Rod Kight / Philip Snow: Is the DEA About To Issue A Rule About Delta – 8 THC & Other Hemp Derivatives

Author Philip Snow

On May 4, 2023, during its annual Supply Chain Conference, the Drug Enforcement Administration (DEA) announced that it is “in the process of modifying [its regulations]” on cannabis constituents based on recommendations from the U.S. Department of Health and Human Services (HHS). The announcement came during a presentation on “Emerging Trends” by Terrance Boos, chief of the DEA’s Drug and Chemical Evaluation Section. In addition to a discussion of fentanyl and new synthetic opioids, Dr. Boos addressed “synthetic cannabinoids”, which according to Dr. Boos includes delta-8 tetrahydrocannabinol (THC) derived from CBD in addition to “Spice” and “Bath Salts”. Dr. Boos directly addressed delta-8 THC and devoted several slides of his presentation to it and “synthetic” cannabinoids in general:

If the product contains any quantity of synthetic tetrahydrocannabinol, it is controlled under schedule I of the CSA, unless it is specifically excepted or listed in another schedule.

As reported by Marijuana Moment, during his presentation Dr. Boos stated that converting cannabidiol (CBD) to delta-8 THC, “is not allowed” and that “synthetic tetrahydrocannabinols were not exempted” from the Controlled Substances Act (CSA) even though hemp and its naturally produced derivatives were legalized. “That act of taking that substance in any synthetic step now brings it back under the CSA.” Additionally, based on the slide show presentation, the DEA also intends to deschedule synthetic CBD.

This all raises several questions.

First, is synthetic CBD currently scheduled? No, “synthetic CBD” is not scheduled. It is not separately listed as a controlled substance on the May 2023 edition of the DEA’s list of controlled substances. Additionally, by definition “synthetic” CBD does not come from the marijuana plant. (“Marihuana” is controlled and it includes “all parts” of the plant.) Finally, CBD is not the same molecule as THC, which is a scheduled substance. So, we do not know why the DEA is discussing “descheduling” synthetic CBD when it is not scheduled to begin with.

Second, hasn’t the DEA already stated that delta-8 THC from hemp and, in fact, all cannabinoids from hemp, are not controlled provided their delta-9 THC concentrations do not exceed 0.3%? Yes, the DEA has stated on multiple occasions that delta-8 THC from hemp is not controlled. Notably, during a a video webinar called a “Town Hall with USDA and DEA” conducted by the Florida Department of Agriculture and Consumer Services on June 24, 2021, the DEA representative, Sean Mitchell, stated: “I also want to expand beyond delta-8. There’s delta-8, there’s delta-10, there’s all kind of different cannabinoids that are associated with cannabis sativa l that are kind of out there and making the rounds. So what I want to say, and I’ll be very, very deliberate and clear. At this time, I repeat again, at this time, per the Farm Bill, the only thing that is a controlled substance is delta-9 THC greater than 0.3% on a dry-weight basis.” The issue is not actually delta-8 THC, but rather delta-8 THC that is produced via a chemical conversion from CBD, ie, what is being called “synthetic” delta-8 THC. To this point, Dr. Boos’ slide presentation states the following:

Whether a cannabinoid product that has been synthetically produced from non-cannabis materials is controlled depends on whether that product contains ‘any quantity’ of a synthetically produced tetrahydrocannabinol. This includes cannabinoids products that are chemically identical to cannabinoids that naturally occur in the cannabis plant but that have been manufactured synthetically rather than by extraction from the plant.” (emphasis added)

Notably, the DEA does not offer any statutory support for this last sentence. It completely ignores the fact that the definition of “hemp” in the 2018 Farm Bill includes the term “derivatives” among the things that qualify as lawful “hemp”. As attorney Philip Snow and I discussed in detail in our June 11, 2021 legal opinion letter regarding delta-8 THC for the Hemp Industries Association (HIA), a “derivative” is, by definition, a synthetic compound. The Chemicool Dictionary defines a “derivative” as “a compound that can be imagined to arise or actually be synthesized from a parent compound by replacement of one atom with another atom or group of atoms.” In other words, delta-8 THC that is derived from hemp (ie, is “synthesized” from hemp) is exempt from control by the DEA. And, just to complete the circle, under the 2018 Farm Bill, CBD from hemp is itself “hemp”. This last point is a little counter-intuitive, but the statute is clear that “hemp” includes not only the plant itself but also its cannabinoids, isomers, extracts, derivatives, etc. In other words, CBD from hemp is lawful “hemp”, and a hemp derivative, such as delta-8 THC made from CBD, is also lawful “hemp”. The DEA cannot sidestep the broad exception that Congress carved out for hemp by simply ignoring one of the words in the definition.

