Federal Court Affirms Crackdown on Intoxicating Substances Synthesized from Hemp

In the absence of federal enforcement action, state legislatures have stepped into the breach, enacting laws regulating products containing intoxicating  substances that are chemically synthesized versions of chemicals in hemp. Those substances are referred to here as hemp-synthesized intoxicants or HSIs.  Challenges to state authority to regulate HSI are being filed. In a recent decision that may foreshadow what is to come, a federal court declined to enjoin Wyoming’s hemp law.

As we have previously reported, the passage of the Agriculture Improvement Act, commonly referred to as the 2018 Farm Bill, opened the floodgates to unregulated intoxicating hemp products across the country. Though the 2018 Farm Bill authorized the U.S. Food and Drug Administration to regulate hemp-derived products intended for human consumption, the FDA has yet to promulgate rules for such products or HSIs. In the absence of federal regulations, states have begun to enact their own rules.

In Green Room LLC, et al. v. State of Wyoming, et al., a group of HSI wholesalers, retailers, and manufacturers filed a federal suit challenging amendments to Wyoming’s hemp laws and requesting a preliminary injunction. In pertinent part, the amendments expanded the definition of THC to include any psychoactive structural, optical, or geometric isomers of THC, encompassing both CBD and the popular Delta-8 THC. Because cannabis remains illegal in Wyoming, the amendments effectively prohibited the possession, sale, transport, and production of intoxicating substances synthesized from hemp. The plaintiffs argued, in part, that the amendments were unconstitutional because they were preempted by the 2018 Farm Bill, which they claim legalized all hemp substances, including intoxicating substances synthesized from hemp, for intrastate and interstate purposes.

On July 19, 2024, the federal court denied plaintiffs’ request to enjoin enforcement of the new law, finding that they do not have a substantial likelihood of success on the merits.

Specifically, the court found that the 2018 Farm Bill does not prevent states from regulating HSIs. The court found the 2018 Farm Bill did not confer any right on plaintiffs to manufacture or sell intoxicating products resulting from hemp, but merely redefined the term hemp. Most important, it held the 2018 Farm Bill contains an express “no preemption” clause permitting states to regulate hemp more stringently than federal law. The no preemption clause expressly permits a state to enact laws regulating intoxicating substances synthesized from hemp in a manner “more stringent” than the 2018 Farm Bill.  The court further concluded that Wyoming’s amendments do not violate the dormant commerce clause, do not amount to a regulatory taking, and are not unconstitutionally vague or overbroad.

Green Room is not the first challenge to state restrictions on HSIs.  In Bio Gen LLC et al. v. Sanders et al., the State of Arkansas appealed a trial court decision enjoining Arkansas regulations that restrict the manufacture and distribution of products that contain synthetic cannabinoids that could be intoxicating, such as Delta-8 THC.  In Northern Virginia Hemp and Agriculture LLC, et al. v. Commonwealth of Virginia, et al., the plaintiffs, an HSI product manufacturer/distributor and consumer, appealed a trial court decision that denied their motion to enjoin the State of Virginia from enforcing Virginia regulations that restrict the manufacture and distribution of products that contain synthetic cannabinoids that could be intoxicating, such as Delta-8 THC.

Those pending appeals present the possibility of a federal circuit split on the question whether the 2018 Farm Bill legalized intoxicating substances that could be derived from hemp.  On behalf of the American Trade Association for Cannabis & Hemp, Duane Morris filed an amicus brief in each case that asserts that the 2018 Farm Bill did not legalize hemp-synthesized intoxicants, and it reserved for states the right to regulate such substances in the interest of public safety.

As more states roll out new restrictions on intoxicating hemp products and operators, we expect to see more challenges. Though not a final ruling on the merits of the suit, the court’s decision suggests these plaintiffs and others challenging state intoxicating hemp laws have an uphill battle ahead.

Cannabis Highlights in the NBA’s New Collective Bargaining Agreement

On April 26, 2023, the National Basketball Association (NBA) announced the ratification of its new, seven-year Collective Bargaining Agreement (CBA) with the National Basketball Players Association (NBPA).  The CBA will take effect on July 1, 2023, and will run through the 2029-30 season.  The CBA provides, among other things, certain key changes to cannabis-related matters, particularly in connection with the NBA’s Anti-Drug Program and NBA players’ business opportunities.

Anti-Drug Program

According to a summary of the agreement as reported by Law360, the NBA decided to remove cannabis from its Prohibited Substances List.  However, NBA players are still subject to random drug tests.  The NBA has authority to conduct up to 1,925 random urine tests each season.  In addition, teams may refer players to a treatment program if they suspect them of (1) being under the influence of cannabis while participating in league activities, or (2) experiencing a dependency on cannabis.

Furthermore, the NBA may still discipline players for violating the law or for being under the influence during league or team activities.  Players who neglect or fail to comply with the Anti-Drug Program will be banned from league activity.  Nevertheless, players may now apply for reinstatement of eligibility after one year, as opposed to the two-year rule enforced since 1983.

