Ingestible products containing substances that are manufactured using naturally occurring hemp cannabinoids, such as CBD, and other chemicals to creating intoxicating hemp substances, such as Delta-8 THC, have become increasingly available throughout the U.S., being sold at gas stations, vape shops, and convenience stores. Such substances are often as or more intoxicating than marijuana, but by and large they have not been regulated with the same product safety requirements as marijuana that has been legalized in states for adult or medical use. The FDA views such intoxicating substances as prohibited in food and beverages, and while the FDA may take enforcement action, which it has done, it has not created a regulatory framework for the manufacture and ingestion of intoxicating hemp substances. Instead, it is waiting for Congress to clarify what some perceive to be a loophole in the 2018 Farm Bill that has allowed the proliferation of such substances, because of language legalizing hemp and its "derivatives."
Safety concerns have been raised about the intoxicating potency of these substances, as well as about the chemicals used to manufacture them, resulting in state regulations restricting or banning their use. Regardless of where you stand on whether the 2018 Farm Bill legalized intoxicating substances that can be manufactured using cannabinoids from legal hemp, in the absence of federal regulation, states have been banning or heavily restricting them in the name of public safety. While advocates of such substances decry those bans and limits, states who view them as a safety risk are taking action to protect their citizens.
In middle America, where cannabis legalization is spotty, foods and beverages containing intoxicating substances synthesized from hemp seem to have flourished, and those states have treated cannabis and intoxicating hemp substances differently. For example, in Minnesota, marijuana has been decriminalized for personal use, but has been legalized and regulated for medical use and can be sold in a handful of state-licensed dispensaries to medical marijuana card holders, whereas Delta-8 THC and Delta-9 THC artificially derived from hemp may be consumed in foods and beverages with certain serving size limitations that can be sold in stores that register with the state prior to sale.
In contrast, whereas Missouri has legalized and regulates the sale and use of marijuana for medical purposes, on August 1, Missouri Governor Michael Parson issued Executive Order 24-10, which bans "unregulated psychoactive cannabis products," including "delta-8 tetrahydrocannabinol (THC), delta-10 THC, hexahydrocannabinol (HHC), tetrahydrocannabinol (THC-O), tetrahydrocannabiphoral (THCP), tetrahydrocannabivarin (THCV), and other similar compounds." As the Executive Order states, "there are currently no safety standards, packaging requirements, or other regulations related to the safety of consuming unregulated psychoactive cannabis products in Missouri," and "actions must be taken to protect consumers, including children, from the sale of foods that include unregulated psychoactive cannabis products."
In Iowa, like Missouri, marijuana has been legalized for medical use, and the sale and consumption of marijuana is governed by Iowa's medical regulatory program, and, like Missouri, Iowa recently issued regulations, effective July 1, 2024, banning "synthetic consumable hemp products," including "Delta-8 THC, Delta-10 THC, Hexahydrocannabinol (HHC), Tetrahydrocannabiphorol (THC-P), and Tetrahydrocannabinol-O-acetate (THC-O)." Iowa's ban of synthetic consumable hemp products was challenged in Climbing Kites LLC, et al., v The State of Iowa, et al., et al., 4:24-cv-202 (SD IA), by a low-dose THC beverage manufacturer, along with other low dose-THC beverage manufacturers, but after the Court refused to enjoin the ban, the lawsuit was withdrawn.
As we have previously written, Wyoming, which has not legalized marijuana in any respect also bans substances that have been converted from naturally occurring hemp into a synthetic substance, such as Delta-8, and in South Dakota, where medical marijuana is legal, but recreational marijuana is not, a federal court recently upheld a ban, like Iowa's, on Delta-8 and other intoxicating substances converted from hemp. Hemp Quarters 605 LLC v. Governor Kristi Noem, et al., 3:24-CV-3016 (SD SD).
South Dakota HB-1125 went into effect on July 1, 2024, and provides that no person may "(1) chemically modify or convert industrial hemp as defined in § 38-35-1, or engage in any process that converts cannabidiol, into delta-8 tetrahydrocannabinol, delta9 tetrahydrocannabinol, delta-10 tetrahydrocannabinol, or any other tetrahydrocannabinol isomer, analog, or derivative; or (2) Sell or distribute industrial hemp or an industrial hemp product that contains chemically derived cannabinoids or cannabinoids created by chemically modifying or converting a hemp extract." HB 1125 includes the following definition for the term Chemically Derived Cannabinoid: "a chemical substance created by a chemical reaction that changes the molecular structure of any chemical substance derived from the cannabis plant. The term does not include: (a) Cannabinoids produced by decarboxylation from a naturally occurring cannabinoid acid without the use of a chemical catalyst; (b) Non-psychoactive cannabinoids; or (c) Cannabinoids in a topical cream product."
Clearly, the manufacture and sale of intoxicating substances using hemp cannabinoids, such as Delta-8, is being scrutinized. As such, manufacturers and sellers of such products need to be mindful of the regulatory landscape.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.