Another cannabinoid has appeared: Delta-8 THC. Yes, THC. The cannabinoid, which occurs naturally in small amounts in hemp, can be synthesized from cannabidiol (CBD) or delta-9 THC, the main psychoactive constituent of cannabis. Unlike CBD, delta-8 THC Is produce psychoactive effects in users, although it is not of the same level of intoxication associated with delta-9 THC. Delta-8 THC can be found in several formats, including tinctures, functional drinks, vapes, and gummies.
There has been a spike in delta-8 THC products as an oversupply of hemp has driven down the prices of CBD and delta-8 THC synthesis has become a way for farmers and extractors to utilize this excess and to get their money back. As with CBD, manufacturers have been comfortable making and selling products with delta-8 THC due to the recent Farm Bill of 2018, says Felicia Leborgne Nowels, partner, government affairs and public policy at the firm of ‘Akerman lawyers.
The 2018 Farm Bill removed hemp from the Drug Enforcement Agency (DEA) jurisdiction as a controlled substance and gave the U.S. Department of Agriculture responsibility for growing and harvesting the plant. Specifically, the Farm Bill made a distinction between hemp and marijuana, defining hemp as a plant. Cannabis sativa L., or any part of the plant, including seeds, derivatives and extracts with levels of delta-9 tetrahydrocannabinol (THC) not exceeding 0.3% by dry weight. Of course, no threshold or restriction has been placed on delta-8 THC.
âThe problem we’re seeing now is that in the fall of 2020, the DEA issued an interim final rule. In this interim final rule, they included statements discussing THC of synthetic origin, and those would remain listed and a controlled substance, âNowels explains. âThe confusion is this: Delta-8 THC is derived from hemp, so it shouldn’t be programmed – it’s outside the DEA domain – but what’s the definition of ‘synthetic derivative’? “
More specifically, the provisional final rule states: âThe AIA [Agriculture Improvement Act of 2018] has no impact on the control status of synthetic tetrahydrocannabinols (for the controlled substance code number 7370) because the legal definition of “hemp” is limited to materials derived from the plant Cannabis sativa L. For tetrahydrocannabinols of synthetic origin, the concentration of Î9-THC is not a determining factor in determining whether the material is a controlled substance. All synthetic tetrahydrocannabinols remain Schedule I controlled substances.
Since the DEA does not provide an explicit definition for synthetic tetrahydrocannabinols, there is room for interpretation, and since hemp is no longer a controlled substance, supporters would argue that the hemp-derived delta-8 THC is no longer. not a controlled substance either. As of yet, the FDA has not taken any enforcement action against delta-8 THC products, but that doesn’t mean it won’t in the near future. Unlike CBD, delta-8 THC has not been studied as a new drug and therefore does not fall under the FDA’s drug exclusion rule. However, it has also not gone through a pre-market approval process, such as notification of new food ingredients.
“To know if the FDA will tackle delta-8 versus delta-9 [THC]; I think this will be taken into consideration as a whole. I don’t think the FDA will be looking at delta-8 alone in a vacuum, âNowels says.
States are taking matters into their own hands. Currently, 11 states ban Delta-8 THC entirely: Alaska, Arkansas, Arizona, Colorado, Delaware, Idaho, Iowa, Mississippi, Montana, Rhode Island, and Utah. Regulators in the states of Kentucky and Vermont have also clarified that their position on delta-8 THC is that it is a controlled substance. Illinois, North Dakota and Oregon are considering legislation banning the sale of delta-8 THC, and the Washington Liquor and Cannabis Board has temporarily banned synthetic hemp ingredients.
Given the lack of regulatory clarity, a patchwork of state regulations, and the fact that delta-8 THC products can be intoxicating, the American Herbal Products Association (AHPA; Silver Spring, MD) recently released a new policy. guidance discouraging âthe marketing of products for consumption by any meansâ that contain synthesized cannabinoids such as delta-8 THC or artificial cannabinoids. AHPA defines synthesized cannabinoids as âa cannabinoid synthesized in the laboratory or by industry using directed synthetic or biosynthetic chemistry rather than traditional food preparation techniques such as heating or extraction. They can be identical in nature or artificial since this definition refers only to the process of their creation.
AHPA’s definition of “artificial cannabinoids” is “any cannabimimetic compound which interacts with cannabinoid receptors but whose molecular structure is not found in nature”.
The hemp products industry is not slowing down. CBD and Delta-8 THC are just two of the many cannabinoids found in hemp, many of which are already making their way to the market, like CBG and CBC. As the FDA maintains its stance on CBD and investigates the market, the current market demands more substantial action to protect consumer safety. Legislation may be the solution, but the deadlock in Congress prevents the swift passage of laws. Meanwhile, demand is increasing, the industry is expanding, and regulators are sticking a few steps back.