May 25, 2023
A DEA proposal to regulate synthetic cannabinoids might affect the marketplace for CBD products, but experts are taking a wait-and-see approach.
The move was announced in a PowerPoint presentation at a recent supply chain conference hosted by DEA. The address was given by Terrance Boos, Section Chief, Drug and Chemical Evaluation Section.
Delta-8 THC presented as “designer drug”
Boos laid out plans to regulate delta-8 THC, classified in the presentation as a “designer drug,” under one of the schedules of controlled substances maintained by DEA, according to industry lawyers. In addition, Boos stated the agency is considering a limit of 0.1% THC on a weight-to-weight basis for CBD, based on a recommendation from the U.S. Department of Health and Human Services (HHS).
“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,” lawyers with Vicente LLP wrote in a May 11 post. “We do not think these regulations are imminent given that HHS seemingly just issued their recommendation.”
Most CBD products use industrial hemp raw material as a starting point. To qualify as hemp and not as marijuana, plants must have no more than 0.3% THC by dry weight. While that level has proven challenging to meet, the industry has come to terms with it. Even so, there are efforts afoot to increase the THC threshold to 1% by dry weight.
Proponents argue this is a more achievable goal from an agricultural perspective while at the same time yielding a raw material with little in the way of psychoactive potential.
THC levels in CBD products
However, finished CBD products made from hemp that matches the current definition have been yielding variable THC levels in the finished goods. This is especially true for products formulated with so-called “broad spectrum” extracts.
At least one company, Cornbread Hemp, has advocated for being transparent about THC levels and puts it on the label.
Boos mentioned in his talk that DEA is considering mandating that CBD products have no more than 0.1% THC content to be compliant, which is the same standard to which the Epidiolex CBD drug is manufactured.
While the 2018 Farm Bill removed hemp from the schedule one list of controlled substances, delta-9 THC, the principal psychoactive constituent found in marijuana, is still listed as a controlled substance.
Full rule language needed for full review
Jonathan Miller, general counsel to the U.S. Hemp Roundtable, said his organization is withholding full judgement until some proposed language for a rule is shared by DEA. He viewed Boos’ statements as more of a trial balloon.
However, he said his initial reaction is DEA’s proposal runs counter to language in the 2018 Farm Bill.
“If what is being suggested became a rule, it would be devastating to the industry,” Miller told Natural Products Insider. “I think it would also be illegal, but I wouldn’t be surprised if they did move forward. But I have cautioned people not to overreact until we see a final rule.”
Miller said he would not anticipate seeing any formal rule language until the fall of 2023 at the earliest.
Al-Mondhiry: High noon for delta-8 THC
Rend Al-Mondhiry, a partner in the law firm Amin Talati Wasserman, said the delta-8 THC issue has been festering since the molecule began to show up on the market in significant quantities several years ago.
Delta-8 THC can be found in the hemp plant, but only in very small amounts. The delta-8 THC in the marketplace is reportedly synthesized using CBD as a starting point. According to the American Chemical Society, the delta-8 THC phase began when companies holding large quantities of CBD that had suddenly dropped in price because of oversupply starting looking for a profitable way to use the material.
FDA considers delta-8 THC products intoxicating and posing serious health risks.
“It does look like DEA is going to address delta-8 THC issue, which is not a surprise,” Al-Mondhiry said. “It’s a substance that is not naturally occurring in meaningful amounts in the hemp plant, and there is some concern about the manufacturing process—though that is not necessarily in DEA’s purview.”
Need for continued engagement
Attorney Shawn Hauser, whose law firm, Vicente was among the first to bring Boos’ statements to widespread attention, said it’s critical for industry stakeholders to continue to engage with the regulatory process.
“We advise our clients to pay close attention and engage in federal and state cannabis reform, as there are many reforms at hand that will impact the legality of cannabis, and to focus on compliance with state laws that are becoming more and more complex as the industry continues to innovate,” she said.
DEA and HHS did not respond to requests for comment for this article.
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