FDA officials have put out a call for public comment about the potential rescheduling of cannabis and several other substances.

Summary

The Food and Drug Administration (FDA) is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 16 drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (the CSA).

Cannabis, also known as marijuana, is a plant known by biological names Cannabis sativa or Cannabis indica. It is a complex plant substance containing multiple cannabinoids and other compounds, including the psychoactive chemical THC and other structurally similar compounds. Cannabinoids are defined as having activity at cannabinoid 1 and 2 (CB1 and CB2 respectively) receptors. Agonists of CB1 receptors are widely abused and are known to modulate motor coordination, memory processing, pain, and inflammation, and have anxiolytic effects.

The principal cannabinoids in the cannabis plant include THC, cannabidiol (CBD), and cannabinol. These substances are controlled in Schedule I under the CSA. The synthetically derived single pure stereoisomer, (−)-trans-delta-9-THC (also known as dronabinol) is the active ingredient in two approved drug products in the United States, MARINOL (dronabinol) capsules (and generics) and SYNDROS (dronabinol) oral solution. MARINOL is controlled in Schedule III, while SYNDROS is controlled in Schedule II under the CSA. Both MARINOL and SYNDROS are approved to treat anorexia associated with weight loss in patients with acquired immunodeficiency syndrome (AIDS), and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional treatment.

CBD is another cannabinoid constituent of the cannabis plant. In the United States, one CBD-containing product, Epidiolex oral solution, has received marketing approval by FDA for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients 2 years of age and older. The CBD in Epidiolex is extracted and purified from the cannabis plant. Currently, CBD is controlled generally as a Schedule I substance under the CSA. However, the recent scheduling action on September 28, 2018, by the DEA for Epidiolex, and any future, similar formulations of CBD that become FDA-approved medications, places these FDA-approved CBD formulations in Schedule V under the CSA. ⁽¹⁾ CBD is not specifically listed in the schedules of the 1961, 1971, or 1988 International Drug Control conventions.

At the 40th (2018) meeting of the ECDD, the committee critically-reviewed CBD and pre-reviews of cannabis plant and resin; extracts and tinctures of cannabis; THC; and isomers of THC. The 40th ECDD recommended that preparations considered to be pure CBD should not be scheduled within the International Drug Control Conventions, and that cannabis plant and resin; extracts and tinctures of cannabis; THC; and isomers of THC proceed to a Critical Review.

All comment submissions are due by October 31 — submissions can be made online via the FDA website or written statements can be mailed to the agency.

The comment period was prompted by a call from the World Health Organization (WHO) for input regarding drug laws and potentially updating international drug treaties that bar nations from legalizing certain drugs — treaties that were championed by the U.S. government during the heyday of the drug war. Uruguay and Canada have both taken steps to federally legalizecannabis but, so far, the international community has not taken significant action against them.

Last week, reports surfaced that the FDA had called for the complete descheduling of CBD — the non-psychoactive cannabinoid most commonly associated with pain relief and epilepsy medication — but DEA pushback resulted in a Schedule 5 classification for only FDA-approved drugs.

Looking to understand the state by state requirements for security and surveillance for Cannabis operations? Read the Report