| U.S. Food and Drug Administration |
FDA Talk Paper, Nov 21, 2000
FDA WARNS AGAINST CONSUMING DIETARY SUPPLEMENTS CONTAINING TIRATRICOL
The Food and Drug Administration is again warning consumers of products
marketed as dietary supplements that contain tiratricol, also known as
triiodothyroacetic acid or TRIAC, a potent thyroid hormone that may cause
serious health consequences including heart attacks and strokes. Despite four
recalls over the past seven months, various products that contain tiratricol may
still have reached consumers. FDA urges all consumers to stop using such
products immediately.
On November 11, 1999, FDA warned the public against consuming Triax Metabolic
Accelerator, a dietary supplement for weight loss by Syntrax Innovations, Inc.,
Cape Giradeau, Mo. Since this action, several other firms have recalled similar
products containing tiratricol. Distribution of these products has been
primarily through retail sales to health food stores, fitness centers, and
gymnasiums. There have been four additional such recalls:
- J.N.G. Sports Supplement Distributors, Bloomsburg, Pa., recalled a product
called Tricana Metabolic Hormone Analogue, 1 mg. capsules, which were labeled
as an "extremely effective fat burner, working especially well for conditions
of obesity and reducing problematic areas of fat (cellulite)". This recall
letter was issued on April 6, 2000.
- Thermo-Life International, San Carlos, Ca., also recalled Tricana
Metabolic Hormone Analogue from nine direct wholesale accounts on April 6,
2000, and requested sub-recalls by the wholesalers. The wholesalers reportedly
sold this product through the Internet.
- Gentech LLC., Edison, N.J. recalled a product containing tiratricol on
April 11, 2000. This firm called its product "Tria-Cutz, Thyroid Stimulator,
Dietary Supplement Capsules," and sold it in 90-capsule bottles containing
1000 mcg (1 mg) per capsule. The instructions directed users to take 1 capsule
2-3 times a day. The product bore labeling claims similar to those of Tricana
Metabolic Hormone Analogue. Tria-Cutz was distributed to 45 retail units
(stores/gyms) and to 30 individuals totaling about 1570 bottles.
On September 12, 2000, ATF Fitness Products Inc., Oakmont, Pa. recalled a
similar product called "Sci-Fi-Tri-Cuts Dietary Supplement Capsules." Although
the product contains 1000 mcg (1mg) of tiratricol, the labeling does not include
indications for use and does not make any claims kind. The product was sold to
135 accounts, most of which were gyms and health food stores.
FDA urges all individuals who may have purchased these products, or any
product containing tiratricol, to stop using them immediately and, in addition,
to consult their health care professional if they are experiencing any adverse
effects, which may include insomnia, nervousness, sweating, and diarrhea.
The text in this article was prepared by the FDA Office of Public Affairs.