American Botanical Council Submits Comments to FDA Suggesting Rescheduling of Cannabis

ABC highlights clinical research supporting therapeutic benefits, noting that current Schedule I status significantly impedes research efforts on cannabis, cannabis preparations, and its compounds

The American Botanical Council (ABC) recently submitted comments to the US Food and Drug Administration (FDA), noting “that more clinical and other research into the medicinal properties of cannabis is warranted, and that the Schedule I status of cannabis is one of the most significant impediments to carry out such research.”¹

ABC’s submission was in response to the FDA’s request for “comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use” of five substances: cannabis plant and resin; extracts and tinctures of cannabis; delta-9-tetrahydrocannabinol (THC); stereoisomers of THC; and cannabidiol (CBD).²

The US Department of Health and Human Services  took the public comments into consideration as it prepared its response to a request for information from the World Health Organization (WHO). According to the FDA, the WHO “will use this information to consider whether to recommend that certain international restrictions be placed on these drugs.”² The WHO conducted a “pre-review” of the evidence submitted by member countries during a special session on cannabis and cannabis-related substances at the 40th meeting of the Expert Committee on Drug Dependence held in June 2018. The WHO is expected to present its final report and recommendations in late July.³

In its comments, ABC emphasized that cannabis’ Schedule I status under the Controlled Substances Act of 1970 is outdated and inappropriate. A Schedule I drug or substance is defined as having “a high potential for abuse,” “no currently accepted medical use in treatment in the United States,” and “a lack of accepted safety for use … under medical supervision.”⁴

“In 1970, when the Controlled Substances Act was enacted, reliable information on the medical value of cannabis was relatively scarce,” ABC noted.¹ “This has changed over the past years, where a number of clinical studies have been carried out to evaluate cannabis, and cannabis isolates, for a variety of conditions and ailments.”

In the comments sent to the FDA, ABC provided short summaries with evidence of the benefits of cannabis, and cannabis fractions enriched in CBD, or THC and CBD, as therapeutic agents in the treatment of pain, multiple sclerosis, and epilepsy. The included data are based on a literature review, which summarized a number of systematic reviews and meta-analyses published between 2015 and 2018. The publications substantiate that cannabis preparations have significant medical benefits.

In June 2018, approximately two months after ABC submitted its comments, the FDA approved the CBD oral solution Epidiolex (GW Pharmaceuticals; Cambridge, United Kingdom) for the treatment of two rare forms of childhood epilepsy. This is the first time the administration has approved a cannabis-derived drug.⁵

ABC concluded: “Based on the promising results from the human studies on cannabis, the current hurdles to investigate cannabis, cannabis extracts, and purified fractions obtained from cannabis ... do not seem appropriate in view of the potential benefits that this plant might provide. Therefore, [ABC] recommends that cannabis be removed from Schedule I [of] the Controlled Substances Act and that other appropriate actions are undertaken to enable more appropriate access of cannabis and its components for medicinal investigations.”¹

A copy of ABC’s comments, which were written by ABC Chief Science Officer Stefan Gafner, PhD, is available at www.herbalgram.org.

—ABC Staff

References

1. Gafner S. American Botanical Council Comments to FDA on Rescheduling of Cannabis Docket No. FDA–2018–N–0181. Austin, TX: American Botanical Council; April 26, 2018.
2. Docket No. FDA–2018–N–1072. International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Cannabis Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9-Tetrahydrocannabinol; Stereoisomers of Tetrahydrocannabinol; Cannabidiol; Request for Comments. April 9, 2018. Federal Register. 2018;83 FR 15155:15155-15157.
3. Fortieth meeting of the Expert Committee on Drug Dependence. World Health Organization website. www.who.int/medicines/access/controlled-substances/ecdd_40_meeting/en/. Accessed July 16, 2018.
4. Title 21 United States Code (USC) Controlled Substances Act: Part B — Authority to Control; Standards and Schedules: §812. Schedules of controlled substances. Drug Enforcement Agency website. www.deadiversion.usdoj.gov/21cfr/21usc/812.htm. Accessed July 16, 2018.
5. FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy [press release]. Silver Spring, MD: US Food and Drug Administration; June 25, 2018.