Business Opportunities

NBA players are also now permitted to: (1) invest in companies that make CBD-infused products, and (2) hold a passive, non-controlling interest in companies that make products with more substantial concentrations of THC.  Although players may now promote companies that make CBD-infused products, the NBA continues to prohibit players from promoting cannabis companies and marijuana products.

Chicago Cubs Partner with CBD Beverage Company Under New MLB Sponsorship Rules

On April 7, 2023, the Chicago Cubs announced a partnership with MYND DRINKS, a Chicago-based cannabis beverage company.  This historic partnership recognizes the Cubs as the first Major League Baseball (MLB) team to collaborate on a business venture with a cannabis company.

Background

Back in December 2019, MLB modified its list of abusive drugs by removing cannabis to implement a more treatment-based approach.  The league’s updated drug policy allows players to use natural cannabinoids for medical purposes, such as to help relieve pain, improve quality of sleep, and manage stress or anxiety.

A couple years later, on June 22, 2022, MLB announced a landmark decision to approve CBD sponsorships.  However, the sponsorships must satisfy two requirements:

  1. CBD companies must receive the NSF Certified for Sport® designation, a certification designed to:
    1. favor products infused with CBD, a non-psychoactive compound found within the hemp plant, and
    2. disfavor products infused with psychoactive levels of THC, which pose a risk of drug-induced sensations to consumers, and
  2. MLB teams must receive approval from the Commissioner’s office.

MYND DRINKS produces 100% plant-based, CBD-infused, sparkling beverages.  The three beverage flavors—Lemon Ginger, Elderberry Passionfruit, and Orange Mango—each satisfied MLB’s safety measures to obtain NSF certification.  The CBD company promotes wellness and recovery, and aspires to change the world “one MYND at a time.”

Partnership & Opportunities

The partnership between the Cubs and MYND DRINKS includes, among other things, on-field signage at Wrigley Field stadium, certain in-game features, and international marketing rights in the United Kingdom.

Furthermore, MLB’s Chief Revenue Officer stated that the league is open to featuring jersey patch sponsorships for the 2023 season.  Since opening day, on March 31, 2023, a handful of MLB teams debuted sponsorships with a company logo adorned on the sleeve of players’ jerseys.  Cannabis companies are permitted to participate in such deals as well.  However, a company interested in this arrangement must “have a brand that represents sports.”  CBD brands supporting wellness and recovery, like MYND DRINKS, will likely receive a green light from the league’s administration.

Cannabis Market Trends 

Market competition is intensifying due to the increasing therapeutic properties of cannabis and continuing legalization of markets.  As a result, there has been a rise in demand for cannabis-infused beverages, edibles, and other related products.  The global cannabis market was valued at about $13 billion in 2022 and is projected to grow at a compound annual growth rate of 22% to reach over $66 billion by the end of the decade.  Cannabis companies are thus eager to establish a position in this rapidly expanding market.

Therefore, this CBD partnership will be revolutionary for MLB and other professional sports leagues across the globe.

Read the full text of the article on Law360.

“Professional Sports & CBD” Webinar Replay Available

A video replay of the webinar “Professional Sports & CBD: The Journey Ahead,” featuring NBA Hall of Famer Dominique Wilkins, is available to view.

Duane Morris Partners Named to ATACH CBD Task Force

Duane Morris partners Seth Goldberg and David Landau have been named to the American Trade Association for Cannabis and Hemp (ATACH) Task Force, which will focus on the harmonization of laws and regulations that contribute to the bifurcated treatment of hemp and marijuana, as well as the evolving regulatory landscape for cannabis industry participants. Mr. Goldberg, a team lead for the Duane Morris Cannabis Industry Group, joined ATACH president Michael Bronstein and Gary Kaminsky of Acreage Holdings in their meeting with the White House’s Office of Management and Budget in August.

For more information, visit the ATACH website.

Webinar with NBA Hall of Famer Dominique Wilkins: Professional Sports & CBD: The Journey Ahead

Duane Morris, MGO and ELLO Capital will be hosting the webinar, “Professional Sports & CBD: The Journey Ahead,” on Tuesday, September 15, 2020, from 2:00 p.m to 3:00 p.m. Eastern.

REGISTER

About the Program

As awareness of the health benefits of CBD grows, professional athletes are voicing their support for the supplement as a safe substitute to help reduce inflammation and manage pain—and many are even investing in CBD or launching their own brands. Despite the World Anti-Doping Agency (WADA) removing CBD from their list of prohibited substances in 2018, many professional sports leagues continue to ban CBD, resulting in market and regulatory complexity for the sports world. This panel discussion will explore the legality of CBD use for professional athletes and provide an overview of the consumer and investor markets for CBD in the sports nutrition and recovery industries. The presentation will be followed by a lively discussion around the role of CBD in professional sports with NBA Hall of Famer Dominique Wilkins, who currently serves as vice president of basketball and special advisor to the CEO of the Atlanta Hawks.

