The federal agency responsible for enforcing drug laws, the DEA, has stated that two types of cannabinoids that have recently appeared in state markets are not in compliance with the legal definition of hemp and are classified as controlled substances.
Last year, attorney Rod Kight sought clarification from the agency on the legal standing of delta-8 THC-O and delta-9 THC-O, and he followed up on this matter earlier this month.
The Drug Enforcement Administration issued a written response stating that the two cannabinoids in question “do not exist naturally in the cannabis plant, and can only be produced synthetically,” making them ineligible to be classified as hemp.
The letter, authored by Terrence L. Boos, the chief of the DEA’s Drug & Chemical Evaluation Section, explained the chemical makeup and medicinal effects of delta-9-THCO and delta-8-THCO are similar to those found in the cannabis plant.
In a blog post on Monday, Kight responded to the DEA’s letter, acknowledging that while he may not always see eye-to-eye with the agency on cannabis-related issues, he agreed with their stance on this matter and was not surprised by their findings.
Kight expressed concern over the increased availability of THC acetate ester (THCO), stating that he had long believed it to be a controlled substance under federal law. He explained that while THCO can be produced using cannabinoids from hemp, it is not a naturally-occurring compound in the hemp plant. Instead, it is a product of laboratory synthesis and, as such, should not be treated as a natural component of the plant.
Since the 2018 Farm Bill legalized hemp with a delta-9 THC content of 0.3% or less on a dry-weight basis, there has been significant uncertainty in the cannabis industry. As a result, the market for both natural and synthetic cannabinoids has expanded in states across the country.
Among the many new cannabinoids that have emerged, delta-8 THC has gained particular attention. While it can be produced synthetically from CBD, it also occurs in minuscule amounts naturally in the cannabis plant. Although it differs from CBD in that it does have intoxicating effects, some states have sought to regulate the product.
According to DEA officials, delta-8 THC products are not classified as controlled substances if derived from a natural plant rather than being synthetically created.
Meanwhile, a federal appeals court made a ruling last year indicating that delta-8 is not subject to control under the Controlled Substances Act (CSA). This was because the CSA only explicitly references natural delta-9 THC and because the federal statute defines hemp as “any part of” the cannabis plant, including “all extracts, derivatives, and cannabinoids” that contain less than 0.3% delta-9 THC by weight.
What about THC-O?
After analyzing the issue, the DEA determined that THC-O is not a naturally-occurring cannabinoid and is prohibited under federal law since it can only be produced synthetically.
In response to the DEA’s statement, Michelle Bodian, a partner at the Vicente Sederberg law firm, stated that the DEA’s report adds another layer of complexity to the already-complicated issue of determining the legality of hemp products. She noted that the agency’s position would require a detailed analysis of each cannabinoid.
According to Michelle Bodian, the latest DEA statement does not clarify the legal status of all novel hemp-derived cannabinoids. Still, it confirms that the agency considers Delta-9 THCO and Delta-8 THCO controlled substances. Bodian expressed hope that Congress will soon take action to address the legal status of all hemp-derived cannabinoids to prevent confusion and inconsistency in the industry.
Interest in THC-O has surged in the past year, with many consumers reporting that it is a highly potent cannabinoid. However, some studies have raised concerns about its safety, and advocacy groups like NORML have advised against using these unregulated, lesser-known cannabinoids.
Advocates argue that the current confusing regulatory landscape could be resolved if the federal prohibition on marijuana is lifted and people are allowed to use natural cannabis products, thus eliminating the demand for gray-area cannabinoids, particularly in states where marijuana remains illegal.
Aaron Smith, CEO of the National Cannabis Industry Association (NCIA), emphasized the need for responsible regulation of psychoactive cannabinoids, whether synthetic or naturally occurring, to ensure public health and safety. He called for an end to national prohibition and the implementation of sensible regulations at the federal level, allowing state cannabis laws to continue working effectively across the country.
The safety of cannabis-derived products has been a top concern for the Food and Drug Administration (FDA), prompting the agency to seek more data better to understand the risks and benefits of these products.
Despite ongoing calls from lawmakers, advocates, and stakeholders to establish regulatory guidelines for cannabidiol (CBD) as a dietary supplement or food item, the FDA recently announced that it would not create such rules. This has left the burgeoning CBD industry without clear regulations, raising concerns about the safety and quality of these products.
The FDA announced its plans to work with Congress to create legislative solutions to cannabis-derived products shortly after it issued guidance for the development of cannabis-based drugs. The guidance provided scientists with special considerations when working with hemp and marijuana. Meanwhile, Representative James Comer (R-KY), the newly appointed chair of the House Oversight and Accountability Committee, has pledged to address the FDA’s lack of regulations for CBD and other hemp-derived products.
Conclusion
The complex regulatory landscape surrounding hemp and cannabis-derived products continues to evolve as new cannabinoids emerge and gain popularity. While the recent DEA statement on THC-O has brought clarity to the status of some lesser-known cannabinoids, it has also highlighted the need for comprehensive federal regulations that can effectively address public health and safety concerns. As advocates and lawmakers continue to push for the lifting of federal marijuana prohibition and the establishment of sensible regulations, the industry and consumers alike will be looking to federal agencies like the FDA to provide clear guidance and oversight. With new leadership in Congress and growing public support for cannabis reform, there may be hope for a more coherent and consistent approach to regulating cannabis and hemp products in the years to come.