D9 is the New D8 or: How I Learned to Stop Worrying and Love Intoxicating Hemp
While storms of controversy rage about delta-8 THC (D8) and new hemp products with novel cannabinoids seem to appear every month, the oldest and most well-known cannabinoid is poised to take over the entire hemp industry. It is coming to a convenience store, CBD shop, wellness center, or drop-ship warehouse near you. I am talking about delta-9 THC (D9).
If 2021 was the year of D8, then 2022 will be remembered as the year D9 retook the cannabis market. This prediction is not about federal marijuana legalization or the enactment of more state marijuana medical and adult-use programs. Rather, I am referring to D9 in hemp, which is broadly lawful under federal law and legal to some degree under the laws of all 50 states. Congress and the Biden Administration are content to allow marijuana reform to crawl along at a glacial pace. State regulators are busy playing “whack a mole” in their attempts to deal with D8, THCO, HHC, and other intoxicating products marketed as hemp. Meanwhile, mainstream cannabis reform is arriving through the back door in the guise of hemp. Intoxicating hemp products with THC concentrations that do not exceed the legal limit of 0.3% on a dry weight basis with 10 milligrams (mg) or more of D9 per serving are already available to Americans throughout the US. This trend will expand in 2022.
In this article I argue that products containing hemp extract with D9 concentrations sufficient to cause intoxication that do not exceed the legal limit of 0.3% on a dry weight basis are not controlled substances under the federal Controlled Substances Act (CSA). I also address the legal issues these products face under the Food Drug & Cosmetic Act (FDCA) as regulated by the Food and Drug Administration (FDA) and conclude that they are either expressly lawful, or at least no more “unlawful” than CBD products, provided they follow the appropriate FDAC and FDA rules pertaining to the product class that they occupy (i.e., food, dietary supplement, cosmetic, etc.) Finally, I argue that attempting to regulate hemp products based on intoxication is a Fool’s Errand and that the regulatory focus should instead be on product safety and limiting access by minors.
Part 1- The 2018 Farm Bill legalized THC in hemp
The 2018 Farm Bill broadly legalized cannabis for the first time in over 80 years. As set forth in the statute and discussed in a 2019 paper by the Congressional Research Center entitled, “2018 Farm Bill Primer: Hemp Cultivation and Processing”, Section 12619 of the 2018 Farm Bill amended the CSA (21 U.S.C. §802(16)) to exclude hemp and hemp-derived products from the statutory definition of marijuana. Additionally, section 10113 created a new Subtitle G under the Agricultural Marketing Act of 1946 (AMA) (7 U.S.C. §1621 et seq.) that expanded the statutory definition of hemp. The current legal definition of “hemp” is “the plant “Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” It is important to note that “hemp” is broadly construed to include not only the plant, but also its “derivatives, extracts, cannabinoids” etc., none of which are controlled substances. Finally, Section 12619(b) of the 2018 Farm Bill amended the CSA to exclude the THC in hemp from the definition of “tetrahydrocannabinols.” In other words, D9 in hemp is not a controlled substance.
None of this is controversial.
In fact, it has all been confirmed by the DEA, an agency that has been notoriously unfriendly to hemp. In a virtual town hall hosted by the Florida Department of Agriculture and Consumer Services in June 2021, DEA Chief of Intergovernmental Affair Sean Mitchell stated: “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 percent on a dry-weight basis.” Additionally, in a September 2021 letter to the Alabama Board of Pharmacy (ABOP) Terrence L. Boos, Ph.D., Chief of the DEA’s Drug and Chemical Evaluation Section of the Diversion Control Division, stated: “[C]annabinoids extracted from the cannabis plant that have a D9-THC concentration of not more than 0.3 percent on a dry weight basis meet the definition of “hemp” and thus are not controlled under the CSA….. only tetrahydrocannabinol in or derived from the cannabis plant—not synthetic tetrahydrocannabinol—is subject to being excluded from control as a “tetrahydrocannabinol in hemp.” Click here to read and watch more on these two DEA statements.
It is noteworthy that D9 does not implicate the issues of “synthetic THC” and the Analogue Act that are often raised when discussing the legal status of D8. For this reason, addressing the legal status of D9 hemp products is easier and more straightforward than with D8, though this may initially seem counterintuitive.