Moderator

Presenters

  • Hershel Gerson, CEO and Managing Director, ELLO Capital
  • Seth A. Goldberg, Partner and Team Lead, Duane Morris Cannabis Industry Group
  • Chris Howard, Vice President, General Counsel & Chief Compliance Officer, E-Alternative Solutions
  • Dominique Wilkins, Nine-Time NBA All-Star; NBA Hall of Fame Inductee; and Vice President of Basketball and Special Advisor to the CEO, Atlanta Hawks

About the Duane Morris Cannabis Industry Group

Duane Morris attorneys in offices throughout the U.S. and internationally have extensive experience with the wide array of issues attendant to legal cannabis business activities, including licensing for cultivation, processing and dispensing; litigation; banking and finance; raising and deploying capital; mergers and acquisitions; protecting intellectual property; real estate development; public company representation and SEC filings; land use and zoning; healthcare and research; taxation; and cross-border transactions. In addition to advising participants in the medical and adult-use cannabis and hemp/CBD industries, as the industry has grown, Duane Morris attorneys experienced in cannabis-related issues frequently advise clients in other sectors whose businesses intersect with the expanding regulated cannabis sector.

About the MGO | ELLO Cannabis Practice

The MGO | ELLO cannabis practice provides a collaborative professional services offering that delivers world-class financial, tax and advisory services focused on empowering cannabis and hemp industry operators and investors to achieve their business goals. Its subsidiary ELLO Capital, a boutique investment bank, provides M&A, capital raising and strategic advisory services to companies and investors in cannabis, hemp and impacted industries. Together the cannabis platform delivers a suite of proven solutions to help operators, regulators and institutional investors navigate these complex industries.

New FDA Draft Guidance on Cannabis-Related Clinical Research Omits Discussion of Nondrug CBD Products

On July 21, 2020, the U.S. Food & Drug Administration (FDA) issued draft guidance outlining the agency’s current thinking on the development of drugs containing cannabis or cannabis-derived compounds. The new guidance is disappointing to many in the cannabis industry because it does not provide insight into the FDA’s views on the marketing of nondrug, hemp-derived CBD products.

To read the full text of this Duane Morris Alert, please visit the firm website.

Judicial Decisions Reflect Need for CBD Regulations and Legal Counsel

Consumer class actions regarding CBD marketing are on the rise. In recent months, a number of federal judges have placed lawsuits concerning the marketing of CBD-infused products on hold because the U.S. Food & Drug Administration—tasked with regulating those products under the 2018 Farm Bill—still has not issued regulations governing how they can be marketed. This further complicates the already confusing federal-state regulatory structure concerning the treatment of CBD products.

To read the full text of this Duane Morris Alert, please visit the firm website.

A Cannabidiol Catalyst? Recent Events Increase Pressure on FDA to Regulate CBD

By Justin M.L. Stern and Frederick R. Ball

For consumers, the widespread availability of products containing cannabidiol (CBD) is old news. But for those in the cannabis industry—and in particular, those monitoring applicable regulatory developments—the state of CBD remains largely in flux and continues to be marred by uncertainty.

Under the 2018 Farm Bill, the U.S. Food and Drug Administration (FDA) retained its regulatory authority over products derived from hemp, including CBD incorporated into products it traditionally regulates, such as food, dietary supplements, and cosmetics. Unfortunately for the industry, FDA has yet to propose or issue formal regulations concerning the manufacture, distribution, or sale of such products. At the same time, FDA has issued numerous warning letters to producers and retailers incorporating CBD into products operating in the complex gray area between state and federal law. Nevertheless, recent events occurring across all three federal branches of government may reflect an impetus for change in FDA’s approach to CBD products.

To read the full article, please visit the FDLI website.

Patented (and Unapproved) Therapeutic Uses for CBD

In this second article of his Cannabis Patent Review series, Duane Morris partner Vince Capuano reports on recently granted U.S. patents in various areas of cannabis technology.

He writes:

There are plenty of reports and testimonials on the medical benefits of cannabis. Time, and better data, will determine whether these benefits are realized, and whether some are overblown, and the U.S. FDA will decide when the therapeutic uses of cannabinoids are safe and effective, and approvable for human use in the U.S. The FDA has approved CBD (cannabidiol), the principal non-psychoactive constituent in cannabis, for the treatment of certain types of seizures. The approval of Epidiolex (NDA Approval Holder: GW Research Ltd.) brings the therapeutic use of CBD as an active drug substance within the jurisdiction of the FDA. Thus, because CBD is the active drug substance in an FDA-approved pharmaceutical (Epidiolex), the FDA is currently considering regulations for the testing and approval for all drug products containing CBD.

Read Mr. Capuano’s full analysis on this topic.

Read Part 1 in the series.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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