Federal Regulations Affecting Gamma Butyrolactone (GBL)

Date: Jul 02, 2001

Synopsis: On February 18, 2000, Congress enacted the Date-Rape Drug ProhibitionAct, outlawing gamma  hydroxybutyric acid(GHB), popularly known as the "date-rape drug," and giving the Drug EnforcementAgency (DEA) the authority to regulate gamma-Butyrolactone (GBL), a precursor chemicalthat can be synthesized into GHB.[ii]  On April 24, 2000, DEA regulations relating to GBLwent into effect, requiring those who manufacture, distribute, import, and export GBL notintended for human consumption to register annually with the DEA and maintain detailedrecords of all GBL transactions.[iii]  This article provides an overview of the GBLregulations and the potential penalties for failure to comply with them.[iv]

Why GBL Is Regulated
Although GBL has legitimate uses, for example, as an industrial cleaner, it has thepotential for abuse as it is structurally and pharmacologically similar to GHB,[v]the "date-rape drug."  Lawenforcement authorities have identified GBL in many GHB clandestine laboratories anddocumented its use as a precursor in the synthesis of GHB.[vi]  In addition, when ingested, GBL is swiftlyconverted by the body into GHB and has been abused for its psychoactive effects.[vii]   

Regulations Apply to GBL Not for Consumption; GBL for Consumption May Be Illegal
The DEA regulations relate to GBL not intended for human consumption.[viii]  GBL intended for human consumption may,under certain circumstances, be considered a controlled substance and therefore illegal.[ix]  This article is limited to a discussion of GBL notintended for human consumption.

Those Affected by the DEA Regulations
Any person or company that manufactures any amount of GBL for distribution, ordistributes, imports, and/or exports any amount of GBL, must comply with the federalregulations.[x]  However, the DEA is currently reviewing availabledata to determine whether it should exempt transactions involving GBL amounts below acertain threshold.[xi]  The threshold issue will be subject to a separaterulemaking and will provide an opportunity for public comment.[xii]

Those who manufacture GBL solely for internal consumption are exempted from the DEAregulations.[xiii]  Also, agents and employees of registered partiesare not individually subject to the regulations, but rather are covered by the companiesthat retain or employ them.[xiv]

DEA Regulations for GBL

1.          AnnualRegistration

Every person or company that manufactures GBL for distribution, or distributes,exports, or imports GBL, must register annually for each type of GBL transaction.[xv]  Individual registrations are also required foreach location at which a transaction occurs.[xvi]

2.          RegistrationFees

As of April 24, 2000, for GBL manufacturers, distributors, importers, and exporters,each annual registration fee is $595.00 the first year and $477.00 each year thereafter.[xvii]  For GBL retailers, the fee is $265.00 the firstyear and $116.00 each year thereafter.[xviii] 

3.          RecordkeepingRequirements

GBL registrants must keep detailed records of all GBL transactions, includinginformation regarding the parties involved, the manner in which the GBL is packaged, andthe method of GBL transportation.[xix]

4.         SecurityObligations

All parties subject to the GBL regulations must provide effective controls andprocedures to guard against GBL theft and must report any suspicious activity to the DEA.[xx]  In addition, GBL handlers need to exercise cautionin selecting employees who will be directly involved in GBL transactions, for example, byscreening potential employees for felony offenses relating to a controlled substance. [xxi]

Penalties for Failure to Comply
Those who negligently fail to comply with the GBL regulations are subject to up toa $10,000 fine.[xxii]  Those who knowingly fail to comply with theregulations are subject to up to a $25,000 fine and/or one year in prison for the firstoffense, and up to a $50,000 fine and/or two years in prison for a subsequent offense.[xxiii] 

For more information, contact Douglas J. Behr at (202)434-4213 or behr@khlaw.com, Pamela Gauthier at 202-434-4291 or gauthier@khlaw.com or Lynn Owens at 202-434-4299 or owens@khlaw.com.

[i] Mr. Behr is a senior partner and Ms. Owens an associate in the litigation department of Keller and Heckman, LLP.  Ms. Gauthier is an associate in the food and drug department of the firm.  Mr. Behr, Ms. Owens, and Ms. Gauthier's practices include chemical product litigation and regulation.

[ii] Date-Rape Drug Prohibition Act, Pub. L. No. 106-172, 114 Stat. 7 (2000) (codified as amended at 21 U.S.C. §§ 801-971 (2000)).

[iii] 65 Fed. Reg. 21645 (2000).

[iv] This article is not intended to provide legal advice and is only a discussion of the potential legal issues raised by the Date-Rape Drug Prohibition Act and subsequent federal regulations.  If you manufacture, distribute, import, or export GBL, you must comply with federal and possibly state regulations and should seek legal advice.

[v] 65 Fed. Reg. 21645.

[vi] Id.

[vii] Id.; see also Stephen Zukin, M.D., Address before the Subcommittee on Oversight and Investigations, Committee on Commerce, U.S. House of Representatives (Mar. 11, 1999).

[viii] 65 Fed. Reg. 21645.

[ix] 65 Fed. Reg. 21645; see also 21 U.S.C. §§  802(32), 813.

[x] 21 C.F.R. § 1309.21.

[xi] 65 Fed. Reg. 21645.

[xii] Id.

[xiii] 21 C.F.R. § 1309.27.

[xiv] Id. § 1309.24.

[xv] Id. §§ 1309.21, 1309.22.

[xvi] Id. §§ 1309.23.

[xvii] Id. §§ 1309.11(a),(b).

[xviii] Id. § 1309.11 (c),(d).

[xix] Id. §§ 1310.03, 1310.06.

[xx] Id. §§ 1309.71, 1310.05(a)(1).

[xxi] Id. § 1309.72.

[xxii] 21 U.S.C. §§ 842(a), 842(c)(1)(B).

[xxiii] Id. §§ 842(a), 842(c)(2)(A), (B).