Part 2- Congressional intent is irrelevant as to intoxicating hemp products
With respect to intoxicating hemp products, some of my colleagues take the position that they violate the “spirit” of the law. Whatever the so-called “spirit” of a law may be, which is usually subject to interpretation, this much is clear – you will never win or lose a case based on the “spirit” of a law when it conflicts with what the law actually says, often referred to as the “letter of the law”. This is an old legal principle. It was confirmed almost a century ago in a Supreme Court case involving an alleged tax violation: “[I]f the [Government], seeking to recover the tax, cannot bring the subject within the letter of the law, the subject is free, however apparently within the spirit of the law the case might otherwise appear to be.” United States v. Merriam, 44 S. Ct. 69 (1923) Every competent lawyer is aware of this principle, so when you hear one arguing a position based on the “spirit” of a law you can be sure the lawyer is aware that his position is weak. There is a related principle called “legislative intent”, which refers to what the legislative body (in this case, Congress) intended the law at issue to accomplish and how it was to be applied in various circumstances. Unlike the “spirit” of a law, legislative intent is a real thing Courts take into consideration when it is legally appropriate to do so. When is it legally appropriate to inquire as to what Congress intended when it enacted a law? The answer is well settled- legislative intent is only relevant when a statute is ambiguous. To this point, the Supreme Court recently stated: “In the context of an unambiguous statutory text, whether a specific application was anticipated by Congress is irrelevant.” Bostock v. Clayton Cty., 140 S. Ct. 1731 (2020) As I discussed in Part 1, above, the 2018 Farm Bill is unambiguous with respect to the legal status of hemp and THC in hemp. For this reason, the question of whether Congress anticipated the fact that it was legalizing intoxicating hemp products when it removed hemp and THC in hemp from the CSA is irrelevant. In other words, legislative intent does not matter when it comes to hemp, even when one of the practical applications of legalizing hemp was to legalize intoxicating products made with hemp. This application is irrelevant when analyzing the 2018 Farm Bill and the changes it made to the CSA since the statutory definition of hemp is unambiguous.
Divining legislative intent is notoriously messy, even when it is relevant and appropriate to do so. Legislators vote for or against bills for any number of reasons and two members of Congress with opposing political views can, and often do, vote for a bill because they believe it accomplishes their respective purposes. Most people assume that Senator McConnell did not intend for hemp to be legalized so people could use it to get high. This is probably true. However, he is only one among many members of Congress. Who can say with any certainty that other members of Congress who are in favor of cannabis reform did not vote to legalize hemp primarily because it removed THC from the CSA for the first time in almost a century? To quote the Supreme Court again, “[I]t is no accident that the countertextual legislative intent judges perceive invariably accords with what judges think best. It seems to me, however, that this Court is no more capable of saying with certainty what is best in this area than it is of saying with certainty (apart from the text) what Congress intended.” Zuni Pub. Sch. Dist. No. 89 v. Dep’t of Educ., 550 U.S. 81 (2007)
The Court makes an important point that we can apply to hemp law, which is that we cannot say with any certainty what Congress intended when it removed hemp and THC in hemp from the CSA other than looking to the statute. Is it unreasonable to think some members of Congress voted in favor of the 2018 Farm Bill primarily because they were happy to see THC removed from the CSA, even if only in small concentrations, as a first step towards broad cannabis legalization? What I am saying is this: even if the statutory definition of hemp was ambiguous and Congressional intent was relevant to our inquiry, we should consider that some members of Congress may have viewed the 2018 Farm Bill as an opportunity to open the door to cannabis and THC legalization and all it implies, including the legalization of intoxicating products. If we were able to see inside the minds of all members of Congress, which includes many who are strongly in favor of cannabis reform, we may find that many of them voted for the 2018 Farm Bill with the specific intention to legalize cannabis and intoxicating products made from it. If this sounds preposterous, consider that no one can say otherwise with any certainty. Ultimately, it is important to keep in mind that this is all academic since any discussion of legislative intent with respect to hemp is both speculative and irrelevant since the hemp provisions of the 2018 Farm Bill are unambiguous.
Finally, I have read the argument that products containing D9 in concentrations not exceeding 0.3% and which produce intoxicating effects are not lawful because the 2018 Farm Bill definition of hemp was meant to apply to on-farm biomass, not finished products. This is just another version of the “legislative intent” argument and is wrong for the reasons stated above. The Farm Bill’s definition of hemp does not make any reference to “on-farm biomass”. It simply defines hemp and removes it and the THC in it from the CSA. Moreover, as I referenced above, both the Congressional Research Service and the DEA agree that the 2018 Farm Bill legalized hemp products, not just the plant. Additionally, if we take this argument at face value and assume that the definition of hemp only applies to on-farm biomass and not to finished products, then all full spectrum CBD products containing up to 0.3% THC currently on the market and which have been marketed for several years are illegal. This is clearly not the case. Not even DEA takes this position.
