The U.S. Drug Enforcement Administration is proposing changes to federal drug-control laws that could effectively ban nearly all delta-8 THC products currently on the market and significantly upend the country’s $5 billion CBD industry, according to a presentation at a recent agency conference.
Products containing delta-8 THC and other cannabinoids derived from hemp, legalized nationwide under the 2018 Farm Bill, have proved enormously popular in states without regulated adult-use cannabis markets.
So, too, have products containing CBD, which can be converted into intoxicating delta-8 THC via a chemical process.
But delta-8 THC and other novel cannabinoids, many of which have unknown or poorly understood safety profiles, also have drawn increasing scrutiny from lawmakers and law enforcement.
To date, 14 states have banned delta-8 THC outright, though sales continue online and at smoke shops and other retailers.
Critics say the booming trade in hemp-derived cannabinoids was not what Congress intended when it legalized hemp – defined as cannabis plants with 0.3% THC by dry weight – and it takes advantage of a loophole that the DEA is proposing to close.
Scheduling D-8, restricting CBD
At a recent agency conference in Houston, Terrence Boos, chief of the DEA Diversion Control Division’s Drug & Chemical Evaluation Section, indicated that the DEA will propose a new limit of no more than 0.1% THC on a weight-to-weight ratio in hemp-derived products.
That recommendation, which the DEA said in its presentation came from the federal Department of Health and Human Services, is the same THC limit found in Epidiolex, the Food and Drug Administration-approved CBD pharmaceutical.
Boos’ presentation also indicates that federal drug laws would capture any cannabinoid “manufactured synthetically rather that [sic] produced by extraction from the plant.”
Since most delta-8 THC and other hemp-derived, intoxicating cannabinoids are produced via a chemical process from CBD source material – a “chemical synthesis,” Boos’ presentation notes – they would become controlled substances.
It’s still not clear what schedule of the Controlled Substances Act the DEA will propose for delta-8 and other synthetic cannabinoids.
Also unclear is how much appetite the DEA would have for enforcement.
If enforced, the DEA’s proposal would ban nearly every delta-8 THC product on the market, said Shane Pennington, an attorney with Vincente LLP, a cannabis-focused law firm.
It would also drastically transform the market for CBD products, he added.
Current federal law allows for hemp-derived products to contain 0.3% THC, three times the DEA’s proposed limit.
Delta-9 THC is a Schedule 1 controlled substance, but 22 states and the District of Columbia have legalized adult-use cannabis, and federal law enforcement has shown little interest in cracking down on what’s become a multibillion-dollar industry.
But even if the proposal is Schedule V, which is considered the most lax category, the impact on the existing regulated industry could be transformative.
“It’s really, really huge,” said Pennington, whose firm first brought attention to the DEA’s intentions.
“This would include possibly all of the delta-8 on the market,” Pennington said.
The DEA did not respond to requests for comment.
To date, federal agencies have proved mostly unwilling to tackle the new trade in hemp-derived cannabinoids including non-intoxicating CBD and intoxicating delta-8 THC, estimated to be a $5 billion market nationwide.
The federal Controlled Substances Act is silent on delta-8 THC, and federal law does not clearly define what qualifies as a synthetic cannabinoid.
In January, the FDA announced it would decline to regulate CBD, passing that responsibility onto Congress.
It’s possible that Congress could address intoxicating cannabinoids, which many states have moved to regulate or ban outright, when it revisits the Farm Bill.
That legislation is due to be renewed this year.
In the meantime, however, the DEA has declared that certain synthetically derived cannabinoids – including delta-8 and delta-9 THC ester – to be illegal, a revelation made in an email to attorney Rod Kight.
Kight told MJBizDaily on Thursday that he believes any attempt by the DEA to criminalize hemp-derived cannabinoids would be illegal.
“If the DEA attempts to schedule delta-8 THC and other THC isomers derived from hemp as ‘synthetic THC,’ then it will be blatantly violating the 2018 Farm Bill, which specifically includes ‘derivatives’ of hemp within the broad exemption included in the definition of ‘hemp,’” Kight wrote in an email. “A ‘derivative’ is, by definition, a synthesized compound.”
Also unclear is the DEA’s timeline.
The rulemaking process can take years and would be announced in the Federal Register.
Business owners and other stakeholders would have opportunity to participate during a comment period.
Chris Roberts can be reached at firstname.lastname@example.org.