FDA Requests Comments on WHO Recommendation to Classify Two Common Industrial Solvents as Psychotropic Substances

On January 27, 2015, the Food and Drug Administration (FDA) requested comments on a recommendation by the World Health Organization (WHO) to classify two common industrial solvents – gamma-butyrolactone (GBL) and 1,4-butanediol (BDO) – as psychotropic substances under Schedule I of the 1971 Convention on Psychotropic Substances. See 80 Fed. Reg. 4283. The comments will be used by the Secretary of Health and Human Services (HHS) to prepare a recommendation on the WHO proposal to the Secretary of State, which will be binding on the U.S. representative to the upcoming 58th Session of the UN Commission on Narcotic Drugs (CND) in Vienna, Austria, on March 9-17, 2015. At the Vienna meeting, CND may accept the WHO recommendations, reject the recommendations, or decide to control the chemicals in another way (i.e., under a different Schedule of the Convention).

FDA notes that if either chemical – or any of the other chemicals that are also recommended for listing, but are not addressed here because they have few, if any, legitimate industrial uses – are added by CND to Schedule I of the Psychotropic Convention, the U.S. will have to impose additional controls on the chemical(s) under the Controlled Substances Act (CSA) administered by the Drug Enforcement Administration (DEA). Although FDA does not elaborate on what those controls might consist of, they would likely include additional restrictions on manufacture, distribution, import, and export of the chemicals, as well as enhanced recordkeeping and reporting requirements. For example, Article 2(7)(a)(i) of the Psychotropic Convention states that parties shall require licenses for manufacture, trade, and distribution of Schedule I substances. Moreover, Article 7(a) provides that parties must “[p]rohibit all use [of Schedule I substances] except for scientific and very limited medical purposes by duly authorized persons,” although Article 2(7)(a) allows individual parties to notify the UN that they cannot do so as a result of “exceptional circumstances,” in which case the party need only “take into account” the prohibition “as far as possible.”

It is worth noting that GBL is already regulated under the CSA as a precursor to gamma-hydroxybutyric acid (GHB), which is a commonly abused central nervous system depressant drug that is currently regulated under Schedule II of the Psychotropic Convention and Schedule I of the CSA. In particular, GBL is classified under the CSA as a “List I” precursor (not to be confused with a CSA Schedule I or other controlled substance), and thus is already subject to significant DEA controls. In addition, some U.S. states and authorities in some other countries already regulate GBL directly as a controlled substance or its equivalent. Nevertheless, the addition of GBL to Schedule I of the Convention would likely require new and more stringent controls in most jurisdictions. Additional information on the basis for the WHO recommendation for GBL (including the chemistry of the chemical, abuse potential, legitimate uses, and current regulation around the world) can be found in the 2014 GBL Critical Review Report of the WHO Expert Committee on Drug Dependence.

BDO is also a precursor to GHB but is not currently regulated under the CSA. It is regulated in several U.S. states and other countries as a precursor or controlled substance equivalent. Once again, however, if it is added to Schedule I of the Psychotropic Convention, it will likely become subject to substantial additional restrictions. Additional information on the basis for the WHO recommendation for BDO can be found in the 2014 BDO Critical Review Report of the WHO Expert Committee on Drug Dependence.

FDA will accept written comments on the WHO recommendations until February 26, 2015. Requests for a public meeting will be accepted until February 6, 2015.