Part 3- The FDA is not likely to regulate intoxicating hemp products anytime soon
Hemp products that are intoxicating and which contain D9 in concentrations not exceeding 0.3% are not controlled substances under federal law. However, they may be illegal under the FDCA. The FDA has been notoriously negligent in failing to regulate hemp products. For better or worse, it is highly unlikely that the FDA will regulate or be an impediment to the marketing of intoxicating hemp products. That being said, it is important to understand the FDA’s position on adding THC to food. The FDA states the following in an FAQ about THC:
- Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added? No. Under section 301(ll) of the FD&C Act [21 U.S.C. § 331(ll)], it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public… FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added.
The FDA has held this position for several years but has never enforced it, which is one of the reasons the CBD industry has flourished. Additionally, this position only applies to foods to which THC “has been added”. What about full spectrum hemp products containing THC along with other naturally occurring hemp compounds? Many of my colleagues and I contend that marketing them is not a prohibited act. I testified about this issue in 2019 at the only hearing the FDA has ever held on cannabis compounds. In my testimony, partially reproduced below, I discussed two “paths” forward with respect to CBD and food products. For our purposes in this article, the first “path” is applicable to THC and I have replaced “CBD” with “THC” because they are interchangeable in this context:
Section 301(ll) of the FDCA prohibits a drug from being added to food only if the substance:
- is intended to diagnose, cure, mitigate, treat, or prevent disease through its use in the food, as shown objectively by marketing and labeling representations; and
- is the exact same moiety as the active ingredient in an approved drug and is added to the food in the same dosage range as authorized by the new drug approval.
Hemp extract as a food is an exception to section 301(ll) notwithstanding that it contains THC. This is because THC is a naturally occurring constituent inherent in hemp, which has been marketed and used at least since the Civil War. The prohibition on marketing a drug in food applies only to a substance that is added to food and does not apply to a substance that is in food, even where the substance is identical to an approved drug. Additionally, hemp extract contains dozens of compounds and is not the same moiety as the FDA approved THC drugs.
In other words, hemp extract containing THC within the legal limit is not prohibited by the FDCA, despite that the FDA has approved THC drugs, because it is not the same moiety as those drugs and is a naturally occurring hemp constituent that has been marketed for over a century and has been safely consumed for millennia.
To summarize, it is possible that hemp products containing THC are illegal to market under the FDCA, though the better view is that they are not, at least when formulated using hemp extract. Regardless, it is notable that the FDA has not enforced its position with respect to CBD or full spectrum hemp products containing THC and appears unlikely to do so in the near term. Certainly, the FDA could change its enforcement priorities with respect to hemp products that cause intoxication, but it has not been moved to do so with respect to D8, which is not as well-studied as D9. Additionally, regulating hemp products based solely on intoxication is problematic for the reasons I discuss in Part 5, below.
Part 4- Dry weight matters
When discussing D9 hemp products with clients I always remind them to take their moisture content into consideration when calculating D9 concentrations. This is because the definition of hemp includes the term “dry weight”. Although common in the food industry, the concept of dry weight is mostly a mystery to laymen, including lawyers. This results in erroneous legal opinions. A colleague recently stated that intoxicating D9 hemp products are not lawful because the FDA has not come up with a way to account for the weight and moisture of other ingredients in finished products. Fortunately, this is not accurate. The FDA has, in fact, come up with a way to account for the weight and moisture of other ingredients in finished products.
For example, in July, 2020, the FDA released “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry”, in which it “recommends that sponsors, investigators, or applicants evaluating intermediates or finished products that contain cannabis or cannabis derived compounds base the calculation of delta-9 THC percentage on the composition of the formulation with the amount of water removed, including any water that may be contained in excipients.” Admittedly, this document is addressed to pharmaceutical companies and not manufacturers of food products containing hemp extracts since the FDA’s current position is that they cannot be added to food (see Part 3, above). However, the same principles apply.
Additionally, and perhaps more importantly, moisture content is routinely evaluated in manufacturing food products for texture, taste, and shelf life. For example, click here to read the Meter Group’s discussion of the moisture content of certain food products and its chart of the water weight of many popular candies. Among other things, you will learn that the water weight of an average circus peanut is 5%.
