Minor Cannabinoids: Exploring the Science, Legality, & Opportunities
The Responsible Corporate Officer Doctrine and the Food, Beverage and Agribusiness Industry — What You Need to Know
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
The executive order shifts policy on enforcement of criminal regulatory offenses, steering away from criminal enforcement of strict liability offenses in regulatory matters....more
On May 12, 2025, the Department of Justice (the “DOJ”) released its criminal—and, more specifically, white collar crime enforcement—initiatives under the current administration. This is typical each time new leadership...more
In past years we have discussed how opioid-related enforcement efforts have remained a top federal and state priority (here, here, and here). In 2024, opioid-related enforcement efforts continued across the entire opioid...more
DOJ Announces Agreement With Rite Aid to Settle Allegations of Violating the FCA and CSA in Relation to Opioid Dispensing - On July 10, the US Department of Justice (DOJ) announced that Rite Aid Corporation and 10 of its...more
Even with the expected rescheduling of cannabis from a Schedule I drug to a Schedule III drug, it will take more for it to be eligible for interstate commerce. Marijuana would remain subject to provisions of the Food,...more
On May 16, 2024, the U.S. Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) to reclassify marijuana from Schedule I to Schedule III under the federal Controlled Substances Act (“CSA”) and...more
On May 16th, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) to initiate the rescheduling of marijuana from a Schedule I to a Schedule III drug. The NPRM, which was published in...more
Moving marijuana under the Controlled Substances Act (“CSA”) from Schedule I to Schedule III will bring celebrated changes to the beleaguered state-sanctioned cannabis industries currently operating in 37 states, but will...more
The U.S. Drug Enforcement Administration (DEA) on May 16, 2024, issued a proposed rule to move marijuana from its current classification as a Schedule I drug to a Schedule III drug, thereby loosening federal DEA restrictions....more
On May 16, the Drug Enforcement Administration (“DEA“) published its 92-page notice of proposed rulemaking (“NPRM“) to move marijuana from schedule 1 on the Controlled Substances Act (“CSA”) to schedule 3 (ironically, the...more
Apologies for the cannabis puns in the title, but they are required by law. Okay, you are correct. That is not true. But it is true that trademark protection is important for individuals in the cannabis industry. Earlier this...more
On August 30, 2023, the federal government formally acknowledged the medical use and low potential of abuse for cannabis, with the US Department of Health and Human Services (HHS) recommending that cannabis be rescheduled to...more
FDA provides recommendations on sources of cannabis in clinical research, resources for information on quality, and control status considerations under the Controlled Substances Act. Key Points: ..The Food and Drug...more
The FDA’s recent decision not to regulate CBD like a food or dietary supplement leaves a multi-billion-dollar industry in a lurch. What’s next, and what should companies do now?...more
Congress recently introduced a bill that could expand access to therapeutic psychedelics that are designated as Breakthrough Therapies. These products are potentially useful in treating addiction, depression, post-traumatic...more
Over 50 years ago President Nixon declared a “War on Drugs,” leaving housewives over the country proclaiming marijuana to be the devil’s lettuce and urging sweet Billy to steer clear of the gateway drug...more
Most commentary I’ve seen on President Biden’s recently announced “three steps to end [the federal government’s] failed approach” to cannabis focuses primarily (often nearly entirely) on his decision to pardon all federal...more
On May 4, 2022, the U.S. Food and Drug Administration (FDA) for the first time issued warning letters related to products containing delta-8 tetrahydrocannabinol (delta-8 THC). FDA has previously sent warning letters to...more
With the list of states that have legalized adult-use cannabis continuing to grow, businesses are entering the industry at a rapid pace. However, one of the biggest questions facing these businesses is how to develop and...more
Aside from a small number of companies the FDA has permitted to pursue the development of psilocybin therapies (e.g., Compass), the majority of psychedelic mushroom sales in the U.S. currently violate both state and federal...more
On 15 November 2021, Representative Nancy Mace (R-SC) introduced a comprehensive cannabis reform bill: the “States Reform Act” (SRA). As discussed in further detail below, the SRA would deschedule cannabis from the Controlled...more
Hemp product producers and sellers must consider a large number of legal and regulatory compliance risks each day. Are their inputs and plant material coming from legally compliant sources? Are their products,...more
The September 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses a recent non-precedential Trademark Trial and Appeal Board decision regarding intent-to-use applications covering CBD products currently...more
The global cannabidiol (CBD) market size is expected to reach USD 13.4 billion by 2028. And yet a large part of that market—CBD-infused food, beverages, and dietary supplements—consists of unlawful sales. This article...more
The trend toward state-level legalization of cannabis has led to a surge in cannabis-derived products and a continually evolving market with many types of cannabis products for people as well as their pets. Analysts predict...more