May 11, 1999
Print Media: 301-827-6242
Broadcast Media: 301-827-3434
Consumer Inquiries: 888-INFO-FDA
FDA WARNS ABOUT GBL-RELATED
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
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
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.
Top of Page
(To return - Click Back On Your Browser)