The Drug Enforcement Administration (DEA) recently announced at the 2023 Supply Chain Conference in Houston, Texas that it will soon unveil new rules regarding synthetic cannabinoids.
The DEA’s Section Chief of Drug and Chemical Evaluation Section, Terrance Boos, spoke on the topic of emerging trends at the conference on May 4. Boos confirmed that the DEA has received “multiple petitions” regarding synthetic cannabinoids, and that they’re currently reworking their rules to reflect recommendations from the U.S. Department of Health and Human Services (HHS).
Boos’s PowerPoint presentation covered a wide variety of topics, from modifications to drug scheduling, counterfeit pill operations, and internet drug trafficking. One section was dedicated to the “decade of responding to the harm,” which addressed the evolution of designer drugs such as spice/bath salts, synthetic opioids, designer Benzodiazepines, and synthetic cannabinoids “CBD to delta-8 THC.”
Boos noted that the “proposed rule treats synthetic CBD with <0.1% delta-9-THC same as AIA [agriculture improvement act] exempted material,” which could suggest plans to descheduling synthetic CBD.
The presentation also covered a brief history of delta-8 THC, including where it came from, how it’s made, states that have banned or regulated it, as well as data expressing the rise of the delta-8 products in 2021 and 2022. Boos explained that finding delta-8 THC only appears naturally in cannabis in very limited amounts, while most delta-8 THC products are made through a chemical process that coverts CBD into delta-8 THC. “That act of taking that substance in any synthetic step now brings it back under the [controlled substances act],” Boos said.
Boos confirmed that the new rules, which have not been publicly revealed, could change the classification of hemp-derived cannabinoids.
According to a brief analysis by Vicente LLP, the new rules could be on the way soon. “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,” Vicente LLP wrote on its website. “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.”
“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,” Vicente LLP wrote on its website. “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.”
In February, the DEA published a letter stating that delta-9-THCO and delta-8-THCO are not hemp, and instead are considered to be controlled substances. “Delta-9-THCO and delta-8-THCO do not occur naturally in the cannabis plant and can only be obtained synthetically, and therefore do not fall under the definition of hemp,” Boos wrote in the letter.
Last October, the Food and Drug Administration (FDA) held a webinar called “Understanding the FDA’s approach to cannabis science, policy, & regulation.” During the discussion, FDA principal deputy commissioner Janet Woodcock explained that the FDA manages “the scientific and medical assessment” for cannabis using information provided by the National Institute on Drug Abuse (NIDA). “We are working diligently on looking at the scheduling of marijuana under the Controlled Substance Act and what flexibilities we might have here,” said Woodcock. “That is a very high priority that the secretary of HHS is very interested in. We’re working closely with our partners at NIDA and also at the assistant secretary for [HHS].”
However, Woodcock confirmed that the DEA “has the final word” on decisions regarding scheduling substances. She added that this limitation makes it “very, very difficult” to study cannabis based on the currently existing protocols.