The term tetrahydrocannabinol (THC) is most often associated with the delta-9 THC cannabinoid, which is one of over 100 cannabinoids found in both high-THC marijuana and low-THC hemp. Delta-9 THC is also the cannabinoid most often responsible for getting cannabis users “high” and is the cannabinoid that has been explicitly prohibited by the federal Controlled Substances Act (CSA).
A new cannabinoid, delta-8 THC, however, is being produced from hemp-derived cannabidiol (CBD) and sold throughout the United States in various forms, everywhere from smoke shops to gas stations. Although it also produces psychoactive effects similar to delta-9 THC, delta-8 THC sales have not been restricted to regulated cannabis dispensaries because the compound falls within a legal gray area. The CSA prohibits the production and sale of marijuana (a term used to refer to strains of the cannabis plant containing more than .3% delta-9 THC), while the Agriculture Improvement Act of 2018 (2018 Farm Bill) legalized hemp and its derivatives (a term used to refer to strains of the plant containing less than .3% delta-9 THC). Producers of hemp-derived delta-8 THC products claim that their products are, therefore, legal under the 2018 Farm Bill.
Although delta-8 products contain less than .3% delta-9 THC, hemp and hemp-derivatives were legalized largely because they have little to no psychoactive effects. Because of delta-8’s psychoactive properties, federal agencies are now increasing scrutiny of delta-8, and some state legislatures are banning or restricting its use. Manufacturers, wholesalers, retailers, and consumers should be aware of the shifting legal landscape surrounding delta-8 THC before selling or using it.
The 2018 Farm Bill legalized industrial hemp production by removing hemp from the list of illegal controlled substances.
Last year, the US Drug Enforcement Agency, responsible for enforcing the Controlled Substances Act, issued a notice of interim final rule clarifying that all synthetically derived THC remains a controlled substance. While delta-8 is naturally occurring in hemp, it is present at very low levels. In order to produce the high-delta-8 substances on the market, it must be extracted using a chemical reaction process. Whether delta-8 is legal turns on the question of whether this process is the type of synthesis prohibited by the CSA. Industry groups such as the Hemp Industries Association (HIA) take the position that there is no generally accepted definition of “synthesis,” but even if delta-8 were synthesized, the scientific definition of “derivative” includes something that was synthesized from the original. Therefore, they maintain that delta-8 synthesized, or derived, from hemp was removed from the CSA entirely by the 2018 Farm Bill.
Those that would restrict the sale of delta-8 also point to the federal Analogue Act (21 USC § 813), which treats any substance “which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II” as a Schedule I substance. In response, the HIA claims that (1) based on principles of statutory interpretation, the amendments to the CSA which specifically remove “tetrahydrocannabinols in hemp” from the schedules of controlled substances trump the Analogue Act because they are newer and more specific than the Analogue Act, and (2) delta-8’s psychoactive effects are up to ten times less potent than those of delta-9, and are, therefore, not substantially similar to the effects of delta-8.
The above legal issues have not yet been resolved and businesses have seized on the ambiguity to produce and sell hemp-derived delta-8 THC products. Those wishing to expand or enter into this market, however, should be aware that it remains to be determined whether they are protected by the 2018 Farm Bill.
In addition, the US Food and Drug Administration (FDA) recently issued a consumer update providing information related to health risks associated with use of delta-8 tetrahydrocannabinol (THC). FDA’s consumer update provides “5 Things to Know about Delta-8” as described below.
- Delta-8 THC products have not been evaluated or approved by the FDA for safe use and may be marketed in ways that put the public health at risk.
- FDA has received adverse event reports involving delta-8 THC-containing products.
- Delta-8 THC has psychoactive and intoxicating effects.
- Delta-8 THC products often involve use of potentially harmful chemicals to create the concentrations of delta-8 THC claimed in the marketplace.
- Delta-8 THC products should be kept out of the reach of children and pets.
In addition to FDA’s consumer update, the US Centers for Disease Control and Prevention (CDC) recently issued an official CDC Health Advisory “to alert public health departments, healthcare professionals, first responders, poison control centers, laboratories, and the public to the increased availability of cannabis products containing delta-8 tetrahydrocannabinol (THC) and the potential for adverse events due to insufficient labeling of products containing THC and cannabidiol (CBD).” The CDC warns that “[v]ariations in product content, manufacturing practices, labeling, and potential misunderstanding of the psychoactive properties of delta-8 THC may lead to unexpected effects among consumers.” Like FDA’s consumer update, CDC notes a steady increase in the number of “adverse event reports” throughout the country resulting in user hospitalization or emergency department treatment. CDC also provides a number of recommendations for the public, consumers, public health departments, poison control centers, cannabis retailers, and health providers. Below we summarize some of the CDC’s key recommendations.
- Consumers should be aware of possible limitations in the labeling of products containing THC and CBD even from approved marijuana and hemp retailers. Products reporting only delta-9 THC concentration, but not total THC may underestimate the psychoactive potential for consumers.
- Consumers should be aware that products labeled as hemp or CBD may contain delta-8 THC, and that products containing delta-8 THC can result in psychoactive effects.
- Poison control centers have a new code available to identify delta-8 THC exposures.
- States, territories, and tribal nations that have passed laws allowing non-medical use of adult cannabis or that may allow such use in the future may consider requiring the reporting of total THC content, including ingredients like delta-8 THC and other compounds that may be synthetically produced, on product labeling.
- Retailers selling cannabis products should provide information, including total THC content on product labels, to consumers about the psychoactive qualities of delta-8 THC.
- There is no specific antidote for THC intoxication. Treatment is largely symptomatic and supportive care.
A number of states have recently taken action to ban or restrict delta-8 THC products. According to Greenway Magazine and CBD Oracle, 18 states have regulated, restricted, or banned delta-8 THC. Another four states (AL, IL, OK, and OR) are considering taking action. Thus, there are still 28 states, plus Washington, D.C. in which delta-8 THC products are legal under state law.
As federal agencies shift focus to delta-8 THC products, it is likely we see more states take action to regulate, restrict, and/or ban such products within their borders.