STATEMENT Arthur Whitmore: (202) 205-4144 June 12, 1997 Consumer Hotline: (800) 532-4440 (Updated June 16 and 18, and July 2. See addendums at end for additional list of firms.) FDA WARNS CONSUMERS AGAINST DIETARY SUPPLEMENT PRODUCTS THAT MAY CONTAIN DIGITALIS MISLABELED AS "PLANTAIN" The Food and Drug Administration is warning consumers not to purchase or ingest 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 ingested. FDA has detected Digitalis in samples of raw material labeled "plantain" that has been used by various manufacturers as an ingredient 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. 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. Plantain is a perennial weed of the genus Plantago which includes more than 200 widely distributed species. 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 birdseed. It should not be confused with the tropical banana plant Musa paradisiaca, the fruit Plantain which resembles a banana and is sold in some grocery stores. The distributors or manufacturers of bulk single ingredient plantain and trade-name products which may contain Digitalis are listed at the end of this release. Following this list, under the heading "Retailers and Shops," is a listing of retailers such as herb shops that have purchased suspect plantain. FDA advises consumers who have purchased products labeled "plantain" or suspect that a tea product from one of these retailers contains plantain to contact the retailer for assurance the product does not contain plantain received from one of the distributors listed. The effects of Digitalis may include nausea, vomiting, dizziness, headache, confusion, hypotension (low blood pressure), vision disturbances and abnormal heart rate and rhythm. FDA recently conducted an investigation after receiving information on a young woman who experienced abnormal heart rate with heart block, a potentially life-threatening condition, after consuming a dietary supplement product labeled as containing plantain. The agency's laboratory analyses confirmed the presence of lanatosides, constituents of the herbal ingredient Digitalis lanata, in samples of the raw material labeled as plantain used in the product. Digitalis lanata is one of several species of the plant genus Digitalis, one source of an active ingredient in some prescription heart medications. On May 16 the agency issued a warning to consumers against using the product associated with the adverse event --CHOMPER-- an herbal laxative and cleansing agent distributed by Arise & Shine of Mount Shasta, Calif. Since then, other products containing Digitalis have been identified. The agency 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. 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. Persons 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 the products to FDA's MedWatch adverse event reporting line at 1-800-FDA-1088. (June 12, 1997, list follows. Addendum follows this list.) DISTRIBUTOR/MANUFACTURER PRODUCT AmeriHerb Plantain (bulk) Ames, Iowa Blessed Herbs Plantain (bulk) Oakham, MA Country Herbalist Plantain leaf Cushing, WI Herbarium, Inc. Plantain (bulk) Kenosha, WI Nature's Cathedral Plantain (bulk) Blairstown, IA Planet Earth Plantain leaf Spencer, WI Wise Woman Herbals Uriseptic tea Creswell, OR RETAILER/SHOP PRODUCT RECEIVED Ann Robben-Dott Uriseptic tea The Community Store Astoria, OR Aphrodisia Plantain leaf New York, NY Attn: Dispensary Uriseptic tea King County Natural Medicine Clinic Kent, WA Attn: Dr. Dipasquale/Dr. Lee-Engel Uriseptic tea Bastyr University-Pharmacy Seattle, WA Blue Nile Trading Company Plantain leaf Washington, DC Brighter Day Natural Foods Plantain leaf Savannah, GA Butterfly Herbs Plantain leaf Missoula, MT Canon City Herb Company Plantain leaf Canon City, CO Casa Verde Plantain leaf Chestnut Ridge, NY Chatham Herbary Plantain leaf Chatham, MA Connie Henry, RN Uriseptic tea Renton, WA Country Life Natural Food Plantain leaf Vanona, MN Country Life Natural Food-WV Plantain leaf Glenville, WV Country Life Natural Food-MN Plantain leaf Winona, MN Country Herbalist Plantain leaf Cushing, WV Country Life Natural Food Plantain leaf Glenville, WV Dawn Kimball Uriseptic