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At the 2023 Supply Chain Conference held in Houston, Texas, a significant announcement echoed through the bustling halls.
Terrance Boos, the Drug Enforcement Administration's (DEA) Section Chief of Drug and Chemical Evaluation Section, confirmed that the DEA is readying new regulations on synthetic cannabinoids.
In recent years, synthetic cannabinoids have been at the heart of a contentious and rapidly evolving debate. They emerged as a new frontier in the discussion of controlled substances and the law, culminating in multiple petitions for their reconsideration. The DEA's anticipated modifications are in response to these calls for review and aim to reflect recommendations from the U.S. Department of Health and Human Services (HHS).
The presentation, a mixture of emerging trends, highlighted areas such as drug scheduling modifications, counterfeit pill operations, and internet drug trafficking. A distinct portion, dubbed as the "decade of responding to the harm", meticulously detailed the evolution of designer drugs - specifically focusing on synthetic cannabinoids, ranging from CBD to delta-8 THC.
Boos hinted at a potential seismic shift in the legal landscape surrounding synthetic cannabinoids. The new rule is proposed to treat synthetic CBD with less than 0.1% delta-9-THC as similar to the Agriculture Improvement Act (AIA) exempted material. This suggests a possible de-scheduling of synthetic CBD (H4-CBD), a move that could have monumental implications for the American industry.
Delta-8 THC was another key area of focus. Despite occurring naturally in cannabis in minimal amounts, most delta-8 THC products are made through a synthetic process converting CBD into delta-8 THC. Boos emphasized that any synthetic step brings the substance back under the Controlled Substances Act (CSA). These forthcoming rules might alter the classification of hemp-derived cannabinoids. According to Vicente LLP, a prominent law firm in the sector, businesses must keep abreast of the current federal agency scheduling activities related to marijuana and hemp.
Changes on the horizon, including new rules from the FDA and DEA, as well as potential modifications through the 2023 Farm Bill, could significantly impact the legal standing of cannabis products. The DEA is expected to carefully consider HHS's recommendations, develop its analysis, and subsequently publish a proposed rule aligning with the FDA's recommendations. The proposed rule will be published for public scrutiny in the Federal Register, opening a window for public comments and on-the-record hearing requests.
Earlier this year, the DEA established that delta-9-THCO and delta-8-THCO, which are synthetically derived, are not considered hemp but controlled substances. This firm stance on synthetic cannabinoids could potentially sway the development and implementation of new rules. The DEA's authority in scheduling substances was confirmed by the FDA during a webinar on their approach to cannabis science, policy, and regulation.
Janet Woodcock, FDA's principal deputy commissioner, acknowledged the agency's reliance on the National Institute on Drug Abuse (NIDA) for scientific and medical assessments of cannabis. Yet, she reiterated that the final decision on scheduling substances rests with the DEA.
The forthcoming rules have the potential to reshape the synthetic cannabinoid landscape, promising a turbulent but exciting time ahead. As the DEA navigates this intricate maze, the industry awaits with bated breath for the fall announcement in the Federal Register. The unveiling of these rules will undeniably mark a pivotal point in the narrative of synthetic cannabinoids in America.
