Import Alert 54-08

"Detention Without Physical Examination of Dried Bulk Plantain Due To The Presence Of Digitalis"

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.

Districts may detain without physical examination dried bulk plantain from the manufacturers/shippers identified in the Red List 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 301 796-6600.

All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Dried Bulk Plantain

"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)]."

OASIS charge code - POISONOUS

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).'

OASIS charge code - FALSE

and

"...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)]."

OASIS charge code - LIST INGRE