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In Legislation (Existing)

FDA Draft Guidance for Clinical Research of Cannabis and Cannabis-Related Products

by and 4 Mins Read

On July 21, 2020, the U.S. Food and Drug Administration issued its draft guidance on clinical research for the development of drugs that contain cannabis or cannabis-derived compounds of botanical origin (as opposed to synthetic). The draft guidance isentitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry.”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…

In Other Legal Developments

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

by and 3 Mins Read

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…

In Other Legal Developments

A Cannabis Due Diligence Challenge: Access to Official Records

by 4 Mins Read

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)…

In Government Enforcement

Cannabis Due Diligence II: A Checklist

by and 8 Mins Read

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…

In Other Legal Developments

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

by 4 Mins Read

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…

In Government Enforcement

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

by 5 Mins Read

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…

In Other Legal Developments

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

by 5 Mins Read

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…

In Legislation (Pending)

The Democratic Candidates: Where They Stand on Cannabis

by 6 Mins Read

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…

In Civil Litigation

Status of Cannabis Legalization in Mexico

by 2 Mins Read

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…

In Legislation (Existing)

The Long Strange Trip to Regulating CBD in Food

by 3 Mins Read

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…