CBD on the international stage: WHO committee delving into science, control status of cannabis compound

Cannabist Special Report: CBD, TBD -- American advocates for hemp and CBD oil hope their pleas to the FDA will have a global ripple effect

Cannabidiol is a non-psychoactive cannabis compound touted for its medicinal promise — but marijuana- and hemp-derived extracts rich in CBD and low in intoxicating THC are facing a future yet to be determined.

The Cannabist’s special report “CBD, TBD” explores a regulatory and legal landscape pockmarked by federal-state conflicts, and examines national drug policy, pioneering research efforts and disparate avenues toward the compound’s full legalization. This is the fifth installment in an ongoing series.

Part I – Forbidden medicine: Caught between a doctor’s CBD advice and federal laws

Part II – How advocates are inspiring congressional action on CBD legalization

Part III – With DEA digging in its heels on “marijuana extracts,” legality of CBD oil on trial in federal courts

Part IV – CBD research is going to the dogs in quest to legitimize pet products


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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Can Nevada casinos cash in on cannabis industry without breaking federal law?

The gaming industry has numerous questions including whether casino-resorts can host marijuana-related conventions

LAS VEGAS — Nevada Gov. Brian Sandoval on Wednesday ordered a committee to make policy recommendations on the interactions between the state’s long-established gambling industry and a budding, yet exceedingly popular one: recreational marijuana.

The executive order Sandoval signed calls on the Nevada Gaming Policy Committee, which includes gambling regulators, casino representatives and others, to address a series of issues, including whether events catering to or promoting the marijuana industry can be held on the premises of a casino-resort.

The committee is expected to meet no later than Dec. 15.

“Gaming regulators have been clear on the prohibition of marijuana consumption on licensed gaming properties but there are additional policy considerations such as industry events and business relationships that should be contemplated,” Sandoval said in a statement.

Nevada launched legal sales of recreational cannabis on July 1. There’s been heavy demand from tourists, but the law only allows marijuana consumption in private homes. It’s prohibited in casinos, bars, restaurants, parks, concerts and on any federal property.

Licensed gambling businesses in the state cannot violate federal law. Doing so can get them in trouble with the state’s gambling regulators. So, gambling regulators have been clear: As long as marijuana remains illegal under federal law, licensees are not to be a part of the cannabis industry.

A.G. Burnett, chairman of the Gaming Control Board and a policy committee member, said the gambling industry has numerous questions outside direct engagement with cannabis businesses, including whether casino-resorts can host marijuana-related conventions, as well as ways in which cash proceeds from marijuana transactions can find their way to casinos.

“So, even if marijuana isn’t used, is it appropriate to host a convention where bongs and pipes are being sold?” Burnett said. “And there are other questions, too. Any money that comes out of something illegal, when it is transferred to buy something, it’s considered money laundering … What if the patron gambles with that cash and the casino knows?”

In November, the Marijuana Business Conference and Expo, which is expected to draw more than 650 exhibitors, will take place at the Las Vegas Convention Center near the Las Vegas Strip.

The policy committee is also expected to address whether casinos can receive or provide financing to a person or business that sells, cultivates or distributes the drug.

Sandoval, a Republican former federal judge, initially opposed legalization of recreational marijuana that voters approved in November but said he accepted the will of the people and pushed an early sale program to expedite collection of revenue from state cannabis taxes.

He ordered the policy committee to make recommendations by June.

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New York will allow medical cannabis chewables, fizzy tablets and topicals

Other changes include a short training program for doctors

ALBANY, N.Y. — New York state is making more changes to its medical marijuana program.

Health officials announced new regulations Thursday that will permit new forms of the drug, including chewable and effervescent tablets and lozenges as well as topical lotions, ointments and patches.

The state also plans to create a new, shorter training program for physicians interested in authorizing medical marijuana for patients.

New York has one of the nation’s more conservative medical cannabis programs, and smokeable marijuana still isn’t allowed. But officials say they’re continuing to look for ways to tinker with the rules to make it easier for patients to get the help they need.



The new regulations are expected to take effect next month.

As of Tuesday there were 26,561 patients authorized to obtain medical marijuana in the state.

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Colorado marijuana sales top $750 million at 2017 midpoint

Cannabis sales through June 2017 are up 25.7 percent compared with the first half of 2016, The Cannabist's calculations show.

Halfway through 2017, Colorado’s marijuana retailers amassed more than $750 million in sales, according to The Cannabist’s extrapolations of the latest tax data released by the state.

Covering both the medical and adult-use markets, the sales of flower, edibles and concentrates through June 2017 are up 25.7 percent compared with the first half of 2016, The Cannabist’s calculations show.

The cumulative sales made through June equate to nearly $116 million in tax revenue and license fees for the state.

The Colorado Department of Revenue on Thursday published the report for marijuana sales and excise taxes remitted in July. The receipts largely reflect sales made in June, but could include some variance based on incomplete or late returns from prior months.

Barring any major variance in returns, June appears to have been a near-record month for Colorado’s marijuana shops, with $131.65 million in total sales. That would trail the high of $131.69 million set earlier this year in March, but extends the streak of $100 million monthly sales to 13 months.

Adult-use transactions accounted for $95.54 million, or more than 72 percent, of June’s sales. The $36.11 million of medical marijuana products sold remains in line with the monthly averages for 2016 and 2017.

As Colorado’s marijuana industry continues to mature, the annual growth rates are expected to slowly ratchet down, analysts have said.

Bethany Gomez, director of research for cannabis market research firm Brightfield Group, told The Cannabist last month:

“What you’re seeing in Colorado is similar to other industries, we’re starting to see lower double-digit growth rates, rather than the triple-digit growth rates.

“That time of massive growth expansion in Colorado, I think, is over.”



 

Sales stats for Colorado weed
A month-by-month look comparing sales of recreational and medical marijuana, as calculated by The Cannabist:
 

 

2017 Recreational total (6 months)
$531,616,125
2017 Medical total (6 months)
$219,657,419
2017: $751,273,544
2016 Recreational total (12 months)
$875,277,360
2016 Medical total (12 months)
$437,879,186
2016: $1,313,156,545

 


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Big change: Nevada to start handing out weed distribution licenses beyond liquor wholesalers


CARSON CITY, Nev. — Nevada’s marijuana regulators have decided to start issuing cannabis distribution licenses to businesses other than liquor wholesalers to keep up with overwhelming demand since legal recreational sales began July 1.

The Nevada Department of Taxation voted Thursday to open up the market previously limited to liquor distributors under the state ballot measure voters approved in November.

Department spokeswoman Stephanie Klapstein said they’ll begin reviewing about 80 applications they received in May from other businesses.

Tax officials previously tried to open the distribution process to medical dispensaries, but liquor wholesalers argued in court that violated state law.

A Carson City judge sided with the wholesalers, saying the state needed to establish formal criteria to determine if there aren’t enough distributors to do the job.

The state tax commission approved an emergency regulation last month intended to meet the judge’s concerns.

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