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FDA Draft Guidance for Clinical Research of Cannabis and Cannabis-Related Products

On July 21, 2020, the U.S. Food and Drug Administration issued its draft guidance on clinical research for the development of drugs that contain cannabis or cannabis-derived compounds of botanical origin (as opposed to synthetic). The draft guidance isentitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry.”  The guidance provides some clarity on the use of cannabis in clinical research in light of the changes made by The Agriculture Improvement Act of 2018, Public Law 115-334 (the 2018 Farm Bill) which federally legalized hemp and cannabis derivatives that contain no more than 0.3 percent THC on a dry weight basis.  Specifically, the draft guidance outlines the FDA’s “current thinking” on: (1) the source of cannabis and cannabis-derived compounds for clinical research; (2) quality considerations for developing drugs that contain cannabis and cannabis-derived compounds; and (3) how to calculate the THC percentage in botanical raw materials, extracts, and finished products. Source of cannabis and cannabis-derived compounds The draft guidance…

UK Focus: Cannabis-based Drug for Childhood Epilepsy Approved for Use in the UK

Less than one year since medical cannabis was legalised in the UK and just two months since the first medical cannabis clinic opened in London (as reported in our last blog post), a cannabis-based drug has been approved for use in the UK. Its approval may herald the acceptance of cannabis-based drugs into mainstream medicine across the country. What is Epidyolex? Epidyolex is a cannabis-based medicine for children suffering from Epilepsy. Cannabis-based drugs contain cannabidiol (CBD) which is one of the components of marijuana. According to the World Health Organization, “there is no evidence of recreational use of CBD or any public health related problems associated with the use of pure CBD”.   According to publicly available information, Epidyolex contains none of the psycho-active component of cannabis, a compound called tetrahydrocannabinol. The US Food and Drug Administration (FDA) approved Edpidyolexfor use in the US in June 2018. Who is it aimed at? Epidyolex may help individuals suffering from seizures resulting from…

A Cannabis Due Diligence Challenge: Access to Official Records

In recent posts, we discussed lessons learned from recent compliance cases in the cannabis industry, and provided a checklist of key due diligence issues. In both articles, we highlighted the importance of independent verification of state cannabis licenses. Unfortunately, it is not always easy to get official information from state cannabis regulators. Information about cannabis licenses is not always public. This is the case in Arizona, where state law prohibits the release of the names of medical cannabis licensees. In other jurisdictions, license information is usually available, but the presentation of the information ranges from user-friendly databases (California and Colorado) to a series of not-so-user-friendly Excel sheets (Nevada and Oregon). Finally, some state cannabis industries are regulated by more than one agency, which means that verifying licenses may require checking with multiple issuers. For example, California has three different license-issuing regulators. How do states rank on transparency? Galen Diligence has compiled a research guide to accessing official data about cannabis licenses.…

Cannabis Due Diligence II: A Checklist

In a previous post, we discussed lessons drawn from recent compliance challenges in the cannabis industry that highlight some of the consequences that arise without thorough due diligence on cannabis-related business partners (CRB). In this post, we provide a checklist of six key issues to consider when conducting due diligence on partners in the industry. While not intended to be comprehensive, this list is a sound foundation and will help identify areas requiring deeper due diligence. Issue 1: Location of the business In some countries, cannabis is legal for medicinal use. In others, it is legal for medicinal and recreational use. In still others, it carries the death penalty. In the U.S., the law also varies from state to state. Therefore, it is essential to understand exactly where a business is operating – what countries, what states, where it is incorporated, where it operates, where it ships, where it sources – as well as the applicable law in each relevant jurisdiction.…

UN Report Highlights Consequences of Legalization in the U.S.

The United Nations Office on Drugs and Crime (“UNODC”) recently released its 2019 World Drug Report which, among other things, claims that despite legalization in many states of the U.S., illicit markets in the U.S. have continued to thrive, while seizures have decreased and potency and use have increased. As the legalization debate heats up in the U.S., opponents will undoubtedly cite the UNODC findings, while proponents will have to address this data. Therefore, the report warrants close study by all who are interested in the future of marijuana law in the United States. Among other things, the report found that: Although one goal of legalization was to prevent organized crime groups from generating profits from cannabis, thriving illicit cannabis markets still exist in many of the states in the United States that allow non-medical use of cannabis. This is particularly evident in the states of Colorado and Washington, which, in 2012, were among the first jurisdictions in the country to…

What Would Trump’s Re-election Mean for Cannabis Reform?

