The United States Drug Enforcement Administration (DEA) is considering modifications to federal drug regulations that could potentially prohibit the majority of delta-8 THC products presently available and cause significant disruptions to the country's $5 billion CBD sector, as revealed in a recent agency conference.
Delta-8 THC and other cannabinoids derived from hemp, which were legalized across the nation under the 2018 Farm Bill, have seen considerable demand in states lacking regulated adult-use cannabis markets. Likewise, products containing CBD, which can be chemically transformed into intoxicating delta-8 THC, have enjoyed popularity. However, delta-8 THC and other emerging cannabinoids, often with uncertain or little understood safety profiles, have faced increasing scrutiny from lawmakers and law enforcement agencies.
Thus far, 14 states have completely banned delta-8 THC, but sales persist online and in smoke shops and other retail outlets. Critics argue that the thriving business in hemp-derived cannabinoids deviates from the intentions of Congress when it legalized hemp, characterized as cannabis plants with 0.3% THC by dry weight. This perceived loophole is what the DEA intends to close.
During a recent conference in Houston, Terrence Boos, the head of the DEA Diversion Control Division’s Drug & Chemical Evaluation Section, suggested that the DEA plans to implement a new threshold of no more than 0.1% THC in hemp-derived products. This proposal, which according to the DEA's presentation originates from the federal Department of Health and Human Services, matches the THC limit in Epidiolex, an FDA-approved CBD medication.
Boos' presentation also indicated that federal drug laws would encompass any cannabinoid "manufactured synthetically rather than produced by extraction from the plant." As most delta-8 THC and other hemp-derived intoxicating cannabinoids are created from CBD via a chemical process, they would be classified as controlled substances.
The future scheduling of delta-8 and other synthetic cannabinoids under the Controlled Substances Act is yet to be determined, as is the DEA's willingness to enforce these changes.
If these changes are implemented and enforced, the DEA's proposition would essentially outlaw all currently available delta-8 THC products, as stated by Shane Pennington, a lawyer at Vincente LLP, a cannabis-oriented law firm. He also suggested that it would radically reshape the CBD product market. Present federal law allows for hemp-derived products to contain 0.3% THC, three times the proposed limit by the DEA.
Although delta-9 THC is classified as a Schedule 1 controlled substance, it has been legalized in 22 states and the District of Columbia for adult use. Federal law enforcement has shown limited interest in intervening in this rapidly growing industry.
Regardless of whether the proposition falls under Schedule V, the most lenient category, it could still dramatically transform the existing regulated industry.
"This could include nearly all delta-8 on the market," said Pennington.
The DEA has not yet responded to requests for comments.
So far, federal agencies have primarily refrained from addressing the new hemp-derived cannabinoids trade, which includes non-intoxicating CBD and intoxicating delta-8 THC, and is estimated to be a $5 billion industry nationwide.
The federal Controlled Substances Act does not mention delta-8 THC, and federal law lacks a clear definition of what constitutes a synthetic cannabinoid. In January, the FDA declared it would not regulate CBD, handing the responsibility to Congress.
Congress may decide to address intoxicating cannabinoids, which have been regulated or banned outright by many states, during its review of the Farm Bill, due for renewal this year.
In the interim, the DEA has declared certain synthetically derived cannabinoids, including delta-8 and delta-9 THC ester, to be illegal, as revealed in an email to lawyer Rod Kight.
Sources:
United States. Drug Enforcement Administration. "Proposed Modifications to Drug Regulations." DEA Agency Conference, 2023.
"Agriculture Improvement Act of 2018." United States Congress, 2018, www.congress.gov.
Boos, Terrence. "DEA Regulations on Cannabinoids." DEA Diversion Control Division's Drug & Chemical Evaluation Section Conference, 2023.
Pennington, Shane. "Implications of DEA Regulation Changes." Vincente LLP, 2023.
United States. Drug Enforcement Administration. "Controlled Substances Act." www.dea.gov.
"FDA Regulation of CBD." U.S. Food and Drug Administration, 2023, www.fda.gov.
Kight, Rod. "Synthetically Derived Cannabinoids." Personal communication, 2023.
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