FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 

T99-21                     Print Media:         301-827-6242
May 11, 1999                
                           Consumer Inquiries:  888-INFO-FDA

FDA WARNS ABOUT GBL-RELATED PRODUCTS

FDA is warning the public of a new group of products being marketed as sleep aids that have been associated with at least 3 deaths and several severe adverse reactions. These products are chemically related to gamma butyrolactone (GBL) and gamma hydroxybutyric acid (GHB) substances that have been determined to pose a significant health hazard to the public. In particular, one of these products, 1,4 butanediol (BD) has been declared a Class I Health Hazard -- a potentially life-threatening risk -- by the FDA.

BD is a chemical that can cause dangerously low respiratory rates, unconsciousness, vomiting, seizures and death. BD may also increase the effects of alcohol and is even more dangerous when consumed with other depressant drugs.

Products that contain BD include Revitalize Plus, Serenity, Enliven, GHRE, SomatoPro, NRG3, Thunder Nectar and Weight Belt Cleaner.

Some of the suspect products may list 1,4 butanediol, tetramethylene glycol, gamma butyrolactone or 2(3H)-Furanone di-hydro on the label.

These products are listed as "party drugs" on internet sites, advertised in muscle-building magazines, and sold in health food stores as dietary supplements to aid in sleep. The FDA, however, considers these products unapproved new drugs and has conducted seizures of the product to prevent the sale to consumers and any further illnesses or deaths.

This is not the first time that products of this nature have caused a serious health hazard. In February, 1997, FDA re-issued a warning on GHB for body building and "recreational" uses. GHB continues to be an unapproved and potentially dangerous drug and cannot be legally marketed in the U.S. It has been implicated as a "date rape" drug.

On February 2, 1998, a California chiropractor was fined $2,000 and imprisoned for illegally distributing tainted liquids that sickened more than 100 partygoers at a New Year's Eve 1996 "rave" party in Los Angeles.

FDA warned consumers not to ingest the products blamed for the injuries, which were labeled Cherry fX Bombs, Lemon fX Drops and Orange fX Rush. They all contained 1.4 Butanediol.

In January, 1999, FDA issued a talk paper warning consumers about products containing GBL another product marketed as a dietary supplement, which when ingested, converts to GHB in the body.

GBL, GHB, and BD have been associated with reports of at least 122 adverse health effects, including the three deaths. In many cases, the consumers became unconscious or comatose and several required intubation for assisted breathing.

Health authorities believe manufacturers are renaming their products and substituting 1,4 butanediol for GBL. The effects of ingesting BD are as dangerous as those of GHB and GBL.

FDA can not assure the effectiveness or safety of any product for sleep inducement other than FDA approved drugs. People who use unapproved sleep inducement products, especially without proper medical supervision, may be unnecessarily exposing themselves to serious harm.

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