Press Office
Food and Drug Administration
U.S. Department of Health and Human Services
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
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