IA #54-08 - 7/1/97, "DETENTION WITHOUT PHYSICAL EXAMINATION OF DRIED BULK
            PLANTAIN DUE TO THE PRESENCE OF DIGITALIS"


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  7/1/97

                   MANUFACTURERS/SHIPPERS OF DRIED BULK PLANTAIN


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