This is the retyped text of a "FDA Talk Paper"

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. Talk Papers are not intended for general distribution outside FDA, but all information in them is public, and full texts are releasable upon request.

T97-7
February 18, l997

Brad Stone: 301-443-3285
Consumer Hotline: 800-532-4440

FDA RE-ISSUES WARNING ON GHB

In recent months there has been a resurgence of media and public interest in the use of gamma hydroxybutyric acid (GHB) for body building and "recreational" uses. Despite renewed claims that it is legal, GHB continues to be an unapproved and potentially dangerous drug and cannot be legally marketed in the U.S. Therefore, FDA is renewing its warning against the use of this product. The following can be used to answer questions:

GHB is a chemical that has been promoted as a steroid alternative for body building and other uses for several years. Recently it has gained favor as a recreational drug because of its intoxicating effects. Although in the past GHB has undergone clinical testing for several indications, it has never been approved for sale as a medical product in this country.

Starting in 1990, FDA began an intense investigation of GHB distribution after numerous cases of GHB-related illness were reported. Reported symptoms have included vomiting, dizziness, tremors and seizures. Many of those injured required hospitalization, and some deaths have been linked to the consumption of GHB products.

By the end of 1991, FDA and the Department of Justice had taken enforcement action against several firms and individuals involved in manufacturing, distributing and promoting GHB. The agency also instituted an automatic detention policy to prevent products containing GHB from being imported. These actions -- along with embargoes, public education campaigns and other measures taken by state and federal authorities -- appeared to temporarily diminish the distribution and abuse of GHB.

Recently, however, there appears to be a resurgence in the abuse of GHB: virtually all of the products now encountered have been produced in clandestine laboratories. This increase in use has been accompanied by an increase in reports of GHB-related injuries, including deaths.

Although some promotion schemes occasionally make unlawful claims that GHB is a legal drug, it is illegal for any person to produce or sell GHB in the U.S. FDA's Office of Criminal Investigations is working with United States Attorneys Offices around the country to arrest, indict and convict individuals responsible for these illegal operations. FDA, the Centers for Disease Control and Prevention and the Drug Enforcement Administration are continuing to monitor GHB abuse and to develop the most effective measures to protect the public health.

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This is the retyped text of a "FDA Talk Paper"

FDA TALK PAPER

FDA RE-ISSUES WARNING ON GHB

FDA
TALK PAPER