Tag Archives: recommendation

HHS Recommends Rescheduling Cannabis, Surprising an Entire Industry

By Joshua Weiss, Osiris Morel
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In the most unexpected development to hit the cannabis industry in years, the U.S. Department of Health and Human Services’ (HHS) Secretary Xavier Becerra shared his agency’s recommendation that, based on data and scientific analysis, cannabis, a Schedule I drug under the Controlled Substances Act, should be reclassified as a Schedule III drug. The announcement was made on Wednesday, August 30.

The Background

HHS’ conclusion was sent by letter to the Drug Enforcement Administration (DEA), the agency with authority to reclassify how various substances are treated under federal drug laws. The HHS recommendation means that the nation’s top health agency no longer considers cannabis a drug that lacks medical value and carries the high potential for abuse.

The announcement comes just under a year after President Biden and his administration made a statement on cannabis reform. In that statement, which he made on Oct. 6, the president requested that the Secretary of HHS and the Attorney General (AG) initiate an administrative process to review how cannabis is scheduled under federal law, in addition to pledging to pardon all prior federal offenses of simple cannabis possession, directing the AG to develop an administrative process for the pardons and urging all governors to follow suit for state and local offenses. In a statement, Secretary Becerra said the agency acted “expeditiously” and completed the rescheduling process in less than 11 months, “reflecting the department’s collaboration and leadership to ensure that a comprehensive scientific evaluation be completed.” Indeed, the agency’s announcement reflects the administration’s desire to quickly resolve the country’s failed approach to cannabis reform, as prior rescheduling efforts have taken years. Few thought the federal government would move quickly on cannabis, let alone under a year.

The White House has chosen not to comment on the HHS recommendation as the “administrative process is an independent process led by HHS and DOJ and guided by the evidence.” During a press conference, White House Press Secretary Karine Jean-Pierre reiterated the administration’s position, saying that the administration is taking a more hands-off approach and allowing the federal agencies to determine cannabis’s classification without political influence.

What Does This Mean for the Cannabis Industry?

Although a historic announcement, many industry members hoped for a report that would completely remove cannabis from the CSA. Rescheduling cannabis as a Schedule III drug could provide a route for the FDA to assume a more hands-on regulatory role, and it could open up opportunities for interstate commerce in cannabis. A Schedule III designation does not amount to federal legalization, which means the industry will continue to lack a comprehensive regulatory framework addressing the conflicts between federal and state cannabis laws. Rescheduling cannabis also does not address long-overdue concerns about decriminalization and the effect the war on drugs has had on incarceration rates and racial disparities among the imprisoned.

With the HHS recommendation out in the open and the ball firmly in the DEA’s court, concerns have shifted to the DEA’s timeline for considering rescheduling. No hard deadline exists for the agency to complete its review, and industry stakeholders already know that the rescheduling process can be grueling and lengthy. The last time the DEA rescheduled a drug, hydrocodone combination products (HCPs) in 2004, the process took nearly a decade. In fact, each time the DEA has previously considered rescheduling cannabis, in 2001 and 2006, the process took over two years and resulted in no changes.

While many stakeholders speculate that a decision will be made ahead of the November 2024 presidential election, others remain skeptical given the strict anti-drug posture hardwired into how the DEA operates. In fact, the HHS recommendation coupled with the DEA’s approach to drug policy has led some to speculate that the DEA may compromise by moving cannabis into Schedule II, a category reserved for medicines with high potential for abuse and dependence, including most common opioids.

Either way, the agency’s recommendation is a momentous moment for an industry that has been reeling from falling sales and rising costs. Rescheduling cannabis could open the floodgates to more and better research into cannabis. The Schedule I designation has severely limited scientists’ access to cannabis for research purposes. A Schedule III designation would also have a significant financial impact on cannabis companies that have been deprived of tax deductions and banking services on which most companies depend.

The DEA has confirmed that it received the HHS letter and recommendation and will initiate its five-factor review, which differs from HHS’s eight-factor criteria. It remains to be seen what the DEA will do or when it will be done, but thousands of cannabis companies across the country will be watching closely.

