Posted: 18 Oct 2018 04:47 AM PDT
We previously blogged on the Drug Enforcement Administration’s (DEA’s) rescheduling of Epidiolex. In that blog we highlighted that further action by the World Health Organization (“WHO”) and the UN Commission on Narcotic Drugs (“CND”) could further affect scheduling of cannabidiol (“CBD”) and cannabis in the United States. The Food and Drug Administration’s (“FDA’s”) recent notice on international scheduling, International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; ADB-FUBINACA; ADB-CHMINACA; Cyclopropyl Fentanyl; Methoxyacetyl Fentanyl; para-Fluoro Butyrfentanyl; Tramadol; Pregabalin; Cannabis Plants and Resin; and Eight Additional Substances; Request for Comments, 83 Fed. Reg. 50938 (Oct. 10, 2018), provides an opportunity for the regulated industry to comment on these actions.
By way of background, the United States is a signatory to the 1961 Single Convention on Narcotic Drugs and the 1971 Convention on Psychotropic Substances (“Psychotropic Convention”) (together “international drug control treaties”) designed to establish effective control over international and domestic traffic in controlled substances. 21 U.S.C. § 801(7). The U.S. is obligated to enact drug control laws consistent with the scheduling under the treaties. The CND, of which the U.S. is a voting member, is the United Nations regulatory body that makes decisions related to amending the treaties. The WHO serves as an advisory group that makes recommendations to the CND related to additions or changes to drugs controlled under the treaties. The WHO utilizes an Expert Committee on Drug Dependence (“ECDD”) to conduct evaluations of substances (called “critical reviews”) that form the scientific and medical basis for recommendations to the CND. The CND will next meet in March 2019 to consider WHO’s recommendations.
WHO previously conducted a critical review of CBD at its June 2018 meeting. WHO has also announced that the ECDD will meet between November 12-18, 2018, to conduct a critical review of a number of substances including cannabis. (The ECDD is also conducting a critical review of several synthetic cannabinoids and fentanyl analogues, as well as tramadol and pregabalin.)
First, in regard to CBD, the ECDD has already recommended that pure CBD should not be scheduled within the international drug conventions as it “was not found to have psychoactive properties, and presents no potential for abuse or dependence.” WHO, News Briefing-40th WHO Expert Committee on Drug Dependence (ECDD) (Sept. 13, 2018). This means that WHO will very likely send a recommendation to the CND recommending decontrol of CBD. As previously discussed, DEA rescheduled only FDA-approved drugs containing CBD, a cannabinoid extract from cannabis, with no more than 0.1 percent tetrahydrocannabinols (“THC”) in Schedule V of the Controlled Substances Act. All other CBD formulations remain Schedule I controlled substances. Remember also, that one of the reasons DEA provided for keeping CBD in Schedule V was to comply with the international treaties.
We noted in our October 1, 2018, post that for rescheduling the Epidiolex CBD formulation, DEA sought and received a scheduling evaluation from HHS. We have had the opportunity to review the HHS eight-factor analysis provided to DEA as part of the Epidiolex rescheduling. HHS concluded, based on its scientific and medical eight factor evaluation required by 21 U.S.C. § 811(c), that CBD does not have significant potential for abuse and could be removed from control, but to maintain treaty obligations, recommended that DEA place CBD in the Schedule V, the least restrictive schedule. Department of Health and Human Services, Basis for the Recommendation to Place Cannabidiol in Schedule V of the Controlled Substances Act, 2-3 (May 16, 2018). Thus, the actions by the CND could impact further scheduling of CBD in the U.S.
Second, in regard to cannabis, the June 2018 ECDD conducted a pre-review of:
As we asked in our prior post, if CND removes CBD from regulation under the international drug control treaties, will HHS and DEA support descheduling all CBD formulations? Likely more controversial will be what recommendations WHO provides related to cannabis, THC or other extracts and how will the U.S. react to any recommendations to reschedule these substances.
HHS will provide responses to WHO in regard to its solicitation of information related to its review of these substances. Thus, we encourage interested persons to provide comments to HHS through the FDA notice for public comments by October 31, 2018 to ensure that all of the relevant information is included as part of the HHS submission to WHO.
By way of background, the United States is a signatory to the 1961 Single Convention on Narcotic Drugs and the 1971 Convention on Psychotropic Substances (“Psychotropic Convention”) (together “international drug control treaties”) designed to establish effective control over international and domestic traffic in controlled substances. 21 U.S.C. § 801(7). The U.S. is obligated to enact drug control laws consistent with the scheduling under the treaties. The CND, of which the U.S. is a voting member, is the United Nations regulatory body that makes decisions related to amending the treaties. The WHO serves as an advisory group that makes recommendations to the CND related to additions or changes to drugs controlled under the treaties. The WHO utilizes an Expert Committee on Drug Dependence (“ECDD”) to conduct evaluations of substances (called “critical reviews”) that form the scientific and medical basis for recommendations to the CND. The CND will next meet in March 2019 to consider WHO’s recommendations.
WHO previously conducted a critical review of CBD at its June 2018 meeting. WHO has also announced that the ECDD will meet between November 12-18, 2018, to conduct a critical review of a number of substances including cannabis. (The ECDD is also conducting a critical review of several synthetic cannabinoids and fentanyl analogues, as well as tramadol and pregabalin.)
First, in regard to CBD, the ECDD has already recommended that pure CBD should not be scheduled within the international drug conventions as it “was not found to have psychoactive properties, and presents no potential for abuse or dependence.” WHO, News Briefing-40th WHO Expert Committee on Drug Dependence (ECDD) (Sept. 13, 2018). This means that WHO will very likely send a recommendation to the CND recommending decontrol of CBD. As previously discussed, DEA rescheduled only FDA-approved drugs containing CBD, a cannabinoid extract from cannabis, with no more than 0.1 percent tetrahydrocannabinols (“THC”) in Schedule V of the Controlled Substances Act. All other CBD formulations remain Schedule I controlled substances. Remember also, that one of the reasons DEA provided for keeping CBD in Schedule V was to comply with the international treaties.
We noted in our October 1, 2018, post that for rescheduling the Epidiolex CBD formulation, DEA sought and received a scheduling evaluation from HHS. We have had the opportunity to review the HHS eight-factor analysis provided to DEA as part of the Epidiolex rescheduling. HHS concluded, based on its scientific and medical eight factor evaluation required by 21 U.S.C. § 811(c), that CBD does not have significant potential for abuse and could be removed from control, but to maintain treaty obligations, recommended that DEA place CBD in the Schedule V, the least restrictive schedule. Department of Health and Human Services, Basis for the Recommendation to Place Cannabidiol in Schedule V of the Controlled Substances Act, 2-3 (May 16, 2018). Thus, the actions by the CND could impact further scheduling of CBD in the U.S.
Second, in regard to cannabis, the June 2018 ECDD conducted a pre-review of:
- Cannabis plant (e.g., marijuana) and cannabis resin (e.g., hashish);
- Extracts and tinctures of cannabis (oils, edibles and liquids);
- THC (e.g., dronabinol); and
- Isomers of THC.
As we asked in our prior post, if CND removes CBD from regulation under the international drug control treaties, will HHS and DEA support descheduling all CBD formulations? Likely more controversial will be what recommendations WHO provides related to cannabis, THC or other extracts and how will the U.S. react to any recommendations to reschedule these substances.
HHS will provide responses to WHO in regard to its solicitation of information related to its review of these substances. Thus, we encourage interested persons to provide comments to HHS through the FDA notice for public comments by October 31, 2018 to ensure that all of the relevant information is included as part of the HHS submission to WHO.
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