IA #54-08 - 7/1/97, "DETENTION WITHOUT PHYSICAL EXAMINATION OF DRIED BULK
PLANTAIN DUE TO THE PRESENCE OF DIGITALIS", ATTACHMENT 4/6/07
TYPE OF ALERT : DETENTION WITHOUT PHYSICAL EXAMINATION
(Note: This import alert represents the Agency's guidance to FDA field
personnel regarding the manufacturer(s) and/or product(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 : Dried Bulk Plantain
PRODUCT CODE : 54Y[][]99
PROBLEM : Poisonous and deleterious substance (PSNC)
PAC FOR
COLLECTION : 03R801
COUNTRY : See Attachment
MANUFACTURER/
SHIPPER : See Attachment
CHARGE : The product is subject to refusal of admission pursuant
to Section 801(a)(3) in that it appears to contain or
bear a poisonous or deleterious substance (digitalis
lanata) which may render it injurious to health
[Adulteration, Section 402(a)(1)].
and
The product is subject to refusal of admission pursuant to
Section 801(a)(3) in that its labeling appears to be false
or misleading [Misbranded, 403(a)(1)]; it appears to be
offered for sale under the name of another food (dried
plantain) [Misbranded, 403(b)]; and it appears to be
fabricated from two or more ingredients but fails to declare
the ingredient digitalis by its common or usual name
[Misbranded, 403(i)(2)].
RECOMMENDING
OFFICE : CFSAN/Division of Enforcement, Import Branch (HFS-606)
REASON FOR
ALERT : Investigation of a consumer illness of a young woman after
consumption of a colonic type cleanser, "Arise & Shine's
Chomper," revealed that one of the raw materials of the
product is a dried form of plantain, a perennial weed of the
genus Plantago which includes more than 200 widely
distributed species. This should not be confused with the
tropical plant Musa paradisiaca, a fruit resembling a banana
that is sold in some grocery stores.
Lanatosides, constituents of the herbal ingredient,
Digitalis lanata, were confirmed in samples of the raw
material labeled as "plantain." Digitalis lanata, one of
several species of the plant genus, Digitalis, is a potent
active ingredient in prescription heart medications. The
effects of digitalis may include nausea, vomiting,
dizziness, headache, confusion, hypotension (low blood
pressure), vision disturbances, and abnormal heart rate
with heart block, a potentially life threatening condition.
GUIDANCE : Districts may detain without physical examination dried bulk
plantain from the manufacturers/shippers listed on the
attachment to this alert.
Chapter 8 of "Drug Analysis by Chromatography and
Microscopy," by Egon Stahl, may be used to identify
digitalis. For questions or issues concerning science,
science policy, sample collection, analysis, preparation, or
analytical methodology, contact the Division of Field
Science at (301) 443-3320 or 3007.
PRIORITIZATION
GUIDANCE : I
FOI : No purging is required.
KEYWORDS : Dried Plantain, Arise & Shine's Chomper, Digitalis
PREPARED BY : Fredda C. Shere-Valenti, DIOP, (301) 443-6553
DATE LOADED
INTO FIARS : July 1, 1997
ATTACHMENT - IA #54-08 4/6/07
MANUFACTURERS/SHIPPERS OF DRIED BULK PLANTAIN
CHINA (CN)
MANUFACTURERS/SHIPPERS PRODUCT
Guangzhou P'Product Herba Plantaginis
Shiji Chadong Industry Panyu (Plantain Herb)
Guangzhou 54E[][]99
China
FEI# 3004432897 4/6/07
GERMANY
Paul Muggenburg GmbH & Company
Bahnhofstrasse 2
Alveslohe, Germany 2081
FEI# 1000164238
Krauter Mix (Trockengemuse)
P.O. Box 97355
Seit 1919/Weisentherden Street
Abstwind, Germany
FEI# 1000267510
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