UN Votes to Delay Rescheduling of Cannabis for Second Time in Two Years

By Marguerite Arnold
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For the second time in two years, the United Nations Commission on Narcotic Drugs (CND) has delayed a critical vote on the reclassification of cannabis. The CND met in Vienna, Austria from March 2-6. The vote is now expected to happen in December 2020. The discussion about reclassification of the plant, however, has been going on for a little longer than that.

WHO Recommendations

There are several recommendations that are on the table (even if far from perfect). See the full text of the recommendation here.

  1. Delta 9 Tetrahydrocannabinol should be added to Schedule I of the 1961 Single Convention on Narcotic Drugs.
  2. Delta 9 Tetrahydrocannabinol should be removed from the 1971 Convention on Psychotropic Substances.
  3. The six isomers of tetrahydrocannabinol chemically similar to Delta 9 THC should be classified similarly to Delta 9.
  4. Extracts and tinctures made from cannabis should be removed from Schedule I of the 1961 Single Convention but that they should also be classified per the act. In other words, extracts with THC should be considered narcotics with medical purpose and all dealt with per a single rule.
  5. Cannabidiol products containing no more than 0.2% of Delta 9 THC should not be under international control.
  6. Preparations with THC that are made as pharmaceutical products should be reclassified as Schedule III drugs per the 1961 Convention. (Note – Dronabinol is already classified this way in the United States and has been since 2010).

What Does This Really Mean?

Given the impending lockdown of whole industries right now, but a wartime footing for certain pharmaceutical drugs and medical equipment makers, on one hand, this seems like the obvious and safest thing to do. The world needs a vaccine and direct treatments and to focus research, manpower and money in that direction.

Further, and this should hopefully galvanize the industry internationally, what this also does is keep the consumption of the plant itself basically illegal while putting the focus on professionally prepared pharmaceutical drugs.

This is short-sighted. Cannabis is unlike other medications. Further, the high cost of pharmaceutical drugs makes wider treatment policy options extremely expensive to implement.

Further, this approach continues to define cannabis – specifically Delta 9 and THC – as a narcotic.

While it is undeniably true that for recreational users, there are narcotic effects, most long term patients do not react to the drug this way – particularly if they suffer from chronic pain due to neurological issues (including movement disorders), inflammatory diseases like rheumatoid arthritis and those that destroy the body’s immune response, like HIV.

There is a need for regulation, normalization of supply chains globally and of course, medical trials.The definitions of this plant, in other words, need to change. And not just for the benefit of pharmaceutical companies, but for patients as well.

Further, in a world that is quickly headed for a global recession unseen since the Great Depression, highly priced medications are not the best Rx.

As the German government responded to President Donald Trump recently, as he tried to offer a German company a billion dollars to only develop a vaccine for use on Americans, there are clearly limits to capitalism.

The Good News

It is highly unlikely by December, nine months into a global public health crisis which is widely expected to last for at least the next two years, that the UN will delay the vote again come December. There is a need for regulation, normalization of supply chains globally and of course, medical trials.

Beyond that, recreational reform also looms at a federal level in many countries and regions.

However, given the discussions so far, it is also clear that beyond the redefinition of cannabis, there will be greater legal opportunities to expand an industry too long stigmatized by old fashioned understandings and definitions of what cannabinoids are.

Coronavirus Guidelines for the Cannabis Industry

By Aaron Green
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The World Health Organization (WHO) recently recognized COVID-19, the disease caused by the coronavirus SARS-CoV-2, a pandemic. What can cannabis businesses do to help reduce transmission?

At the time of this writing, community transmission of COVID-19 has been observed in every continent except Antarctica. While China and South Korea are showing signs of containment, with negative disease growth rates, the rest of world is experiencing positive – and in some cases exponential – disease growth rates. Many companies in the cannabis industry are asking: what can we do to slow the spread of the virus and get ahead of the outbreak?

By adopting sensible policies, businesses play a key role in reducing disease transmission. On March 13, 2020, The International Chamber of Commerce (ICC), in collaboration with the WHO and New England Complex Systems Institute (NECSI), released Coronavirus Guidelines for Business, a summary of actions businesses can take to reduce immediate risks to employees and long-term risks to costs and profitability. The guidelines have since been delivered to more than 45 million businesses worldwide.

There are four sections to the guidelines:

  • General Recommendations
  • Meetings, Travel and Visitors
  • Workplaces
  • Retail and Hospitality

Specific recommendations relevant to the cannabis industry include working remotely where possible, avoiding unnecessary travel and keeping clear records of each day’s contacts. Where possible, a pick-up and drop-off service, home delivery or drive by services are recommended.

