[co-author: Hanna Barker Mullin]

Cannabis: In Focus

• FDA and FTC Issue Cease and Desist Letters to Companies Selling Delta-8 Edibles
• FDA Releases Draft Guidance for Psychedelic Drug Research
• Federal Agencies Investigating Former Oregon Secretary of State’s Ties to Cannabis Company
• “Plain” Packaging Guidelines for Missouri Cannabis Products Go Into Effect July 30

FDA and FTC Issue Cease and Desist Letters to Companies Selling Delta-8 Edibles

On July 5, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) jointly sent cease and desist letters to six companies marketing edible products containing Delta-8 tetrahydrocannabinol (THC) in packaging similar to snacks and candy ordinarily eaten by children. The letters demand that the companies stop marketing edible Delta-8 THC products that imitate popular foods using packaging that is “likely to appeal to young children” and “make it easy for a young child to ingest in very high doses without realizing it.”

Delta-8 THC is one of many cannabinoids produced in the cannabis plant, and it can have psychoactive and intoxicating effects. Products containing Delta-8 are available in numerous forms, such as edibles, extracts, and tinctures. FDA has expressed serious concerns about products containing the hemp-derived cannabinoid Delta-8 THC. Specifically, the FDA issued a consumer update last year concluding that Delta-8 THC has “serious health risks.” This recent action builds upon FDA warning letters sent last year targeting CBD and Delta-8 THC products that make health claims or market to children.

Andrew Kline, senior counsel and cannabis industry group co-chair, recently spoke on this topic at a Washington Legal Foundation webinar, “Safeguarding Trademarks and Consumers from Rogue Edible-Cannabis Sellers.”

FDA Releases New Draft Guidance for Psychedelic Drug Research

In June 2023, FDA released a draft guidance for clinical investigations of psychedelic drugs. FDA noted that “the therapeutic potential of psychedelic drugs” has increased in recent years and noted that “designing clinical studies to evaluate the safety and effectiveness of these compounds presents a number of unique challenges.” Psychedelic substances, such as psilocybin, have shown promise for treating a range of addictions and mental health disorders, and their status under the Controlled Substances Act complicates research. The draft guidance will help researchers and drug developers navigate challenges specific to studying these types of substances. FDA noted that “the therapeutic potential of psychedelic drugs” has increased in recent years and noted that “designing clinical studies to evaluate the safety and effectiveness of these compounds presents a number of unique challenges.”

Federal Agencies Investigating Former Oregon Secretary of State’s Ties to Cannabis Company

Federal law enforcement agencies have convened a grand jury investigation into the relationship between former Oregon Secretary of State Shemia Fagan and the owners of La Mota, a cannabis company that Fagan worked for while serving in office. Fagan resigned in May this year after it was discovered that she had taken a consultant position with La Mota that would pay her $10,000 a month.

Oregon Governor Tina Kotek has also asked the Ethics Commission to investigate Fagan’s relationship with the business and its owners. The governor has also requested that the Oregon Department of Justice examine an audit that Fagan’s office conducted of the Oregon Liquor and Cannabis Commission, with which one of the company’s owners assisted.

At this point, federal prosecutors have sent subpoenas to five state departments requesting records.

“Plain” Packaging for Missouri Cannabis Products Goes Into Effect July 30

Missouri is set to become one of a small handful of states that require plain packaging in the adult-use cannabis market. Missouri state law includes a provision requiring that packaging for marijuana-related products include limited colors, a product name, required product labeling statements, a QR code, and text indicating the side effects and behavioral effects of usage. Earlier this month, Missouri state regulators released specific guidance to aid manufacturers, clarifying requirements for plain labeling of marijuana-related products. In addition to child-proof containers, packaging should have limited colors and limited graphics.

As we’ve written elsewhere, accidental pediatric cannabis overdoses are a rising concern.

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