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In a statement issued June 12, 1997, the FDA announced that an undetermined amount of bulk Digitalis lanata leaf may have been mislabeled and sold as plantain leaf (Plantago major) on the American market. FDA believes that the adulterated plantain may have been incorporated into products by a variety of manufacturers and/or offered for sale in bulk herb departments. The FDA statement warns consumers not to ingest any product containing plantain without first verifying that the plantain does not come from a company that may have purchased the contaminated herb.
Industry associations are strongly advising all distributors and manufacturers to stop distributing plantain and plantain-containing products until they can be tested, and to have all stocks of plantain-containing products tested for the presence of Digitalis lanata.
FDA has developed a web page list of possibly affected manufacturers, distributors, and retailers. The updated list and the FDA's warning statement is online at their website:
http:/www.fda.gov/bbs/topics/NEWS/NEW00570.html
So far, the list of distributors and manufacturers who may have purchased adulterated plantain includes Herbarium, Inc., Planet Earth, Country Herbalist, AmeriHerb, Nature's Cathedral, Blessed Herbs, and Wise Woman Herbals. The most recent update adds to the list Amex Chemical, Atrium Labs, FCC Products, Gar Laboratories, McZand Herbal, Medica Pharmaceutical, Nature's Design, Penn Herb Company, Todays Pharmacy, White Crane Trading and Vege Kurl.The product contamination was initially believed to be limited to a product called Chomper, manufactured by Arise and Shine of Mt. Shasta, CA. The company voluntarily recalled suspect batches of the product upon learning of the possible adulteration. The FDA investigation began after a Massachusetts woman was hospitalized with cardiac problems after taking Chomper, marketed as an herbal laxative.
Digitalis, commonly known as foxglove, is the botanical source for powerful cardioactive compounds such as digoxin. Effects of ingesting Digitalis may include nausea, vomiting, dizziness, headache, confusion, hypotension, vision disturbances, and abnormal heart rate and rhythm.
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