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
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
ATTACHMENT
Firm/Products on Detention Without Physical Examination:
Firm name and address: Product/product code
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