Politics
DEA Defends Stance That Synthetic Cannabis Compound HHC Is Federally Banned In Response To Industry Lawsuits
The Drug Enforcement Administration (DEA) is resisting two hemp companies’ efforts to challenge its determination that a cannabinoid produced synthetically from components of the cannabis plant is federally illegal.
DEA issued a rule last month saying that while it had already considered hexahydrocannabinol (HHC) to be a Schedule I illegal substance under the federal Controlled Substances Act (CSA), the agency will now giving the compound its own unique drug code for classification.
That move is being contested in separate lawsuits from hemp businesses that say the agency’s decision is “unlawful.”
In addition to filing petitions for review, the companies are also asking federal courts to issue a stay blocking the agency’s action while the lawsuits proceed.
DEA, in briefs filed in the cases this week, argued that each petitioner “fails to meet any of the factors required to show that a stay pending review would be warranted.”
“The rule does not affect HHC’s previous status as a schedule I substance—all it does is separately list HHC and give it a separate drug code,” the agency’s briefs said.
“With or without the final rule, HHC is a schedule I controlled substance. Thus, even if this Court were to stay the final rule pending review, [the companies] would remain subject to the same preexisting legal and commercial risks for its actions related to HHC,” they say, “In contrast, a stay would undermine the government’s efforts to improve the regulation of HHC, including any approval process for applications to manufacture or procure HHC in limited quantities for permitted purposes. The public interest likewise disfavors a stay, which would create confusion about HHC’s status as a schedule I controlled substance.”
HHC can be found in trace amounts in cannabis plants but is also synthesized by hydrogenating cannabidiol (CBD). It’s sometimes sprayed on cannabis flowers that are low in delta-9 THC, the most well-known psychoactive component of marijuana, and its psychoactive effects are reportedly similar.
While the 2018 Farm Bill federally legalized hemp and its derivatives with less than .3 percent delta-9 THC on a dry-weight basis, DEA says that only applies to naturally occurring, and not synthetic, cannabinoids. As such, it is the agency’s position that HHC does not fall under the definition of legal hemp.
One of the ongoing cases, filed by Bluestar Operations, LLC before the U.S. Court of Appeals for the Fourth Circuit, cites a prior ruling in that jurisdiction that found the hemp-derived cannabinoid THC-O-acetate is federally legal despite DEA’s claim to the contrary.
“Congress intentionally employed expansive statutory language and did not prohibit cannabinoids subjected to ordinary extraction, refinement, conversion, hydrogenation, distillation, or similar manufacturing processes commonly utilized throughout the hemp industry,” the complaint says.
DEA’s move “conflicts with the plain text, structure, and purpose of the 2018 Farm Bill and unlawfully inserts limitations Congress neither intended, nor enacted,” it says. The agency’s action has “already caused immediate and concrete harm to the Petitioner, including substantial compliance costs, business uncertainty, reputational harm, disruption of commercial relationships, and interference with ongoing operations.”
“Congress, not executive agencies like the DEA, defines the scope of federal criminal liability. The DEA lacks authority to narrow Congress’s legalization of hemp cannabinoids through interpretive construction unsupported by statutory text.”
Bluestar said in a new response to DEA’s initial reply brief that the agency is “unable to defend the merits of treating hemp-derived HHC as a Schedule I controlled substance—a position contrary to binding Circuit precedent which this Court rejected” in the prior case on ThC-O-acetate.
“Respondents recast the challenged DEA rule as a weightless ‘technical amendment’ that injures no one and decides nothing,” it said. “They then flip the script by arguing that Bluestar lacks standing to challenge it. Respondents cannot have it both ways.”
The other new suit was brought by IHC Investments, Inc. in the U.S. Court of Appeals for the Ninth Circuit, which previously ruled that the federal legalization of hemp through the 2018 Farm Bill removed restrictions on a wide range of molecules produced by the cannabis plant—including the psychoactive cannabinoid delta-8 THC.
The petition says that “DEA effectively, and thus unlawfully, attempts to expand federal criminal liability through administrative interpretation, unsupported by the plain statutory text of the enabling legislation.”
“Congress did not prohibit converted cannabinoids, hydrogenated cannabinoids, or cannabinoids subjected to ordinary commercial processing techniques,” the complaint says. “Congress did not clearly authorize the DEA to criminalize broad categories of hemp-derived cannabinoids through administrative interpretation.”
Both petitions argue that DEA’s move last month violates the major questions doctrine, a precedent holding that if an agency seeks to decide an issue of major national significance, that action needs to be supported by clear congressional authorization.
The agency’s ban of HHC “carries enormous economic and political significance affecting a nationwide hemp industry involving billions of dollars in commerce,” the litigation brought by Bluestar says.
David Sergi, the attorney leading the new Ninth Circuit case for IHC Investments, said in a press release on Thursday that DEA’s action “directly conflicts” with the 2018 Farm Bill the federally legalized hemp and its derivatives.
“The DEA’s ruling has already caused immediate and concrete harm to hemp businesses nationwide,” he said. “That the reclassification has led to the immediate cancellation of contracts, loss of banking relationships, and the potential destruction of significant inventory.”
DEA, for its part, said in the rule it filed last month that “only tetrahydrocannabinols in or derived from the cannabis plant—not synthetic tetrahydrocannabinols—are excluded from control as ‘tetrahydrocannabinols in hemp.'”
“To clarify further, tetrahydrocannabinols produced through chemical conversion, even when hemp derived are considered synthetically produced for purposes of the CSA, do not qualify as ‘tetrahydrocannabinols in hemp’ under” the 2018 Farm Bill, the agency said.
The Federal Register notice wasn’t the first time that DEA addressed the legal status of HHC.
In a 2023 letter, Terrance Boos, chief of DEA’s Drug and Chemical Evaluation Section, wrote that HHC “does not occur naturally in the cannabis plant and can only be obtained synthetically, and therefore does not fall under the definition of hemp.”
The new filing signed by DEA Administrator Terrance Cole said that “this rule does not affect the continuing status of hexahydrocannabinol as a schedule I controlled substance in any way.”
“This action, as an administrative matter, establishes a separate, specific listing for hexahydrocannabinol in schedule I of the CSA and assigns a DEA drug code for this substance,” it said. “This action will allow DEA to establish an aggregate production quota and grant individual manufacturing and procurement quotas to DEA-registered manufacturers of hexahydrocannabinol, who had previously been granted individual quotas for such purposes under the drug code for tetrahydrocannabinols.”
The DEA notice cited a move last year by an international drug control body to add HHC to Schedule II of the United Nations Convention on Psychotropic Substances of 1971—but the document doesn’t note that when the Commission on Narcotic Drugs (CND) took the action, the U.S. was the only country to abstain from the vote.
DEA said that the U.S. Department of Health and Human Services (HHS) “concurs with the direct listing and drug code assignment of hexahydrocannabinol in the CSA.”
Meanwhile, under provisions of a large-scale spending bill signed by President Donald Trump late last year, the federal definition of legal hemp is set to change in November. Unless that language is altered or its effective date is delayed, as some lawmakers are pushing for, only hemp products with up to 0.4 milligrams of total THC per container will remain legal after November 12.
At the same time, however, the Trump administration is moving to more broadly reschedule marijuana under federal law, with a DEA hearing on the issue set to begin next week.
Read recent filings in the cases below:
Photo courtesy of Mike Latimer.
