Tennessee-based Gold Spectrum picked an inopportune day last month to debut an edibles line.
On Feb. 13, the hemp company – which has five retail locations in Tennessee and sells products in other states – announced the release of several flavored “Delta 8 + THC-O Cereal Bars.”
Popularized nationwide as a marijuana alternative since the passage of the 2018 Farm Bill, delta-8 THC can be found throughout states with no legal access, including Tennessee.
But THC-O, also known as THC acetate ester, is a relative newcomer, a “synthetic cannabinoid” created via chemical synthesis that delivers an intoxicating punch.
And, unlike “natural” hemp-derived cannabinoids, it is not protected by the Farm Bill.
Sales of THC-O products approached $200 million last year.
On the same day as Gold Spectrum’s announcement, North Carolina cannabis attorney Rod Kight received a letter from the U.S. Drug Enforcement Administration in response to a query he’d sent the previous summer.
According to the DEA, since THC-O “can only be obtained synthetically,” it falls outside the definition of hemp established in the 2018 Farm Bill.
The agency’s opinion became public thanks to Kight, but that hasn’t deterred Johnson City-based Gold Spectrum.
The company has no plans to remove its products with THC-O from store shelves or to change its manufacturing and distribution operations.
“I have assured our thousands of shop owners that everything is OK until a governing body makes an announcement,” Gold Spectrum founder and CEO Zach Green said.
“We should not change our entire business model based on what feels like an unofficial announcement.
“If federal or state governments publish information deeming THC-O harmful or illegal, we would of course shelve our products containing those substances pending further review.”
So far, the DEA has yet to take any enforcement action.
However, an increasing number of states have moved to ban hemp-derived intoxicating cannabinoids, including THC-O as well as other isomers of THC, including delta-6 and delta-10 THC.
The standoff underscores the proliferation of new cannabinoids entering the market and the difficulties of restricting access to them, despite concerns about their safety.
It also highlights the rift and growing tension between licensed cannabis businesses and the largely unregulated hemp sector, where companies are offering intoxicating products containing a growing array of synthetic, hemp-derived cannabinoids.
Both delta-8 and delta-9 – the latter is the “THC” people are most familiar with – exist naturally in the hemp plant.
By contrast, their chemically induced offshoots are manufactured via chemical conversions in a lab, typically through the extraction of delta-8 or conversion of CBD.
Both researchers and health officials say this chemical-conversion process can sometimes leave the end product with high levels of impurities as well as other novel compounds whose safety profiles are unknown.
Several nonpsychoactive cannabinoids common in the cannabis plant – including CBD, CBG, CBN and THCA – are sold in legal markets.
But the synthetic isomers of delta-9 are largely unregulated, though an increasing number of states have moved to ban hemp-derived intoxicating cannabinoids that have become the backbone of a multibillion-dollar market since the passage of the 2018 Farm Bill.
That legislation legalized hemp production nationwide, eventually unleashing an onslaught of products containing “intoxicating cannabinoids” derived from hemp.
However, the safety net offered by the Farm Bill hasn’t stopped states from banning hemp-derived cannabinoids.
State officials and others cite health concerns as well as some high-profile incidents such as the death of a Virginia toddler who ate his mother’s delta-8 THC gummies, according to prosecutors who are pressing murder charges.
Lawmakers in West Virginia are also proposing a ban.
At least 14 states have outlawed delta-8, according to Illinois-based O’Flaherty Law.
The federal government has largely avoided the matter.
In late January, the U.S. Food and Drug Administration declined to regulate products containing CBD, punting the job of drafting new rules to Congress, where cannabis reform has so far been unable to overcome mostly partisan deadlock.
Not the first
Gold Spectrum is one of many companies to experiment with THC-O.
It is one of several new cannabinoids emerging in vaporizer cartridges, edibles and other products.
Though a significant overlap exists among consumers of cannabis, CBD, hemp-derived delta-8 and other emerging cannabinoid products, states without legal adult-use marijuana sales have driven consumer adoption, according to industry experts.
Michael Brosgart, chief operating officer of Seattle-based Advanced Vapor Devices, said consumers in legal markets gravitate toward natural cannabinoids, but in markets without medicinal or recreational marijuana, “synthetics and other grey market products proliferate and appear as a viable option.”
That and more has helped fuel the growth of the cannabinoid market.
Chicago-based cannabis analytics firm Brightfield Group estimates sales of cannabinoid products in 2022 eclipsed $2.3 billion and could double to more than $4.7 billion by 2027.
However, the tail end of that forecast did not account for recent and ongoing state policy restrictions or the uncertainty of what might be included in the Farm Bill renewal.
