GBL Would Become A DEA Controlled Substance Under House Date Rape Bill

Gamma butyrolactone (GBL) would be classified as a controlled substance under the proposed Hillary J. Farias Date-Rape Prevention Drug Act. The bill (HR 2130), introduced June 10 by Rep. Fred Upton (R-Mich.), unanimously passed the House Commerce/ Health Subcommittee at a mark-up July 27. Senate companion legislation is being drafted; the House bill is expected to go before the full Commerce Committee in the next few weeks.

Under the bill, GBL would be classified as a List I Chemical by the Drug Enforcement Administration, which would define it as "used in manufacturing a controlled substance in violation of the [Controlled Substance Act]" and "important to the manufacturing of the controlled substance." GBL, when ingested into the body, is converted to gamma hydroxybutyric acid (GHB), which HR 2130 would separately place under Schedule I of the CSA.

At a March 11 hearing convened by Upton, DEA Deputy Director Terrance Woodworth reviewed three control measures that could be placed on GBL, including making it "a listed chemical with a level of control commensurate with its current industrial use" (¹ (Also see "GBL Control Measures Due To Possible Date Rape Use Being Explored" - Pink Sheet, 15 Mar, 1999.)). Upton, the chair of the Commerce/ Oversight & Investigations Subcommittee, called the hearing to examine possible control measures for date rape drugs, including GBL and GHB.

Federal law requires that manufacturers, distributors, importers and exporters of listed chemicals implement measures such as "obtaining proof of identity from their current customers," "maintaining retrievable receipt and distribution records" and "reporting to the [DEA] any suspicious orders."

Moreover, anyone involved in international transactions involving the chemical must notify DEA 15 days prior to the transaction. Manufacturers are further required to report annual production data, and DEA may inspect all chemical handlers to "ensure compliance with all applicable laws and regulations."

At the mark-up, Commerce Committee Chairman Tom Bliley (R-Va.) referred to the March 11 hearing, noting "the DEA, the Department of Justice, the FDA, and many state and local law enforcement officials all have lobbied to have these drugs listed as controlled substances. By passing HR 2130, we give law enforcement organizations the tools they need to get 'date rape' drugs off of the streets." Bliley was one of three cosponsors of the measure, along with Sheila Jackson-Lee (D-Tex.) and Bart Stupak (D-Mich.). Lee had introduced an identically named bill in January.

FDA requested a voluntary recall of all dietary supplement products containing GBL in a Jan. 21 "Talk Paper" (² (Also see "GBL-Containing Supplements Should Be Recalled - FDA "Talk Paper"" - Pink Sheet, 25 Jan, 1999.)). Since then, all the companies contacted by FDA have agreed to stop manufacturing and selling products, and all but one, RenewTrient Research, have initiated recalls.

However, sale of the products persists. On June 15, the agency released flyers warning about the dangers of dietary supplements containing GBL, GHB or 1,4 butanediol (BD) (³ (Also see "FDA Flyers Warn Consumers Of Dangerous BD, GBL, GHB Supplements" - Pink Sheet, 28 Jun, 1999.)). BD, an industrial solvent related to GHB, was the subject of an FDA "Talk Paper" issued May 11 (⁴ (Also see "FDA Warning On Sleep Aids/Muscle Builders With 1,4 Butanediol Issued" - Pink Sheet, 17 May, 1999.)).

Under Schedule I, GHB would be considered a substance with serious abuse potential for which there is "no currently accepted medical use." Manufacturers would be inspected every year and unauthorized sale of the substance would carry a maximum sentence of life in prison if death or serious bodily injury resulted from use of the product.

At the mark-up, an amendment offered by Stupak exempting facilities manufacturing GHB pursuant to an FDA approved IND from Schedule I physical security requirements was approved. Currently, there is an IND for GHB as a possible treatment for narcolepsy. Under the amendment, if the product were later approved for marketing by FDA, the drug would then be placed under Schedule III, but still carry Schedule I criminal penalties.

The bill also requires the HHS secretary to submit to Congress an estimate of "the number of incidents of the abuse of date rape drugs" in the most recent one-year period for which data are available. The first such report would be required by Jan. 15, 2000.

HHS, along with the Attorney General, also would have to develop an education campaign focusing on the dangers of date rape drugs, how to recognize symptoms associated with their use and how to respond when seeing such symptoms. An advisory committee providing recommendations on the campaign's implementation would be established within 180 days of the bill's passage; the campaign would commence within 180 days of the committee's establishment.