On January 27, 2015, the federal Food and Drug Administration published a notice seeking public comments on the World Health Organization’s (WHO) recommendation to impose international manufacturing and distribution restrictions on certain chemicals, including gamma butyrolactone (GBL). GBL is widely used as an industrial solvent but is regulated under the federal Controlled Substances Act (CSA) because it may be diverted for illicit purposes. The WHO’s recommended restrictions could impair companies’ ability to use GBL for legitimate commercial purposes and disrupt exemptions to federal CSA regulatory requirements that are critical to a wide variety of industries in the U.S. which use GBL in their operations. Comments must be submitted to the FDA no later than February 26, 2015. The FDA has not scheduled a public meeting on this issue, but affected stakeholders likely will request one.
This FDA regulatory action arises from a United Nations treaty, the 1971 Convention on Psychotropic Substances, to which the U.S. is a party. The treaty’s purpose is to establish a global, comprehensive approach to restrictions on psychotropic substances and ensure that they are used only for legitimate purposes. The WHO advises the United Nations on issues pertaining to the 1971 Convention and makes recommendations regarding the addition of regulated substances to the treaty. The WHO has recommended that GBL be added to Schedule I of the 1971 Convention. Under the CSA, the Secretary of State must inform the FDA of the WHO’s recommendations, and the FDA in turn must publish a notice and seek comments as it did on January 27.
The U.S. regulates psychotropic and other substances through the CSA, codified at 21 U.S.C. sections 801 et seq. Consistent with its status as a party to the 1971 Convention, the U.S. must consider the WHO’s recommendations. If GBL is added to Schedule I of the 1971 Convention, then the U.S. would be obliged to enact GBL-related legislation, i.e., an amendment to the CSA, consistent with the treaty. The WHO’s recommendations could require, for example, that the U.S. limit use of GBL to “very limited” medical and scientific purposes. The FDA acknowledges that “Additional [federal] controls will be necessary to fulfill U.S. obligations if GBL is controlled under Schedule I of the 1971 Convention.”
Such additional controls may impair companies’ use of GBL for commercial industrial uses. They also may undermine current federal regulatory exemptions to GBL mixtures. Under 21 C.F.R. Section 1310.12(d), GBL in mixtures at 70% or less, and GBL in completely formulated paints and coatings, are exempted from the extensive license, reporting and recordkeeping requirements of the CSA. The Drug Enforcement Agency promulgated these exemptions in 2010 in recognition of the fact that such preparations are not susceptible to diversion for illicit use, are widely used for industrial purposes and are critical in many industrial applications. Hence, the WHO’s recommendations may directly affect legitimate commercial uses of GBL and these important regulatory exemptions from CSA requirements.
The U.S. Secretary of State is developing its position on the WHO’s recommendations in preparation for a meeting of the United Nations Commission on Narcotic Drugs in March 2015. Affected stakeholders are urged to submit comments to the FDA, so that the agency may appropriately support the development of the U.S. Secretary of State’s position on the WHO’s recommendation at the upcoming meeting.