Given that many of the Democratic Party candidates have expressed support for marijuana legalization, a Democratic victory in 2020 seems likely to increase the chances for significant reform at the federal level. But what about a Republican victory? Although the Republicans have held the White House since 2016, the answer to this question is a mystery, due largely to the inconsistent and constantly shifting views of the President and his administration and the ambiguous positions of key Republican leaders in the Senate. In 2015, while campaigning, Trump characterized Colorado’s law legalizing recreational marijuana as “bad.” Once elected, he appointed as Attorney General Jeff Sessions, who rescinded the Cole Memorandum and committed the Department of Justice to aggressive enforcement of federal narcotics laws, including those against marijuana. However, in June 2018, Trump said that he would “probably” support the STATES Act, which would essentially immunize state-compliant businesses from federal prosecution. Senator Cory Gardner of Colorado, one of the co-sponsors of the STATES…

Contradictions in Cannabis: U.S. Regulatory Landscape at Odds with FDA’s Quest for Data

Cannabis and its derivatives have become a major industry in the U.S. and the U.S. Food and Drug Administration (“FDA”) is coming under increasing pressure to regulate this growing market. As a first step, FDA is on the hunt for data on the safety and efficacy of cannabis and cannabis-derived products. On May 31, 2019 the FDA held a public hearing to “obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.” The problem is that regulatory barriers make it difficult to access raw materials and to perform the research FDA now seeks. Although under pressure to implement regulatory changes, FDA seeks data to ensure that it is taking an appropriate, well-informed, and science-based approach to the regulation of cannabis and cannabis derivatives before doing so. Acting Commissioner, Dr. Norman (“Ned”) Sharpless, opened the May 31 hearing by referring to some of the legal complexities surrounding cannabis: (i) at…

The Democratic Candidates: Where They Stand on Cannabis

Primary season is in full swing, with Democratic candidates crisscrossing Iowa and shaking every hand they can find across New Hampshire. New to this election is the prominence that cannabis legalization and related criminal reform have taken in the major candidates’ platforms. As the country has swung to the left on cannabis legalization, most Democratic politicians have pushed liberalization even further. The candidates have taken varying stances on how exactly to handle cannabis legalization at the federal level, but their positions largely fall into three categories: marijuana use legalization, criminal justice reform, and business regulations to promote cannabis business. Most Democratic candidates are on the record supporting all three categories, but each prioritizes some type of reforms over others. Regardless of their intentions and even if they win the election, a Democratic president will be limited in what reforms he or she can enact. The President will have control over the executive branch and how resources are allocated for cannabis-related enforcement…

Status of Cannabis Legalization in Mexico

Two recent rulings by the Supreme Court of Justice of Mexico (“SCJN”) represent a significant milestone in legal cannabis consumption in Mexico. On October 31, 2018, the First Courtroom of the SCJN, under Minister Norma Lucía Piña Hernández, approved the Amparos en Revisión No. 547/2018 and 548/2018, which declared that the prohibition on recreational cannabis was unconstitutional. These two rulings are binding precedent, which all courts in Mexico must follow when ruling in similar cases. The rulings are ad personam, meaning that individuals seeking a judicial declaration related to cannabis must initiate an action in a competent court to obtain “authorization to consume.” In the same rulings, the SCJN also instructed the COFEPRIS (Federal Commission for the Protection against Sanitary Risk) to authorize the consumption of cannabis, but not the commercialization or consumption of other substances. In response to the rulings, however, the COFEPRIS announced its own position, stating that it lacks the authority to issue the necessary permits and regulations.…

The Long Strange Trip to Regulating CBD in Food

The U.S. Food & Drug Administration (FDA) is under increasing pressure to provide regulatory guidance for using hemp-derived cannabidiol (CBD) in food. Currently, there is no clear route forward, and the FDA rulemaking process will take years. While the recent FDA leadership change will likely complicate the process, FDA is taking the first steps to enact the necessary rules. On December 20, 2018 the Agriculture Improvement Act of 2018, commonly known as the Farm Bill, was signed into law. Among other things, the Farm Bill made changes relating to the production and marketing of hemp and derivatives of cannabis with low (not more than 0.3 %) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes included legalizing hemp (and CBD derived from hemp) by removing it from Schedule I of the Controlled Substances Act. While the Farm Bill removed hemp from the DEA’s purview, it preserved FDA’s authority to regulate it. The very day the Farm Bill became law, then Commissioner…