The Drug Enforcement Administration will be proposing new regulations soon to clarify that synthetically produced cannabinoids such as delta-8 THC is a controlled substance.
Terrance Boos of the DEA’s Drug and Chemical Evaluation Section said at the 2023 Supply Chain Conference held earlier this month that the agency has received “multiple requests” regarding the matter and is “in the process of modifying [regulations] on cannabis constituents based upon recommendations from the U.S. Department of Health and Human Services”.
Boos, in his speech (which was first noticed by law firm Vicente LLP), said that one change would be “to decontrol CBD up to 0.1 per cent THC based on weight to weight or weight to volume.”
According to a slide show that was shown to accompany the speech, he may have been referring to plans for de-scheduling synthetic CBD. Hemp-derived CBD that is naturally produced no longer has to be regulated by DEA, as long as it’s contained in products with no more than 0.3 per cent THC.
Via DEA
Boos stated that the upcoming rulemaking would be intended to clarify and remove confusion regarding the legal status of cannabinoids, since hemp and its derivatives have been federally legalized as part of the 2018 Farm Bill.
Since then, cannabis products have grown rapidly, including edibles, tinctures and other forms of cannabis. The emergence of intoxicating cannabis cannabinoids such as delta-8 THC has led lawmakers across the nation to adopt a patchwork regulation for these products.
Delta-8 THC is found in cannabis naturally, but in very small amounts. The DEA confirmed previously that these natural constituents were uncontrolled. Many products are produced synthetically through a chemical conversion of CBD into delta-8-THC.
Via DEA
That is not allowed, Boos said, emphasizing that “synthetic tetrahydrocannabinols were not exempted” from the Controlled Substances Act (CSA) even though hemp and its naturally produced derivatives were legalized.
He said that the act of taking this substance in any synthesized step brings it under the CSA. “A number of states” have responded with [regulatory] measures. It’s a bit of a patchwork at the moment.
Via DEA
Marijuana Moment contacted DEA to clarify the situation, but a representative had not responded by the publication date.
Earlier this summer, DEA clarified to a lawyer that two cannabinoids which have appeared on state markets –delta-8-THC-O and Delta-9-THC-O — do not meet federal definitions of legal hemp. They are therefore illegal controlled substances.
In 2020, the agency announced that the CBD prescription medication Epidiolex had been removed from Schedule V under the CSA. This de-scheduling of cannabis medicine was complete.
Shawn Hauser is a partner in Vicente LLP and co-chair of the firm’s Hemp and Cannabinoids Department. He told Marijuana Moment that the DEA had only released an interim final rule codifying regulatory changes as a response to hemp being legalized under the 2018 Farm Bill.
She said that the DEA supply chain conference was a way to solicit input from the public as it prepares the final rule.
Hauser stated that people need to pay attention.
The DEA will be releasing a final rule, but there could also be significant changes in the market with the next version of the Farm Bill later this year. Also, the President Joe Biden’s ongoing review of marijuana scheduling, which he directed last year, is still underway.
“It’s very important for companies to look at the whole picture, because we are seeing this debate in all of these states about where these synthetics and hemp-based intoxicants belong. What is the best way to ensure public safety? “What is their legality?” asked she. The states are confused about federal legality of some of these synthetically-derived cannabinoids.
Hauser explains that part of the confusion is due to the lack regulatory guidance provided by the Food and Drug Administration. The FDA has refused to adopt rules allowing hemp CBD products to be sold as food and beverages or as dietary supplement. FDA claims it requires congressional approval to implement these regulations.
It’s not clear what the future DEA rulemaking on synthetic cannabisoids will mean in terms of enforcement.
It seems likely that FDA will continue to enforce where there are public safety issues and legality, like they did in a href=”https://www.marijuanamoment.net/fda-looks-to-collect more cannabis data as it touts federal state partnership in enforcement action against delta-8-thc business/” rel=”noopener” target=”_blank”>the joint enforcement action in Minnesota/a>. The FDA is likely to continue enforcing where there are public safety and legality issues, as they did in in Minnesota.
HHS Secretary Xavier Becerra said recently that his agency is committed to “expeditiously”, carrying out a medical review on marijuana, as part of Biden’s scheduling directive from last year. But he made it clear that the DEA has final say.
At a Senate hearing held in March, U.S. attorney general Merrick Garland stated that the DOJ “is still working on a policy for marijuana” and is awaiting the findings of the scientific review by health agencies.
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