Politics
DEA Says Hemp Company Can’t Challenge Agency’s Stance That Synthetic Cannabis Compound HHC Is Federally Banned
The Drug Enforcement Administration (DEA) is defending its stance that a cannabinoid produced synthetically from components of the cannabis plant is federally illegal.
DEA issued a rule in May 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.
Two hemp companies filed separate lawsuits challenging the move, however, and on Tuesday DEA filed a brief in the U.S. Court of Appeals for the Fourth Circuit in response to one of them—arguing that the company, Bluestar Operations, LLC, does not have standing to bring the case and, even if it did, it would fail on the merits.
HHC, the agency said, “is a synthetic hallucinogenic drug that for decades has been included in schedule I under the Controlled Substances Act (CSA)” and has a similar chemical structure to THC, for which it has shared a DEA drug code until now.
Assigning the code does is “a technical change that has no substantive effect on HHC’s status as a schedule I substance,” DEA said.
“All the rule does is assign a tracking code to HHC to facilitate DEA’s administration of the CSA,” the brief said, adding that because the change “imposes no new obligations or liabilities,” Bluestar has not “identified any injury traceable to the rule that can be remedied in this proceeding.”
Beyond that, DEA said, “Bluestar does not even claim that the listing of HHC in schedule I is categorically unlawful.”
“Bluestar claims only that its specific products are hemp and therefore exempt from schedule I. But whether Bluestar’s HHC qualifies as a schedule I substance under the CSA or as hemp under the 2018 Farm Bill is a question of how those two statutory schemes interact and how Bluestar’s HHC is produced. Even under Bluestar’s view, there will still be HHC that does not meet the statutory definition of hemp; it is undisputed that at least some HHC products are properly included in schedule I, such as those with high concentrations of intoxicating substances. Nothing in the final rule conclusively adjudicates whether the HHC manufactured by Bluestar qualifies as hemp, nor does the rule impose independent obligations on Bluestar. Bluestar remains free to argue that its HHC qualifies as hemp in an appropriate case.”
“Even if this Court were to grant Bluestar’s requested remedy and vacate the final rule, HHC still would be a schedule I substance as a THC,” the DEA brief said. “Bluestar thus would continue to suffer the same alleged injuries, which all stem from HHC’s placement in schedule I.”
The drug agency also pointed to forthcoming planned changes in the legal status of hemp products.
Hemp derivatives with less than 0.3 percent delta-9 THC on a dry-weight basis were federally legalized under the 2018 Farm Bill that President Donald Trump signed during his first term in office. But late last year, the president signed new legislation containing provisions that will redefine hemp to make it so only products with 0.4 milligrams of total THC per container will remain legal after November 12.
As such, DEA said that the legal theory behind Bluestar’s case “will soon be overtaken by events.” The scheduled recriminalization of many hemp products “will defeat whatever remains of Bluestar’s claims,” it argued.
That said, Senate recently approved a funding bill that includes a provision to delay the effective date of the hemp product ban until December 11—a move that was supported by the White House. While that change has not yet been approved by the House of Representatives or enacted into law, industry supports believe it could give them more time to convince Congress to enact a regulatory structure for hemp products as an alternative to broad prohibition.
Meanwhile, the appeals court considering Bluestar’s challenge in June denied the company’s request for a stay on the drug code rule pending resolution of the litigation.
The U.S. Court of Appeals for the Ninth Circuit is considering a separate similar case brought by the hemp company IHC Investments, Inc.
Both suits say the agency’s decision is “unlawful.”
In earlier briefs filed in June, DEA has said that each petitioner “fails to meet any of the factors required to show that a stay pending review would be warranted.”
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.
The Bluestar case cited a prior ruling in the Fourth Circuit 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 said.
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 said. 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.”
The IHC Investments case cited a prior Ninth Circuit ruling 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 said 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 said. “Congress did not clearly authorize the DEA to criminalize broad categories of hemp-derived cannabinoids through administrative interpretation.”
Both petitions argued that DEA’s move 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 said.
DEA, for its part, said in the HHC rule it filed 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 recent 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.”
Read the DEA recent filing in the HHC lawsuit below:
