DEA Proposes to Reschedule Hemp-Derived Cannabinoids
By Michelle Bodian, Shawn Hauser, Shane Pennington
May 11, 2023
At a U.S. Drug Enforcement Administration (DEA) supply chain conference last week, Terrance Boos, Section Chief, Drug and Chemical Evaluation Section, stated that the DEA will be releasing a rule to reschedule certain hemp-derived cannabinoids. While we don’t yet have a copy of the rule or information on the timing of issuance, the implications are significant and far-reaching.
It is important that businesses remain engaged with the current federal agency scheduling activity relating to marijuana and hemp that will impact the legality of cannabis products. The FDA and DEA are currently poised to make scheduling reforms for both marijuana and hemp, and key congressional legislation such as the 2023 Farm Bill may also change the legal classification of certain cannabis products.
Vicente LLP will provide updates as this story unfolds. In the meantime please reach out to Shawn Hauser or Michelle Bodian to discuss the implications for your business.
What We Know
DEA received recommendations and data from the United States Department of Health and Human Services (HHS) indicating up to 0.1% THC is safe. Based on that recommendation, DEA plans to modify regulations to “decontrol CBD up to 0.1% THC on a weight to weight (or weight to volume) basis.”
DEA intends to clarify via rulemaking, despite the 2018 Farm Bill, that any cannabinoid that is synthetic, contains a THC, or is produced through any kind of synthesis is a controlled substance under the controlled substance act.
What We Expect
We do not think these regulations are imminent given that HHS seemingly just issued their recommendation.
We expect DEA to review HHS’s recommendation, develop its own analysis, and eventually publish a proposed rule tracking FDA’s recommendation in the Federal Register. At that point, there will be a public comment period and an opportunity for interested parties to request on-the-record hearings. Our best guess is that the proposed rule will appear in the Federal Register this fall.
What We Don’t Know (But Are Trying to Find Out)
Given that we haven’t yet seen the regulations, we do not know the implications for states and interstate commerce. However, given the number of states that have passed legislation related to cannabinoids (novel, synthetic, or artificial), it is likely there will be a meaningful conflict between federal and state law. In addition, states may consider the DEA’s statements in shaping their state laws.
Vicente LLP will provide updates as this story unfolds. In the meantime please reach out to Shawn Hauser or Michelle Bodian to discuss the implications for your business.