Businesses should be developing, readying and implementing business continuity plans based on the ICC guidelines. At this point, a conservative position would be to assume that if an outbreak has not been reported locally it is only a matter of time before local cases are reported. Specific actions businesses should take will depend on location, nature of the workplace and potential disruptiveness to operations.

The ICC and NECSI Coronavirus Guidelines for Business can be found here.

endCoronavirus.org is built and maintained by NECSI and its collaborators and specializes in networks, agent-based modeling, multi-scale analysis and complexity as it relates to COVID-19.

The International Chamber of Commerce (ICC) is the institutional representative of more than 45 million companies in over 100 countries. ICC’s core mission is to make business work for everyone, every day, everywhere. Through a unique mix of advocacy, solutions and standard setting, they promote international trade, responsible business conduct and a global outreach to regulation, in addition to providing market-leading dispute resolution services. Their members include many of the world’s leading companies, SMEs, business associations and local chambers of commerce.

The New England Complex Systems Institute (NECSI) is an independent academic research and educational institution with students, postdoctoral fellows and faculty. In addition to the in-house research team, NECSI has co-faculty, students and affiliates from MIT, Harvard, Brandeis and other universities nationally and internationally.

Going Beyond the Strain Names with PotBot

By Aaron G. Biros
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PotBot kioskDavid Goldstein, co-founder and chief executive officer of PotBotics, launched a medical cannabis recommendation engine called PotBot with the goal to better inform patients to target their conditions with more accurate recommendations based on scientific research. “This is a tool to help move the market away from the thousands of strain names that are mainly just marketing or branding indicators,” says Goldstein. The medical application is designed to inform patients on peer-reviewed data, research on the treatment of their ailments with cannabis and the specific cannabinoids that are necessary for treating their condition. They began development on PotBot in October of 2014, launching the beta version to 400 users in November of 2015. On April 20th, 2016, Goldstein launched officially in the Apple Store, and the program will be available on Android in July.

goldstein potbot
David Goldstein (left) alongside co-founder, Baruch Goldstein (right)

Rather than focusing on strain names, PotBot focuses on the cannabinoid values to help patients gain an understanding of the correlation between which compounds might best target their condition. “This is a great tool for patients trying to familiarize themselves with what strains might work best,” says Goldstein. “For example, insomnia patients generally need cannabis with higher CBN levels, so we first educate the patient on cannabinoid ranges to shoot for and what strains might help. PotBot would recommend the strain Purple Urple because it is an indica found to have higher CBN values,” adds Goldstein. The program goes into great detail with the patient’s preferences including everything down to consumption methods so they know why it might recommend certain strains.

A screenshot showing a recommended cannabinoid ratio for a patient
A screenshot showing a recommended cannabinoid ratio for a patient

The recommendation tool is accessible via kiosks at dispensaries, on a desktop version for the computer as well as on the Apple Store for iPads and iPhones. “I do not see it as a way of replacing budtenders, rather supplementing them with knowledge,” says Goldstein. PotBot is designed as a tool to supplement the budtender’s understanding of cannabis, so the budtender does not need to know everything off the top of their head or recommend strains based on anecdotal information, according to Goldstein.rsz_potbot_kiosk

Goldstein’s team at PotBotics performed extensive research prior to launching PotBot, spending two years doing strain testing to develop the program. “There is currently no regulatory body [for strain classification] so we took it upon ourselves to work with the best testing laboratories for truly robust analyses and properly vetted growers to get the most valid data,” says Goldstein. “The current strain classification system and nomenclature is rather unscientific so we focus on cannabinoid values and soon we will be able to incorporate terpene profiles in the recommendation.” Moving away from the common focus on taste, smell and other qualitative values, they focus on medical attributes of cannabinoid profiles because they have the most peer-reviewed research available today.

As an OEM, the company designed the tool to work with each dispensary’s inventory, to provide recommendations for strains that a patient can access on site, however anyone can access the recommendation tool for free at PotBot.com. Goldstein’s company and their mission represent an important development in the cannabis industry; this could begin a key transition from thousands of understudied strain names to a more scientific and calculated method to treating patients’ conditions with cannabis.