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In a much-anticipated move, sources recently reported that the Drug Enforcement Administration (“DEA”) will recommend rescheduling cannabis from a Schedule I substance to a Schedule III substance under the federal Controlled Substances Act.[1] This recommendation will likely be based on the Health and Human Services Report, which evaluated scientific evidence of cannabis use for medical purposes and determined that cannabis does have accepted medical value with a higher safety profile than Schedule II medications.[2] The DEA’s recommendation is also in line with President Biden’s directive for the Federal government to take steps to review how cannabis is presently scheduled under federal law.[3] In response to the DEA recommendation, the White House Office of Management and Budget will review the recommendation. If approved, there will be a public hearing allowing experts and the public to weigh in on rescheduling. Absent any major meritorious objections, cannabis will then be rescheduled from a Schedule I substance to a Schedule III substance.Continue Reading Bridging the Gap: Cannabis Rescheduling to Align Policy with Research

On May 4, 2022, the Food and Drug Administration (FDA) issued warning letters to five companies it asserts are illegally marketing products labeled as containing delta-8 tetrahydrocannabinol (Delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FDCA). Simultaneously, FDA issued a new consumer update “5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC.”  The consumer update and warning letters are a continuation and expansion of FDA’s efforts to warn the public about products that are not approved under the FDCA and to rein in the rapidly expanding market of products containing hemp-derived cannabinoids.  This set of warning letters marks the first time FDA has publicly taken enforcement action against products containing Delta-8 THC, and it will likely not be the last.
Continue Reading Warning! FDA Issues Warning Letters for Products Containing Delta-8 THC

*This article was originally posted in Law360 on June 4, 2019.

The much-anticipated public hearing last week at the U.S. Food and Drug Administration on cannabis and cannabis-derived compounds drew a wide audience of participants, with strong views on how the FDA should (or should not) regulate the controversial plant.
Continue Reading What We Learned From FDA’s Public Hearing On Cannabis*