|FOOD AND DRUG
FOR IMMEDIATE RELEASE T99-5
Consumer Media: 888-Info-FDA
January 21, 1999
FDA WARNS ABOUT PRODUCTS CONTAINING GAMMA BUTYROLACTONE OR
GBL AND ASKS COMPANIES TO ISSUE A RECALL
The Food and Drug Administration is alerting
consumers not to purchase or consume products, some of which are labeled as dietary
supplements, that contain gamma butyrolactone (abbreviated as GBL). FDA has also asked the
companies that manufacture these products to voluntarily recall them. The agency has
received reports of serious health problems -- some that are potentially life-threatening
-- associated with the use of these products.
Although labeled as dietary supplements, these
products are illegally marketed unapproved new drugs. Products containing GBL are marketed
under various brand names including Renewtrient, Revivarant or Revivarant G, Blue Nitro or
Blue Nitro Vitality, GH Revitalizer, Gamma G, and Remforce. They are promoted with claims
to build muscles, improve physical performance, enhance sex, reduce stress and induce
GBL is also known by the chemical names
2(3H)-furanone dihydro; butyrolactone; gamma-butyrolactone; 4-butyrolactone;
dihydro-2(3H)-furanone; 4-butanolide; 2(3H)-furanone, dihydro; tetrahydro-2-furanone; and
GBL related products have been associated with
reports of at least 55 adverse health effects, including one death. In 19 of those cases,
the consumers became unconscious or comatose and several required intubation for assisted
breathing. Other reported effects included seizures, vomiting, slow breathing, and slow
heart rate. There are reports of at least 5 children under 18 years of age who have been
injured or who have suffered these kinds of effects.
When taken orally, GBL is converted in the body to
gamma hydroxybutyrate or GHB. GHB is a very potent unapproved drug. It is currently being
investigated under the supervision of doctors for the treatment of narcolepsy. Because of
its serious side effects, GHB should not be taken unless in the context of these FDA
approved investigations. FDA and the Justice Department have ongoing criminal enforcement
actions against GHB. GBL should not be taken.
Products containing GBL are sold in liquid and
powder form. They are sold via the Internet, in some health food stores, and in some
gymnasiums and fitness centers.
Consumers are advised to dispose of any products
of this type in their possession. If they have experienced adverse health problems from
use of these products, they should promptly contact a physician. FDA requests consumers
and physicians to report adverse events to FDA's MEDWATCH 1-800-332-1088.
The Trimfast Group, Inc. has agreed to recall the
product Revivarant, 32 ounces of liquid in a plastic bottle, and Revivarant G, 200 grams
of powder in a pill bottle. Other companies manufacturing products containing GBL are
being asked by the FDA to voluntarily recall them.
FDA is considering all potential regulatory
actions at its disposal if products containing GBL are not recalled. The agency will act
expeditiously to protect the public health.