Finally, the DEA’s statements about hemp-derived delta-8 THC also belie the first sentence in the statement above in the slide presentation and in other places, namely, that synthetic THC is the product of “non-cannabis materials”. CBD and other cannabinoids are cannabis materials. So, even by the DEA’s own definition of “synthetic THC”, namely THC derived from non-cannabis materials, delta-8 THC from CBD does not qualify since CBD is a “cannabis material”.

Third, is the DEA about to schedule delta-8 THC and, if so, what can the hemp industry expect? Based on Dr. Boos’ presentation, it does appear that the DEA is poised to propose a rule that places delta-8 THC and other forms of THC that are produced from CBD and other hemp cannabinoids (ie, hemp derivatives) into schedule I. However, as my friends at Vicente recently noted, the rule is not likely to be imminent. Additionally, in its article Vicente notes that “there will be a public comment period and an opportunity for interested parties to request on-the-record hearings.” I agree with this assessment. This means that the hemp industry, already battling efforts by prohibitionists and Big Marijuana to sharply restrict its activities in a state by state ground war, must also be prepared to respond in a strong and unified voice to any proposed rules by the DEA that overstep its legal authority by attempting to interfere with lawful hemp.

 

On May 4, 2023, during its annual Supply Chain Conference, the Drug Enforcement Administration (DEA) announced that it is “in the process of modifying [its regulations]” on cannabis constituents based on recommendations from the U.S. Department of Health and Human Services (HHS). The announcement came during a presentation on “Emerging Trends” by Terrance Boos, chief of the DEA’s Drug and Chemical Evaluation Section. In addition to a discussion of fentanyl and new synthetic opioids, Dr. Boos addressed “synthetic cannabinoids”, which according to Dr. Boos includes delta-8 tetrahydrocannabinol (THC) derived from CBD in addition to “Spice” and “Bath Salts”. Dr. Boos directly addressed delta-8 THC and devoted several slides of his presentation to it and “synthetic” cannabinoids in general:

If the product contains any quantity of synthetic tetrahydrocannabinol, it is controlled under schedule I of the CSA, unless it is specifically excepted or listed in another schedule.

As reported by Marijuana Moment, during his presentation Dr. Boos stated that converting cannabidiol (CBD) to delta-8 THC, “is not allowed” and that “synthetic tetrahydrocannabinols were not exempted” from the Controlled Substances Act (CSA) even though hemp and its naturally produced derivatives were legalized. “That act of taking that substance in any synthetic step now brings it back under the CSA.” Additionally, based on the slide show presentation, the DEA also intends to deschedule synthetic CBD.

This all raises several questions.

First, is synthetic CBD currently scheduled? No, “synthetic CBD” is not scheduled. It is not separately listed as a controlled substance on the May 2023 edition of the DEA’s list of controlled substances. Additionally, by definition “synthetic” CBD does not come from the marijuana plant. (“Marihuana” is controlled and it includes “all parts” of the plant.) Finally, CBD is not the same molecule as THC, which is a scheduled substance. So, we do not know why the DEA is discussing “descheduling” synthetic CBD when it is not scheduled to begin with.

