[U.S. Food and Drug Administration]

FDA Medical Bulletin * Summer 1997 * Volume 27 Number 2

FDA WARNS AGAINST DIETARY
SUPPLEMENT PRODUCT, "CHOMPER"

On May 10, 1997, the Food and Drug Administration received a report of complete heart block occurring in a previously healthy, 23-year old woman who had ingested a regimen of botanical products for the purpose of "internal cleansing." The patient was found to have an elevated serum digoxin level. Laboratory analysis by FDA of the patient's botanical products indicated that the product "Chomper" (distributed by Arise and Shine of Mt. Shasta, California) contained a digitalis-like substance. Based on this information, the FDA issued an initial warning to consumers on May 16, 1997, not to purchase or consume the product "Chomper."

Additional investigation by FDA laboratories of the product "Chomper" revealed that it contained compounds characteristic of the primary glycosides found in the toxic plant Digitalis lanata. Analysis of the individual raw ingredients comprising the product "Chomper" indicated that the ingredient listed on the label as "plantain" was, instead, Digitalis lanata. Digitalis lanata leaves contain numerous cardiac glycosides including, among others, the precursor molecules of digoxin and digitoxin, potent medications available only by prescription in the United States.

Mislabeled plantain has been found to have been distributed to numerous other manufacturers to be used as an ingredient in making various dietary supplement products for retail sale. These products may list "plantain" as one of their ingredients on the labels, and are sold with a variety of claims. In addition, some of the suspect plantain has been distributed to retailers who sell the product in bulk for making tea or who use the product in blends of specialty teas for sale to consumers. On June 12, 1997, the FDA issued an additional warning in which consumers were advised not to purchase or ingest certain dietary supplement products labeled as containing "plantain" because they may contain cardiac glycosides, and that ingestion of these products may cause life-threatening cardiac arrhythmias, including cardiac arrest.

Health care professionals should be aware that individuals who have ingested these products, depending on the amount and extent of exposure, and the patient's underlying susceptibility, may be at risk for severe cardiac arrhythmias secondary to the cardiac glycosides derived from Digitalis lanata. Other potential side effects include anorexia, nausea, vomiting, dizziness, headache, confusion, hypotension, and vision disturbances. The FDA continues to investigate the mislabeling of the raw material labeled as "plantain," and to work with manufacturers to identify any dietary supplement products that may contain cardiac glycosides to ensure that they are recalled from commercial channels. Consumers who have experienced adverse effects associated with the use of the products and health care professionals who have treated them may report the event to FDA's MedWatch adverse event reporting line (1-800-FDA-1088). Updated information on firms and products that may contain mislabeled plantain may be obtained from the FDA's Consumer Hotline (1-800-FDA-4010) or access the Dietary Supplements section of the FDA "Foods" website on the FDA homepage (http://www.FDA.gov).

REPORT SERIOUS ADVERSE EVENTS AND PRODUCT PROBLEMS TO MEDWATCH
1-800-FDA-1088

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