The Drug Enforcement Administration (DEA) will soon be proposing new rules to clarify that synthetically manufactured cannabinoids like delta-8 THC are prohibited controlled substances.
At the agency’s 2023 Supply Chain Conference earlier this month, Terrance Boos, chief of DEA’s Drug and Chemical Evaluation Section, said that officials have received “multiple petitions” on the issue and are “in the process of modifying our [regulations]” on cannabis constituents based on recommendations from the U.S. Department of Health and Human Services (HHS).
One change, Boos said in the speech, which was first noted by the law firm Vicente LLP, would be to “decontrol CBD up to 0.1 percent THC on a weight-to-weight or weight-to-volume basis.”
Based on a slideshow presentation that accompanied the speech, it appears that he was referring to plans to deschedule synthetic CBD. Hemp-derived cannabidiol that’s naturally produced is no longer regulated by DEA as long as the preparations it is contained in have no more than 0.3 percent THC by dry weight.
Boos said that the intent of the forthcoming rulemaking will be to provide clarity and clear up confusion about the legal status of various cannabinoids since hemp and its derivatives were federally legalized under the 2018 Farm Bill.
Since then, the market for cannabis products, including edibles and tinctures, has rapidly expanded. And the emergence of intoxicating cannabinoids like delta-8 THC has prompted lawmakers in states across the country to enact a patchwork of regulations for the products.
Delta-8 THC does occur naturally in cannabis in trace amounts, and DEA has previously confirmed that those natural constituents are uncontrolled. But many products are being produced synthetically, through a chemical process that converts CBD into delta-8 THC.
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.
“That act of taking that substance in any synthetic step now brings it back under the CSA,” he said, adding that “a number of states have come up with [regulatory] responses. It’s somewhat of a patchwork right now.”
Marijuana Moment reached out to DEA for clarification, but a representative did not respond by the time of publication.
Earlier this year, DEA also clarified to an attorney that two cannabinoids that have emerged in state markets—delta-8 THC-O and delta-9 THC-O—do not meet the federal definition of legal hemp and are therefore considered illegal controlled substances.
The agency announced in 2020 that it had removed the prescription CBD medication Epidiolex from Schedule V of the CSA, fully descheduling the cannabis medication.
Shawn Hauser, a partner at Vicente LLP who co-chairs the firm’s Hemp and Cannabinoids Department, told Marijuana Moment on Tuesday that it’s important to keep in mind that DEA has so far only issued an interim final rule to codify regulatory changes in response to hemp legalization under the 2018 Farm Bill.
The point of addressing the cannabinoid issue at DEA’s supply chain conference is essentially part of the agency’s outreach for input as they prepare the final rule, she said.
“People really need to be paying attention,” Hauser said.
Not only is a final rule coming from DEA, but the market could also see significant changes under the next iteration of the farm bill later this year, as well as the ongoing broader review of marijuana scheduling that President Joe Biden directed last year.
“I think it’s important that companies look at this as a whole, because what we’re seeing in all these states is this debate as to where do these synthetics and intoxicating hemp products belong? What’s the best approach for public safety? What is their legality?” she said. “The states have had some legitimate level of confusion about the federal legality around some of these synthetically derived cannabinoids.”
Hauser attributes part of the confusion to the lack of regulatory guidance from the Food and Drug Administration (FDA), which has declined to enact rules allowing hemp-derived CBD products to be marketed as food and beverage items, or as dietary supplements. FDA says it needs congressional support to implement such regulations.
With respect to DEA’s future rulemaking on synthetic cannabinoids, it’s unclear what that might mean from an enforcement standpoint.
“I think it continues to be the case that enforcement resources are limited,” Hauser said. It seems likely that FDA will continue to enforce where there’s public safety issues and legality, like they did in the joint enforcement action in Minnesota.”
Meanwhile, HHS Secretary Xavier Becerra recently said his agency remains committed to “expeditiously” carrying out a scientific review of marijuana as part of Biden’s scheduling directive last year—but he’s making clear that the final decision is up to DEA.
U.S. Attorney General Merrick Garland said at a Senate hearing in March that DOJ is “still working on a marijuana policy” while awaiting the results of the scientific review from health agencies. (Full Story)