IA #54-12, 5/7/04, IMPORT ALERT 54-12, "DETENTION WITHOUT PHYSICAL EXAMINATION
OF FOODS LABELED AS BEING OR CONTAINING "SIBERIAN GINSENG" FROM ALL COUNTRIES
Attachment Revised 2/6/09
TYPE OF
ALERT: Detention without Physical Examination (DWPE)
(Note: This import alert represents the Agency's current guidance to FDA
field personnel regarding the manufacturer(s) and/or products(s)
at issue. It does not create or confer any rights for or on any
person, and does not operate to bind FDA or the public)
PRODUCT: Foods labeled as being or containing "Siberian ginseng"
PRODUCT
CODE: 54F[][]12 Ginseng (Herbal & Botanicals, not Teas)
54E[][]12 Ginseng (Herbal & Botanical Teas)
54Y[][]04 Ginseng Unconventional Dietary Specialty
for Human or Animal
32Y[][]01 Ginseng, Ginseng, Alcoholic Beverage, N.E.C.
PROBLEM: Misbranding
PAF: LBL
PAC FOR COLL: 21008
COUNTRY: All
MANUFACTURER/
SHIPPERS FEI: See attachment
CHARGE: "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: Misbranding
CODE: LBL
RECOMMENDING OFFICE: CFSAN, Office of Compliance, Imports
Branch (HFS-606)
REASON FOR ALERT: 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 or dietary
supplement 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, food
ingredient, dietary ingredient or dietary supplement may be
identified as "ginseng" unless it is a botanical within the
genus Panax. However, many dietary supplements and their
ingredients that are or that contain the botanical
Eleutherococcus senticosus are often identified using the
term "Siberian ginseng." Because plants within the genus
Eleutherococcus are not the same genus as Panax, these
products cannot use the term "ginseng" in their name.
Accordingly, the dietary ingredient Eleutherococcus senticosus or
a dietary supplement containing it must identify the ingredient
using the Latin binomial Eleutherococcus senticosus or the
standardized common name "eleuthero." The term "Siberian ginseng"
cannot be used.
GUIDANCE: Districts may detain without physical examination (DWPE) after
conducting a labeling examination and confirming that the product
is misbranded in that the product is labeled as being or
containing "Siberian ginseng." The prohibition against using the
term "Siberian ginseng" applies to labeling, including its use in
the statement of identity, nutrition/supplement facts labeling,
ingredient listing, and general information statements on the
labeling. Please note that these labeling examinations should be
conducted on both bulk and retail packages.
The following lists the standardized common names for the
following Eleutherococcus senticosus and Panax spp. botanical
ingredients in dietary supplements, in accordance with 21 CFR
101.4(h):
Latin Binomial Standardized 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
Foods that are labeled as "Siberian ginseng" appear to be misbranded.
Products listed in the Attachment will be subject to detention without
physical examination.
If a firm or importer believes that their product should not be recommended
for detention under this import alert, they should forward information
supporting their position to FDA at the following address:
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Compliance/Imports Branch (HFS-606)
5100 Paint Branch Parkway
College Park, MD 20740
Questions may be directed to CFSAN, Office of Compliance/Imports Branch (HFS-
606) at (301) 436-2413.
PRIORITIZATION
GUIDANCE: I
FOI: No purging necessary
KEYWORDS: Ginseng; Siberian Ginseng; Panax Ginseng;
Eleutherococcus senticosus
Senticosus; Panax psuedoginseng var. japonica, Panax pseudoginseng
var. notoginseng, Panax quinquefolius; Tienchi ginseng; Japanese
ginseng; American ginseng; Asian ginseng.
PREPARED BY: David Krawetz, DIOP, HFC-170, 301-594-3872
DATE LOADED
INTO FIARS: May 7, 2004
IA #54-12 Revised 2/6/09
ATTACHMENT
Firm/Products on Detention Without Physical Examination:
Korea, Republic of (South) (KR)
Firm name and address: Product/product code
Neumed, Inc. NEUBO Premium
151-18 Buk-Ri, Namsa-Myeon, 54F[][]99
Cheoingu Yongin-Si, 2/6/09
Korea, Republic of (South)
FEI: 3006165522
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