The Food and Drug Administration (FDA) is accepting comments to help formulate the United States’ position on the World Health Organization’s recommendations on certain drug substances, including cannabis extracts and cannabidiol (CBD), in preparation of a meeting of the United Nations Commission on Narcotic Drugs (Commission) to be held on March 2018.
In November 2017, after the WHO Expert Committee for Drug Dependence (Expert Committee) met, the Expert Committee issued its recommendations for scheduling various substances under international control, pursuant to international treaties such as the 1971 Convention on Psychotropic Substances (1971 Convention) and the 1961 Single Convention on Narcotic Drugs (1961 Convention). The Expert Committee did not include CBD among those substances, stating instead that “there is no evidence that CBD as a substance is liable to similar abuse and similar ill-effects as substances in 1961 or 1971 Conventions.” The Expert Committee concluded that the current information does not justify scheduling of CBD.
The Expert Committee went on, however, to note that CBD is produced for pharmaceutical purposes as an extract of cannabis, and cannabis extracts and tinctures are included in the 1961 Convention. In that regard, cannabis extracts are listed in Schedule I of the 1961 Convention which contains drugs subject to the least stringent controls, unlike Schedule I of the US Controlled Substances Act (CSA) which contains substances subject to the most stringent controls. The requirements for substances identified on Schedule I of the 1961 Convention, such as cannabis extracts, include import and export authorization, licensing of manufacturers/ distributors, recordkeeping requirements, medical use prescriptions, annual estimates of needs, quotas and statistical reporting, and limitations on use for medical and scientific purposes. As part of its recommendations report, the Expert Committee advised that it will conduct a pre-review of cannabis extracts and tinctures at its next meeting in May 2018, and it recommend that it also carry out at that meeting a critical review of cannabis extracts and preparations that contain almost exclusively CBD.
Characterization of cannabis extracts including CBD has been the source of significant controversy in the US cannabis industry, particularly after the US Drug Enforcement Administration (DEA) established a new drug code for marijuana extracts. In December 2017, the DEA published a final rule establishing a new controlled substance code number (7350) for marijuana extracts. According to the DEA, the purpose of the new code was to allow the DEA to track quantities of the extracts imported and exported from the US in order to better comply with the 1961 and 1971 Conventions. Subsequent to the publication of the DEA rule, the DEA received numerous questions regarding the inclusion in the new code of an extract containing only CBD. The DEA clarified that the new drug code would not apply to a product that contained CBD as long as it consisted only of the parts of the cannabis plant that was excluded from the CSA definition of marijuana, such as seeds and stalk. It, nevertheless, was skeptical of the notion that extracts containing cannabinoids, including CBD, are produced using only the excluded parts of the plant. Moreover, it cautioned that if an extract were produced from resin, even from resin from the excluded parts of the plant (which is where it believes cannabinoids may be found in trace amounts – resin sticking on seeds and stalk), such an extract would be subject to the drug code since resin is an exception to the excluded parts.
With regard to the current call for comments, pursuant to the provisions of the international conventions, the UN Secretary-General notified the US regarding the Expert Committee’s recommendations resulting from its November 2017 meeting, and has requested that the US communicate “any economic, social, legal, administrative or other factors that it considers relevant to” the possible scheduling of various substances recommended by the Expert Committee to be placed under international control. In connection therewith, the FDA, through its announcement published today in the Federal Register (FDA-2018-N-0181), is requesting comments on the Expert Committee’s scheduling recommendations which it will consider together with the National Institute on Drug Abuse in evaluating the recommendations in preparation of the Commission’s meeting.
Again, at this stage the WHO’s Expert Committee has not recommended that CBD be placed on the international treaty schedule, and is instead planning to conduct a pre-review of cannabis extracts (which are scheduled under the international treaties) and a critical review of cannabis extracts containing solely CBD at its next meeting in May. These reviews, however, will form the basis of the Expert Committee’s recommendations regarding scheduling, if at all, of the substances under international controls. As such, it would behoove the cannabis industry to pay close attention to these proceedings at the FDA level and the WHO level given the DEA’s position and prior statements made in relation to marijuana extracts and CBD.