FDA and CDC Clear the Smoke on Delta-8-THC

Prohibition provides opportunities for not only black market but also unregulated market spaces. The DEA prohibits the possession, distribution, and use of delta-9-THC only, which has birthed a thriving cannabinoid market for delta-8-THC. Delta-8-THC can be found naturally in plants but to circumvent regulations on hemp, companies have turned to synthesizing delta-8-THC from CBD, which is allowed to be present in hemp plants, while THC in amounts greater than 0.3% is not. The product of this synthesis can now be given the label “hemp-derived” and be sold unregulated, but that loophole may not last long. 

The FDA and CDC released warnings in September 2021 that delta-8-THC use can lead to multiple unintended side-effects like “vomiting, hallucinations, trouble standing, and loss of consciousness.” Delta-8-THC’s non-regulated nature also raises concerns as to what exactly constitutes these formulations and in what amounts since there are no regulations as to what must be included in labeling. For now, the molecule remains in a grey area of regulation and can be capitalized on. 

Cannabinoid synthesis has seen rapid growth in the last few years with over 140 patent assets in total as of September 2021. Leading the space is Teewinot Life Sciences (TLS) which, through its subsidiary Full Spectrum Laboratories (FSL), owns one of only two patents directed towards synthesizing delta-8-THC from CBD. Arielium Health owns the second patent which uses acidicly enriched resin beads to synthesize THC from CBD rather than harsher chemicals like methylene chloride as used in the FSL patent, which according to OSHA is a potential occupational carcinogen. 

Founder of Arielium Health, Alex Nivorozhkin, Ph.D, mentions commercialization of the patented process through a personal device known as the CannaClick in the Spring 2020 Symposia Proceedings of the Cannabis Chemistry Subdivision. A CBD cartridge could be used with the device to create on-demand THC within 8 minutes. Truly, necessity is the mother of invention. A product like this could see some serious interest but could face difficulties reaching the market.

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