tea Wise Woman Herbals Eugene, OR Death Rage Health Products Plantain leaf Birch Tree, MO Donna Caplan, ND Uriseptic tea Collaborative Health Works Montpeller, VT Dr. Luc Maes, ND, DC Maes Center for Natural Healthcare Uriseptic tea Santa Barbara, CA Dr. Beverely Yates, ND Uriseptic tea The Center for Natural Health Care Kailua Kona, HI Dr. Debra Glasser Green, MD Uriseptic tea Aurora Health Clinic Canby, OR Dr. Greg Garcia Uriseptic tea Portland, OR Dr. Mystique D. Grobe, ND Uriseptic tea Bellingham, WA Earth Ward Plantain leaf Amherst, NH Ebenezer Hills Mission Plantain leaf & powder Clarksville, AR Fare Share Coop Plantain leaf Richmond, VA Food Conspiracy Coop Plantain Tucson, AZ For Your Health, Water/alcohol tincture Denver Co French Broad Trading Plantain leaf Asheville, NC Fresh Air Natural Foods Plantain leaf Lynchburg, VA Goldenseal Plantain leaf Pittsburg, PA Good Herbs Extract in 1 oz. & 4 oz. Troy, MI bottles Gottfried's Plantain leaf & powder Spencer, TN Greene's Plantain leaf Huntington, IN Healin' Hollers Plantain leaf Old Joe, AR Herb Company Plantain leaf Independence, MO Home Health Resources Plantain leaf Piggott, AR Hutchinson Chiropractic Clinic Plantain leaf Hutchinson, KS Jacqueline Thomas, ND Uriseptic tea Wenatchee, WA Jean's Greens "ABDO-MENDS" (sold as Newport, NY loose tea & tea bags and bulk plantain) John Cosgrove, ND Uriseptic tea NaturePharm Richmond Hill, Ontario John's Natural Foods Plantain leaf Bayonne, NJ Just For Health Enterprises Unknown Denver, CO Kristin Stiles, ND Uriseptic tea Great Bend, PA Laura O'Neal, ND Uriseptic tea Maui East West Clinic Kahului, HI Lynn's Herb Shop Plantain leaf Hillsboro OR Margaret Wakefield, ND Uriseptic tea Olymic Integrative Medicine Bainbridge, WA Margaret's Magicals Unknown New York, NY Maria Perillo, ND Uriseptic tea Nauset Health Associates Orleans, MA Marion Hultgren, Inc. Plantain leaf Tucker, GA Meadow Sweet Herbal Apothecary Plantain leaf New York, NY Moon Magic Plantain leaf Genesco, NY Mt. Shasta Herb & Health Plantain leaf Mt. Shasta, CA Natural Health Products Plantain leaf & powder Hot Springs, NC Nature's Emporium Plantain leaf Elizabeth City, NC Nature's Goodness Plantain leaf Greenville, NC Nature's Products Plantain leaf Detroit, MI Nature's Mercantile plantain leaf Wichita, KS Nature's Magic Herb plantain leaf Louisville, KY Nature's Emporium Plantain leaf Elizabeth City, NC New Life Natural Foods Plantain leaf Pleasantville, NJ New Life Natural Foods & Herbs Plantain leaf Martinsburg, PA No Common Scents Plantain leaf Yellow Springs, OH No Name Nutrition Plantain leaf Omaha, NE Nostrand Health Foods Plantain leaf Brooklyn, NY Pacific Botanicals Plantain (bulk) Grants Pass, OR Phillips, Stretch, Breed ND's Uriseptic tea Institute of Complimentary Medicine Seattle, WA Polson's Natural Food Plantain leaf Antioch, IL Pure Herbs Plantain leaf Madison Height, MI Purple Herbs Plantain leaf Madison Height, MI Rainbear Plantain leaf Lititz, PA Renningers Plantain leaf & powder Rock Hill, SC Robersons Plantain leaf Batesville, MS Roesch's Natural Food Plantain leaf Kingsville, OH Ruth Cunningham Uriseptic tea Murphy, OR Sage Woman Herbs Plantain leaf & powder Colorado Springs, CO Sahara Mart Plantain leaf Bloomington, IN Schofield Roots & Herbs Plantain leaf Theodosia, MO Simply Herbs Plantain leaf Pikeville, TN Smile Herb & Book Shop Plantain leaf College Park, MD Southerlands Plantain leaf Maysville, NC Sugar Hill Botanicals Plantain leaf powder Franconia, NH Sunshine Herbs Plantain leaf Kings Mountain, NC Super Carrot Herbothecary Plantain leaf powder Prescott Valley, AZ Suzanne Scopes,ND Uriseptic tea Portland, OR Tao Natural Foods Plantain leaf Minneapolis, MN The Uncommon Herb Plantain leaf Oklahoma City, OK The Almond Tree Plantain leaf Harrison, AR The Five Elements of Health Plantain leaf Rochester, NY The Mustard Seed Plantain leaf Portsmouth, NH Vital Health Foods Plantain leaf Queens, NY Wedge Community Coop Plantain leaf Minneapolis, MN Wild Earth Herbs Plantain leaf Houston, TX Wish Garden Herbs Unknown Boulder, CO Wolfes, Inc. Plantain leaf Caveridge, MN Years to Your Health Plantain leaf & powder Irving, TX Ypsilanti Food Coop