GBL Control Measures Due To Possible Date Rape Use Being Explored

The Drug Enforcement Administration is "reviewing various control measures of GBL" that may reduce the possibility the substance could be converted into the related compound GHB and used as a date rape drug. DEA Deputy Director Terrance Woodworth announced the possibility in comments prepared for a March 11 House Commerce/Oversight & Investigations Subcommittee hearing on date rape drugs.

"If GHB is placed under Schedule I or II of the [Controlled Substance Act], GBL could be treated as an analog for the purposes of criminal prosecution if it is being distributed for human use outside of an FDA approved Investigational New Drug," Woodworth's comments state. Gamma-butyrolactone (GBL) is a precursor of gamma-hydroxybutyrate (GHB). There is a current IND for GHB as a treatment for narcolepsy.

Schedule I controlled substances pose the most serious potential for abuse and have "no currently accepted medical use," while substances covered under Schedule II have a "currently accepted medical use with severe restrictions."

GBL, which a handful of companies have been manufacturing and distributing as a liquid dietary supplement, converts to GHB once it is ingested. In a Jan. 21 "Talk Paper" FDA asked companies selling GBL products to voluntarily recall them and discontinue their manufacture after receiving 55 adverse event reports, including one report of a death and others where "consumers became unconscious or comatose and several required intubation for assisted breathing," after using GBL products ("The Tan Sheet" Jan. 25, p. 6).

Of the seven companies contacted by FDA, all but one have complied. Cocoa Beach, Fla.-based RenewTrient Research stopped selling the product RenewTrient but so far has refused to recall it.

In a Feb. 11 letter to the agency, RenewTrient Research asks FDA to respond within 30 days with proof GBL presents a risk to consumers. If the agency does not do so, RenewTrient said it may begin selling the product again ("The Tan Sheet" Feb. 22, p. 12).

Woodworth's comments note that "as there are no regulatory controls imposed on handlers of analogs, the licit industrial or pharmaceutical use of GBL would be unencumbered by this method of control."

However, the DEA official also goes on to state "alternatively, if GHB is controlled in any schedule of the CSA, GBL can be controlled as an immediate precursor in the same or lower schedule as GHB. The full range of CSA drug control measures would then apply to GBL."

A third and final method of "controlling GBL distribution and use by clandestine manufacturers" would be to "make GBL a listed chemical with a level of control commensurate with its current industrial use," Woodworth told the subcommittee in his prepared remarks.

Both the second and third options could be accomplished by following a standard notice-and-comment rulemaking. The DEA published a request for information "about the industrial uses and handling of GBL" in the Oct. 23, 1998 Federal Register.

Woodworth also expressed concern due to the relative simplicity of converting GBL into GHB. "The clandestine synthesis involves the use of two common, non-regulated chemicals: [GBL]...and lye." Furthermore, "no special chemical expertise" is needed to complete the conversion, he noted.

National Institute on Drug Abuse Clinical and Services Research Director Stephen Zukin, MD, also expressed concern about the ease of converting GBL to GHB. In written comments, Zukin says "GHB is relatively easy to make from common ingredients with recipes available on the Internet and in underground literature."

The Texas Attorney General's office is reportedly preparing lawsuits against manufacturers and distributors of GBL-containing dietary supplements ("The Tan Sheet" Feb. 8, In Brief).

The Centers for Disease Control & Prevention also recently reported adverse events associated with the ingestion of GBL-containing products in Minnesota and New Mexico. Both states' AG's offices said they are not aware of any legal action being undertaken.

The Nonprescription Drug Manufacturers Association has alerted consumer groups to the dangers of GBL used as a dietary supplement because of the substance's abuse potential.