Second, hasn’t the DEA already stated that delta-8 THC from hemp and, in fact, all cannabinoids from hemp, are not controlled provided their delta-9 THC concentrations do not exceed 0.3%? Yes, the DEA has stated on multiple occasions that delta-8 THC from hemp is not controlled. Notably, during a a video webinar called a “Town Hall with USDA and DEA” conducted by the Florida Department of Agriculture and Consumer Services on June 24, 2021, the DEA representative, Sean Mitchell, stated: “I also want to expand beyond delta-8. There’s delta-8, there’s delta-10, there’s all kind of different cannabinoids that are associated with cannabis sativa l that are kind of out there and making the rounds. So what I want to say, and I’ll be very, very deliberate and clear. At this time, I repeat again, at this time, per the Farm Bill, the only thing that is a controlled substance is delta-9 THC greater than 0.3% on a dry-weight basis.” The issue is not actually delta-8 THC, but rather delta-8 THC that is produced via a chemical conversion from CBD, ie, what is being called “synthetic” delta-8 THC. To this point, Dr. Boos’ slide presentation states the following:

Whether a cannabinoid product that has been synthetically produced from non-cannabis materials is controlled depends on whether that product contains ‘any quantity’ of a synthetically produced tetrahydrocannabinol. This includes cannabinoids products that are chemically identical to cannabinoids that naturally occur in the cannabis plant but that have been manufactured synthetically rather than by extraction from the plant.” (emphasis added)

Notably, the DEA does not offer any statutory support for this last sentence. It completely ignores the fact that the definition of “hemp” in the 2018 Farm Bill includes the term “derivatives” among the things that qualify as lawful “hemp”. As attorney Philip Snow and I discussed in detail in our June 11, 2021 legal opinion letter regarding delta-8 THC for the Hemp Industries Association (HIA), a “derivative” is, by definition, a synthetic compound. The Chemicool Dictionary defines a “derivative” as “a compound that can be imagined to arise or actually be synthesized from a parent compound by replacement of one atom with another atom or group of atoms.” In other words, delta-8 THC that is derived from hemp (ie, is “synthesized” from hemp) is exempt from control by the DEA. And, just to complete the circle, under the 2018 Farm Bill, CBD from hemp is itself “hemp”. This last point is a little counter-intuitive, but the statute is clear that “hemp” includes not only the plant itself but also its cannabinoids, isomers, extracts, derivatives, etc. In other words, CBD from hemp is lawful “hemp”, and a hemp derivative, such as delta-8 THC made from CBD, is also lawful “hemp”. The DEA cannot sidestep the broad exception that Congress carved out for hemp by simply ignoring one of the words in the definition.

Finally, the DEA’s statements about hemp-derived delta-8 THC also belie the first sentence in the statement above in the slide presentation and in other places, namely, that synthetic THC is the product of “non-cannabis materials”. CBD and other cannabinoids are cannabis materials. So, even by the DEA’s own definition of “synthetic THC”, namely THC derived from non-cannabis materials, delta-8 THC from CBD does not qualify since CBD is a “cannabis material”.

Third, is the DEA about to schedule delta-8 THC and, if so, what can the hemp industry expect? Based on Dr. Boos’ presentation, it does appear that the DEA is poised to propose a rule that places delta-8 THC and other forms of THC that are produced from CBD and other hemp cannabinoids (ie, hemp derivatives) into schedule I. However, as my friends at Vicente recently noted, the rule is not likely to be imminent. Additionally, in its article Vicente notes that “there will be a public comment period and an opportunity for interested parties to request on-the-record hearings.” I agree with this assessment. This means that the hemp industry, already battling efforts by prohibitionists and Big Marijuana to sharply restrict its activities in a state by state ground war, must also be prepared to respond in a strong and unified voice to any proposed rules by the DEA that overstep its legal authority by attempting to interfere with lawful hemp.

We will keep a close eye on this issue and intend to continue blogging and educating our clients about it as developments occur. If you have questions about how a DEA rule may impact your business, you can contact us to schedule a consultation.

May 18, 2023

Rod Kight, Cannabis industry attorney
ATTORNEY ROD KIGHT REPRESENTS CANNABIS BUSINESSES THROUGHOUT THE WORLD.

Rod Kight is an international cannabis lawyer. He represents businesses throughout the cannabis industry. Additionally, Rod speaks at cannabis conferences, drafts and presents legislation to foreign governments, is regularly quoted on hemp matters in the media, and is the editor of the Kight on Cannabis legal blog, which discusses legal issues affecting the hemp industry. You can contact him by clicking here

We will keep a close eye on this issue and intend to continue blogging and educating our clients about it as developments occur. If you have questions about how a DEA rule may impact your business, you can contact us to schedule a consultation.

 

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