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. 

T97-10                            Brad Stone       (301) 443-3285
February 18, 1997                 
                                  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.
                              -More-                                 Page 2, T97-10, GHB
     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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