International health experts are putting a closer eye on how cannabis and its compounds such as cannabidiol should be regulated.
As the World Health Organization (WHO) begins an examination into what level of international controls could be implemented on CBD, advocates for legalization of the cannabis compound have spotted an opportunity. They’ve submitted public comments in droves to extol the potential medicinal properties of CBD — a compound that’s enshrouded by legal and regulatory uncertainty.
The U.S. Food and Drug Administration solicited public input on CBD and 16 other drug substances – including ketamine and synthetic opioids — in advance of the 39th meeting of WHO’s Expert Committee on Drug Dependence (ECDD). The committee convenes in Geneva, Switzerland, from Nov. 6 to 10 to review the substances and begin work on potential recommendations to the United Nations Secretary-General.
The November meeting is an early step in a long process that may define how CBD is regarded and controlled internationally.
The United States Hemp Roundtable — the entity behind the saveourcbd.com website, formed to drum up support and written comments — joined several thousand public comments submitted to the FDA. The organization of businesses that make hemp-derived, CBD-rich products claimed that the cannabis compound should not be shepherded solely to the realm of pharmaceuticals.
“The structure and nature of the FDA forces definition into food, drug and supplements and the grey area of all the other products not classified,” Brian Furnish, the U.S. Hemp Roundtable’s president, wrote in a letter submitted as part of the public comment process. “CBD produced from hemp is not a controlled substance, so it is clearly not a drug. The FDA, with antiquated rules that only benefit pharmaceutical companies, says that CBD is not a supplement.
“That means CBD derived from hemp is food.”
As the public comment period was starting to draw to a close on Wednesday, more than 6,400 comments had been submitted — the vast majority of which were about CBD, according to The Cannabist’s review. More than 1,000 comments were pre-written responses suggested by saveourcbd.com, The Cannabist found.
Whether those comments are heard or acted upon by international experts remains to be seen.
The comments will first be considered by U.S. Health & Human Services, which is expected to provide its input on the 17 substances by filling out a questionnaire on aspects such as medical use, scientific use, current control status, misuse, and cultural or religious use.
However, HHS will hold off on making recommendations of its own until WHO’s determinations are submitted to the Commission on Narcotic Drugs — an action expected early next year, FDA officials disclosed in Federal Register documents..
HHS will then come back for another round of public comments before providing its position on international control of the substances.
Early stage work
WHO’s examination of CBD is a long play that has been years in the making.
At their annual meetings in 2016 and 2015, ECDD members requested further evaluation of the cannabis plant and its components. Last year, the committee set an 18-month timetable to receive additional information and evidence to continue evaluation of cannabis, cannabis extracts and tinctures, delta-9 tetrahydrocannabinol, CBD and THC stereoisomers within the bounds of international drug control policy.
“The committee recognized: An increase in the use of cannabis and its components for medical purposes; the emergence of new cannabis-related pharmaceutical preparations for therapeutic use; cannabis has never been subject to a formal pre-review or critical review by the ECDD,” WHO’s Director-General wrote in the Nov. 25, 2016, recommendations letter.
The committee recommended that the pre-reviews be evaluated over the following 18 months.
From there, a determination would be made as to whether the information justifies an “Expert Committee critical review,” officers for the ECDD Secretariat told The Cannabist earlier this year. The pre-review is preliminary and findings would not determine a change in control status, ECDD officials said.
A progress report of that work is scheduled to be given at the upcoming ECDD meeting, along with the pre-review for CBD, meeting agendas show.
The vast majority of the 17 substances under discussion at the ECDD meeting are among WHO’s “Substances Under Surveillance” list, which includes substances that have the “potential to cause public health harm.” The public health risks for many of those substances were disclosed in their descriptions outlined in the ECDD meeting documents and the FDA’s request for public comment.
CBD, however, is not under surveillance and its description in the documents cites potential medical benefit versus potential public harm:
Cannabidiol (CBD) is one of the active cannabinoids identified in cannabis. CBD has been shown to be beneficial in experimental models of several neurological disorders, including those of seizure and epilepsy. In the United States, CBD-containing products are in human clinical testing in three therapeutic areas, but no such products are approved by FDA for marketing for medical purposes in the United States. CBD is a Schedule I controlled substance under the CSA. At the 37th (2015) meeting of the ECDD, the committee requested that the Secretariat prepare relevant documentation to conduct pre-reviews for several substances, including CBD.
Research at risk
Closely watching the activity in Geneva this November will be American researchers who lament the restrictive barriers to studying cannabis and components such as CBD.
The compound is on lockdown because of its Schedule I status, said Heike Newman, a senior regulatory manager at the University of Colorado’s Anschutz Medical Campus.
Newman’s job there includes providing assistance to clinical researchers when they need to submit investigational new drug applications to the FDA for further research of an unapproved drug or an approved drug for a different condition.
Nearly three years ago, Newman assisted two of the school’s clinicians with the paperwork and implementation of the first-ever approved Schedule I studies at the University of Colorado-Denver.
The process has been fascinating in that it’s quite pioneering, she said. But being early movers comes with a fair share of ground to break.
To research CBD requires a Schedule I license; to provide CBD for research requires a Schedule I license.
“Once you have the Schedule I license … then the manufacturer probably doesn’t have Schedule I facilities,” she said. “You’re constantly bumping into a problem.”
Cannabidiol is not listed explicitly as a controlled substance in the 1961 United Nations’ Single Convention on Narcotic Drugs or the 1972 Protocol amending the Single Convention.
However, the international body lists the cannabis plant and cannabis resin as Schedule I and Schedule IV substances — the two most-restrictive categories. Cannabis extracts and cannabis tinctures are also listed solely as Schedule I, which does account for therapeutic potential.
Late last year, the U.S. Drug Enforcement Agency issued a rule notice about the establishment of a drug code for marijuana extracts. The code addition primarily was an administrative move, DEA officials said, citing it would allow them to better track research requests and comply with the Single Convention treaties.
In the notice and subsequent disclosures and interview, the DEA asserted CBD’s ongoing Schedule I status, spurring fear and confusion among producers and consumers alike and triggering a lawsuit from hemp industry members.
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