Plantain leaf Ypsilanti, MI ================================================================= ADDITIONAL INFORMATION (added June 16, 1997) ================================================================= Anna's Health Foods Anchorage, AK Plantain leaf-wild Anson, Rhonda Hudson, NY Plantain-wild Apothecary Rose Shed Pattersonville, NY Plantain-wild Berkshire Mtns Herb Co. Pittsfield, MA Plantain-wild Braley, Marilyn Houston, TX Plantain-wild Brown, Carole A. Spring Valley, CA Plantain leaf-wild Cahalan Health Foods San Jose, CA Plantain-wild Connone, Terry North Miami, FL Plantain-wild Cook, Sally Fresno, CA Plantain leaf-wild Delzeit, Betty Victoria, KS Plantain leaf-wild Distefano, Donna Decatur, GA Plantain-wild Earth Fare Asheville, NC Plantain-wild Eastern Gate Herbals Misson, BC, Canada Plantain-wild Fairewood Herbs Clinton, WA Plantain-wild FO Whiteley Truth or Consequence, NM George's Saw & Mower Shop Konkakee, IL Plantain-wild Gewecke, Mary Phoenix, AZ Plantain-wild Gibson, James Monitor, WA Plantain-wild Gifts of the Spirit Goldendale, WA Plaintain leaf-wild Good Nature Market Victoria, BC, Canada Plantain-wild Gunn, Steven Cove, AR Plantain-wild Hartzell, Dan Las Vegas, NV Plantain-wild Healing Arts College West Los Angeles, CA Plantain-wild Herb Shop Grants Pass, OR Plantain-wild Herbs for Kids Bozeman, MT Plantain-wild Hernandez, Robert Alhambra, CA Plantain leaf-wild Hollin, Glen Reno, NY Plantain leaf-wild Immekus, Carolyn St. Clair, MO Plantain leaf-wild In Harmony Herbs & Spices San Diego, CA Plantain-wild Juniper & Sage Bend, OR Plantain-wild Kirkland, Jane Springdale, AR Plantain-wild KW Botanicals San Anselmo, CA Plantain-wild Lauckhardt, Linda Big Bear City, CA Plantain leaf-wild Lee, W.H. (Mrs.) Lake City, CA Plantain leaf-wild LeMieux, Marcella Los Angeles, CA Plantain-wild LoPresti, Anthony El Paso, TX Plantain-wild McCauley, Laverne Townville, PA Plantain-wild McGee, Rick Santa Barbara, CA Plantain leaf-wild Mrs. Thompson's Eugene, OR Plantain-wild Naomi's Herbs Lenox, MA Plantain-wild New Mexico Herbal Center Albuquerque, NM Plantain leaf-wild New Leaf Market Santa Cruz, CA Plantain-wild Paulk, Ken Amarillo, TX Plantain-wild Pelton, Adrien Del Mar, CA Plantain-wild Pietsch, Jim Farmington, MN Plantain-wild Prima Fleur Botanicals, Inc. San Rafael, CA Plantain-wild Purple Shutter Herbs Burlington, VT Plantain-wild Rainbow Grocery Co-op, Inc. San Fransisco, CA Plantain-wild Rainbow Grocery Co-op, Inc. San Francisco, CA Plantain-wild Raugust, Cathie Ritzville, WA Plantain-wild Rhodes, Gary Barrington, IL Plantain-wild Rocky Mountain School of Botanical Studies Boulder, CO Plantain-wild Roller, Sharon Elizabeth, CO Plantain-wild Smith, Robert K. Independence, MO Plantain-wild Steenborg, William Y. Texarkans, TX Plantain-wild Syc, Chester Taylor, MI Plantain-wild Takahashi, Noelle Hayward, CA Plantain-wild Taylor, Virginia Yale, MI Plantain-wild The Herbalist Seattle, WA Plantain-wild Trujillo, Solomon Lakewood, CA Plantain-wild Tucker, Doris Arnington, TN Plantain-wild Weeds of Wonder Las Vegas, NV Plantain leaf-wild Wellspring Mount Vernon, WA Plantain leaf-wild Wood, Leslie Louisville, KY Plantain leaf-wild Yerba Buena Santa Monica, CA Plantain-wild =============================================================== Second Addendum (Added June 18, 1997) =============================================================== Harvest Health Grand Rapids, MI Plantain Natural Medicine Chicago, IL Plantain Trinity Herbs Bodega, CA Plantain =============================================================== Third Addendum (Added July 2, 1997) =============================================================== FIRM PRODUCT Amex Chemical plantain complex Chatsworth, CA Atrium Labs plantain powder Hebron, IL FCC Products plantain powder Livingston, NJ Gar Laboratories plantain extract Riverside, CA McZand's Herbal Inc. plantain Los Angeles, CA Medica Pharmaceutical Corp. plantain extract Belle Mead, NJ Nature's Design plantain Brooklyn, NY Penn Herb Company plantain Philadelphia, PA Todays Pharmacy plantain Philadelphia, PA White Crane Trading Co. plantain New York, NY Vege Kurl Corporation plantain extract and Glendale, CA complex ####