February 15, 2023
The Drug Enforcement Administration has concluded two synthetic cannabinoids, delta-9-THCO (delta-9-THC acetate ester) and delta-8-THCO, do not meet the definition of hemp and are controlled substances.
Some cannabis lawyers underscored the determination does not impact the legal status of delta-8 THC, which experts say can be found naturally in hemp in small quantities but often is manufactured from CBD through a process of synthesis.
In a Feb. 13 letter to attorney Rod Kight that he published, a DEA official found delta-8-THCO and delta-9-THCO do not meet the definition of hemp and are controlled substances because they fail to occur naturally in the hemp plant and can only be obtained synthetically.
Citing a research letter published in the Journal of Medical Toxicology, Kight said in his blog he has counseled his “friends not to consume THCO due to the potentially serious medical consequences of vaping it.”
He distinguished the synthetic cannabinoids above from those the cannabis plant naturally produces.
“I do not believe that the DEA’s letter to me regarding delta-8 THCO and delta-9 THCO impacts the legal status of cannabinoids that the hemp plant naturally produces, such as delta-8 THC and HHC, regardless of whether or not they are also produced synthetically,” Kight said in an email to Natural Products Insider. “In fact, the DEA has stated on numerous occasions that delta-8 THC from hemp is not controlled.”
Nonetheless, DEA’s recent determination “impacts the legal status of cannabinoids that can only be produced synthetically,” the cannabis lawyer added. “I think it is reasonable to say that those cannabinoids do not qualify as ‘hemp’ under the Farm Bill.”
DEA did not immediately respond to a request for comment for this article.
Michelle Bodian, a partner at the law firm Vicente Sederberg LLP, said she interprets some letters from DEA in recent years as meaning DEA is performing “a cannabinoid-by-cannabinoid analysis in order to determine whether the cannabinoid is not a controlled substance (occurs naturally in the cannabis plant) or is a controlled substance (it can only be obtained synthetically).”
In a follow-up email, she said DEA has recognized “a chemical difference” between delta-8-THCO and delta-8 THC.
DEA’s letter to Kight “concludes delta-8 THC-O is a controlled substance, but a September 2021 letter from DEA concludes delta-8 THC is not a controlled substance, because it is naturally occurring,” Bodian added.
In the September 2021 letter, DEA addressed the control status of delta-8 THC under the Controlled Substances Act (CSA), in response to a request from the Alabama Board of Pharmacy. DEA noted delta-8 THC can be found in the cannabis plant and be produced synthetically from non-cannabis material—with the latter being controlled under the CSA.
DEA noted hemp, as defined in the 2018 Farm Bill, is excluded from the definition of a controlled substance.
“Accordingly, cannabinoids extracted from the cannabis plant that have a [delta-9 THC] concentration of not more than 0.3 percent on a dry weight basis meet the definition of ‘hemp’ and thus are not controlled under the CSA,” the letter stated. “Conversely, naturally derived cannabinoids having a [delta-9 THC] concentration more than 0.3 percent on a dry weight basis are controlled in schedule I under the CSA as tetrahydrocannabinols.”
In May 2022, a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit held delta-8 THC fits within the definition of hemp under the Farm Bill.
But FDA, which declined to comment for this story, has concluded delta-8 THC poses “serious health risks.” For instance, the agency reported receiving 104 reports of adverse events in patients who consumed delta-8 THC products between Dec. 1, 2020, and Feb. 28, 2022. Among the adverse events reported: anxiety, confusion, dizziness, hallucinations, loss of consciousness, tremors and vomiting.
FDA also noted it has not approved or evaluated delta-8 THC products for safe use, the products have “intoxicating” and “psychoactive” effects, and they frequently involve the use of dangerous chemicals in the manufacturing process.
Jody McGinness is executive director of the Hemp Industries Association (HIA). He said his group favors regulation of hemp-derived cannabinoids, not prohibition of these substances.
“THCO, however, is an acetylated substance that cannot be found in the plant,” McGinness said in an email. “It feels surreal to even type this, but the HIA finds itself in agreement with the DEA on this one: THC-O isn’t hemp. Additionally, early research has shown that vaping THCO might pose significant health risks to consumers.”
He also distinguished natural products that can be synthesized, such as delta-8, from a growing category of substances that can only be chemically manufactured, such as THC-B, THC-JD, THC-H and PHC.
“None of those can ever be found in nature, meaning they aren’t hemp either,” McGinness concluded.
The 2018 Farm Bill clearly “protects hemp, extracts and cannabinoids. But that doesn’t mean it protects substances that might resemble hemp or cannabis but were made entirely in a lab,” U.S. Hemp Roundtable General Counsel Jonathan Miller said in an interview.
“The real problem is at the state level because states are convoluting these issues,” Miller shared.
For instance, he pointed to legislation in the Old Dominion. Two bills in Virginia, including HH 2294, which passed the state House, would limit hemp products to 2 mg (milligrams) of THC per package. Nolan Jackson, an attorney who works with Miller at the law firm Frost Brown Todd LLP, said similar bills are pending in the state of Washington that would restrict consumable hemp products to 1 mg of THC per unit and 3 mg per package.
The “vast majority” of full-spectrum hemp products and many broad-spectrum products would exceed the threshold under the legislation pending in Virginia, Miller said.
The proliferation of intoxicating products like delta-8 THC “really impaired our ability to fight for non-intoxicating hemp products at the local level and state level,” he added. “We would like to see these products strictly regulated and kept out of the hands of minors.”
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