Congress is due to renew the Farm Bill this session.
Some industry insiders and policy experts predict the wide-ranging legislation could be a vehicle for clearly defining novel cannabinoids, restrictions and concentration levels – although that is not a sure bet.
Regardless, “there’s a clear consumer market for psychoactive, hemp-derived cannabinoids,” said Madeline Scanlon, cannabis insights manager at Brightfield.
Interestingly, the percentage of consumers who purchased CBD products online the past few years has decreased significantly, while transactions at smoke and vape shops have gone up – perhaps a reverberation of the explosion of CBD stores in big cities, small towns and places in between.
Brightfield data shows 17.5% of consumers purchased CBD products online in the fourth quarter of 2022, down from 50.6% for the same period in 2020.
Meanwhile, 33.4% of consumers made transactions at vape and smoke shops in the fourth quarter, up from 19.1% two years earlier.
“Our most recent Q4 2022 consumer insights show 10% of Americans 21+ say they’ve purchased psychoactive, hemp-derived cannabinoids in the past 6 months,” Scanlon added via email.
“That’s more consumers than those that are purchasing oat milk (8%).”
Sounding the alarm
The rise of intoxicating, hemp-derived cannabinoids has widened a rift in the cannabis industry.
In one corner, manufacturers and retailers of hemp-derived cannabinoids argue their products are shielded by the Farm Bill and should be freely sold in states without laws prohibiting them.
In the other, regulated cannabis companies, consumer watchdogs and the science community are ringing the alarm over:
- The residual contaminants of solvents used in some cannabinoid extraction techniques.
- Their unknown, potentially dangerous, effects on users.
- The general confusion cannabinoids are causing in the marketplace.
California-based Jetty Extracts and Advanced Vapor Devices are among the cannabis companies calling for more oversight.
“Although the industry has come a long way from the Spice days of the past, many questions remain about the chemicals used in processing and whether residual toxins are carried into the extract,” said Nate Ferguson, chief product officer for Jetty, which doesn’t use synthetics.
A recent study from the Journal of Medical Toxicology linked smoking THC-O acetate with the potential to trigger the same lung complications that surfaced during the vape crisis of 2019 and early 2020.
During that outbreak, inhaled harmful additives found primarily in unlicensed marijuana vape products caused shortness of breath, fever and chills, coughing, vomiting, diarrhea, headaches, dizziness, rapid heart rate and chest pain. Dozens died.
The researchers, who analyzed a THC-O vape cartridge purchased online, contend that when THC-O acetate is heated, it can produce ketene, a toxicant linked to e-cigarette or vaping use-associated lung injury, or EVALI.
The lung illness has been cited in more than 2,800 hospitalizations and at least 68 deaths since 2019, according to the Centers for Disease Control and Prevention (CDC).
The study, published in December, came at the end of a banner year for THC-O products, which accounted for 8% of sales last year in the emerging cannabinoid market, or roughly $188 million, according to Brightfield data.
Dr. Neal Benowitz, a principal author of the report who also researched the EVALI outbreak, hopes to deter consumers from acetates altogether until more research is conducted.
“The purpose of this paper was really to warn people not to vape THC acetate,” said Benowitz, professor of medicine emeritus at the University of California, San Francisco.
“We’re not aware of any cases yet of lung injury, but we’re certainly concerned because of the strong biological possibility that this could be a problem.”
The report prompted California NORML to issue a consumer warning on Jan. 9 that THC-O acetate has not been tested for safety.
Dale Gieringer, director of California NORML, was particularly concerned the heating of THC-O acetate produced ketene similar to vitamin E acetate, the additive in vaping products “strongly linked to the EVALI outbreak,” according to the CDC.
“That really struck an alarm,” Geiringer told MJBizDaily.
“I had already been concerned by the proliferation of new synthetic cannabinoids that had begun to appear on the unregulated interstate CBD market.”
In its consumer alert, California NORML signaled out several other emerging psychoactive cannabinoids readily available in products that have not been tested for safe consumption, including THC-P, THCjd, THC-H, THC-B, HHC and delta-10.
Not worth the risks
Arizona-based The Flower Shop, a multistate, vertically integrated operator, has avoided using synthetic formulations to maintain brand identity as well as production and packaging protocols.
Company president Greta Brandt believes more cannabis operators will do the same without clarity and guidance from the federal government, and more state regulation.
“I really don’t think they’re going to touch the smaller cannabinoids,” she said.
“For a multistate operator, it’s just not worth it. If you’re going to make a change in one state, you’re going to roll that out across the U.S.” (Full Story)