The NCAA News - News and Features

The NCAA News -- February 1, 1999

FDA issues dietary supplement alert

The Food and Drug Administration (FDA) issued an alert January 21 advising consumers not to purchase or consume certain products, some of which are labeled as dietary supplements, that contain gamma butyrolactone (GBL).

The FDA also has asked the companies that manufacture those products to recall them voluntarily. The agency has received reports of serious health problems -- some potentially life-threatening -- associated with the use of the products.

"We really want to get out a clear warning to consumers that this is a dangerous product, and they should not be using it," said Joe Levitt, the FDA's director of food safety.

Although labeled as dietary supplements, the products are illegally marketed unapproved new drugs. The government says GBL is a derivative of a powerful party drug banned in the United States since 1991.

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 of building muscles, improving physical performance, enhancing sex, reducing stress and inducing sleep.

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 five children under 18 years of age who have been injured or who have suffered similar effects. Several GBL users were found incoherent while driving, and one was involved in a car crash.

When taken orally, GBL is converted in the body to gamma hydroxybutyrate (GHB). GHB, a very potent unapproved drug with serious side effects, should not be taken unless in the context of current FDA-approved investigations studying its effect in the treatment of narcolepsy.

Because GBL breaks down into the banned GHB drug, it is by law illegal, the FDA said.

Products containing GBL are sold in liquid and powder form. They are sold online, 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 at 800/332-1088.

The Trimfast Group, Inc., already 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. The FDA is considering all potential regulatory actions at its disposal if products containing GBL are not recalled.