD&C Act. Such information may include documentation supplied in English which shows the term “ginseng” is being used to represent herbs or herbal ingredients that are derived from a plant classified within the genus Panax in accordance with section 403(u) of the FD&C Act.

The following lists the standardized names for the following Eleutherococcus senticosus and Panax spp. botanical ingredients in dietary supplements (see 21 CFR 101.4(h)):

Latin Binomial Common Name
Eleutherococcus senticosus Eleuthero
Panax ginseng Asian ginseng
Panax pseudoginseng var. japonica Japanese ginseng
Panax pseudoginseng var. notoginseng Tienchi ginseng
Panax quinquefolius American ginseng

Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):

In order to remove a firm’s product from the Red List of this Import Alert, information should be provided to the Agency to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance
of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the FD&C Act.

For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)" or at FDA.gov/ Removal from Import Alert - https://www.fda.gov/industry/import-alerts/removal-import-alert

If a firm and/or a representative thereof would like to submit a petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov

Questions or issues involving import operations or the submissions of petitions for removal from DWPE should be addressed to OII/DIO (301) 796-0356 or Imports@fda.hhs.gov.

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed FDAPRIVATELABIMPORTALERTS@fda.hhs.gov

Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov

                                                                                                                                                           ***

Foods labeled as being or containing "ginseng"

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because it or its ingredients purport to be or are represented as Ginseng but are not an herb or herbal ingredient derived from a plant classified within the genus Panax [Misbranded, Section 403(u)]."


OASIS CHARGE CODE: SBGINSENG

Desc: AmaZing Powder Concentrate

Desc: AmaZing Powder Concentrate

Desc: AmaZing Powder Concentrate

Desc: Body Brilliance

Notes: (Name and address on product label) Bodyism Global Ltd. Bulgari Hotel & Residence 171 Knightsbridge SW7 IDW United Kingdom FEI; None ;Problem(s); Siberian Ginseng

Desc: BASE DAILY GREENS SUMMER PINEAPPLE Dietary Supplement

Desc: BASE DAILY GREENS CHERRIES JUBILEE Dietary Supplement

Desc: BASE DAILY GREENS HIBISCUS GRAPE Dietary Supplement

Desc: PhD Pharma-Greens Lemon Lime Diet Supplement

Desc: PhD Pharma-Greens Unflavoured Diet Supplement

Desc: PhD Pharma-Greens Unflavoured Diet Supplement

Desc: PhD Pharma-Greens Lemon Lime Diet Supplement

Desc: PhD Pharma-Greens Lemon Lime Diet Supplement

Desc: PhD Pharma-Greens Unflavoured Diet Supplement

Desc: BASE DAILY GREENS CHERRIES JUBILEE Dietary Supplement

Desc: BASE DAILY GREENS SUMMER PINEAPPLE Dietary Supplement

Desc: BASE DAILY GREENS HIBISCUS GRAPE Dietary Supplement

Desc: SIBERIAN GINSENG EXTRACT

Desc: SIBERIAN GINSENG EXTRACT

Desc: S.G1 Siberian Ginseng Capsules

Desc: S.G1 Siberian Ginseng Capsules

Desc: S.G1 Siberian Ginseng Capsules

Desc: S.G1 Siberian Ginseng Capsules

Desc: Ginseng "HONEY PLUS HERBAL MIX PASTE"

Desc: Ginseng "HONEY PLUS HERBAL MIX PASTE"