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