Colorado State University Extension
SafeFood Rapid Response Network


SafeFood Newsletter - Summer 1997 - Vol 1, No. 4

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FDA Warns Against Mislabeled Dietary Supplements

The FDA is warning consumers not to consume certain dietary supplement products containing "plantain" because the products may contain digitalis, a plant that contains powerful heart stimulants that can cause life-threatening heart reactions including cardiac arrest, if consumed.

FDA has detected digitalis in samples of raw material labeled "plantain" that have been used by various manufacturers as ingredients in making dietary supplement products. These products may list "plantain" as one of their ingredients on the labels and are sold with a variety of claims. 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 consumer purchase.

Plantain is a perennial weed of the genus Plantago. It is used in herbal remedies as a laxative and in poultices. Plantain is grown commercially for use in forage mixtures and for use of its seeds in bulk laxatives and in birdseed. It should not be confused with the tropical banana plant Musa paradisiaca, the fruit plantain which is similar to a banana and is sold in some grocery stores.

The FDA advises consumers who have purchased products labeled "plantain" or suspect that a tea product contains plantain, to contact the retailer for assurance the product does not contain plantain received from one of the implicated distributors.

The FDA continues to investigate the mislabeling of raw material labeled as "plantain," and to work with manufacturers to identify any dietary supplement products that may contain digitalis to ensure they are recalled from commercial channels. Effects of digitalis may include nausea, vomiting, dizziness, headache, confusion, low blood pressure, vision disturbances and abnormal heart rate and rhythm.

Consumers should read the ingredient label on dietary supplement products to see if "plantain" is listed as an ingredient. For updated information on firms and on products that may contain Digitalis, consumers may call 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/). The lists will be updated as more products are identified, so consumers who use plantain-containing products should check regularly.

Individuals who have experienced adverse effects associated with the use of these products should see a doctor. Consumers and health professionals can report adverse events associated with these products to FDA's MedWatch adverse event reporting line at 1-800-FDA-1088.

Source: FDA Press Release, June 12, 1997.

Updated Monday, August 29, 2011