Circus peanuts may be fun to consider, but to bring things a little closer to what is happening in the hemp industry let us consider gummies. I know the moisture weight of a certain type of gummy is 12%. Converting that into milligrams relative to the total mg of the gummy gives us the following rough formula to produce 2018 Farm Bill compliant hemp gummies with 10mg of D9 each:
- 4000 mg- total gummy weight
- 12% moisture= 480mg of moisture/water weight which must be removed/accounted for
- 3520 mg of “dry weight” in the gummy after removing the moisture content
- 0.3% of 3520mg= hemp extract consisting of 10.56mg THC
Do not use this formula to produce hemp gummies! I am not a chemist, food product manufacturer, or mathematician. The above example is only provided for illustrative purposes, and I concede that my math may be wrong and/or that I may be leaving out other important considerations, including the moisture content of the hemp extract itself. My point is not to provide a precise formula for a 2018 Farm Bill compliant gummy, but to illustrate in general terms how an average gummy can be compliant with the 2018 Farm Bill while also containing 10mg of THC, which most people agree is sufficient to cause intoxication.
UPDATE: Shortly after publishing this article, my colleague Matt Zorn published an article on this topic in partial response to mine. You can read it by clicking here. In his article, Matt agrees with the premise of this article but disagrees with my “math” and contends that you cannot take a controlled substance, such as THC, mix and dilute it with a non-controlled substance and have a non-controlled substance. I agree. He employs the following example, which I have paraphrased for use in this article:
Consider a 5.5g gummy that has 3g of “Added Sugars,” such as cane sugar. That leaves, at most, 2.5g of cannabis derived material. Could this product contain “hemp”? Probably not. Because 15 mg out of 2.5g, even without dehydrating the gummy to account for dry weight, is .6%, more than twice the legal limit. Most likely, this is a Schedule I mixture.
To be clear, the final product, if diluted with non-hemp parts of the plant, would likely be a marihuana mixture as Matt describes above. However, if it diluted with hemp oil it is not. The primary point is that the fact that such a final product may be intoxicating is irrelevant to its legal status.
Failing to take dry weight into consideration could have drastic consequences. It could mean the difference between a lawful product and an unlawful one. Additionally, because different types of products contain different dry weights, some products may become more prevalent on the market than others and some may be impossible to make compliantly. For instance, is it possible to create a compliant and intoxicating hemp water product since you must account for dry weight?
Part 5- The 2018 Farm Bill does not prohibit intoxicating hemp products
Attempting to regulate hemp based on intoxication, rather than on the letter of the law, is a Fool’s Errand that will do damage to the entire hemp industry. Unfortunately, certain organizations are attempting to do this very thing and have been vocal in asserting that “hemp” means non-intoxicating cannabis. Aside from being flat wrong since the statute does not define hemp in terms of intoxication, this position raises significant and intractable issues.
First, what does it mean for a product to be “intoxicating” and why is intoxication per se bad? Sugar, caffeine, tobacco, kava kava, and kratom (not to mention beer and wine) are all legal products that produce intoxicating effects and are available for purchase in convenience stores. (By the way, if you do not believe that sugar is intoxicating then give a soda to a 10-year old and watch what happens. For a better and more wholesome experience, you can read this well-researched article in the Guardian, entitled “Is sugar the world’s most popular drug?”, which includes the finding that sugar induces “the same responses in the region of the brain known as the ‘reward centre’ as nicotine, cocaine, heroin and alcohol.”)
With all the unhealthy, addictive, and intoxicating compounds and products that are lawful, widely available, and easy to purchase throughout the US, why do some hemp organizations continue to stigmatize THC intoxication and promote taboos about it, particularly when federal law does not prohibit hemp products based on the fact that they cause intoxication?
Second, and viewing things from a less philosophical perspective, attempting to draw an artificial line in the sand to prohibit products that cause intoxication merely creates more problems. For instance, Oregon released proposed marijuana and hemp rules on November 11, 2021. Among other things, these rules attempt to control for intoxication by limiting the milligrams of THC in consumer hemp products. Of course, this does not prevent intoxication, as a person can simply consume more than the recommended serving size. More importantly, these types of regulations invariably prohibit clearly non-intoxicating full spectrum products that contain concentrations of D9 within the legal limit but in milligrams that exceed the amount allowed by the proposed regulations. Tweaking the allowed milligrams does not solve the problem. Increasing the allowable milligrams of D9 increases the likelihood that hemp products which produce intoxication will be lawful, while decreasing the allowable milligrams “captures” non-intoxicating hemp products. Finding the “sweet spot” that allows so-called “non-intoxicating” hemp products to be marketed while prohibiting intoxicating ones is unlikely since intoxication is dependent on several factors, including one’s metabolism, prior use and experience, expectations, and other factors.
Given that Congress broadly legalized hemp and hemp products without reference to intoxication, and so many other types of intoxicating products are lawful and widely available, attempting to prohibit hemp products that cause intoxication makes little sense. I should note that promoting regulations that route these hemp products into a state’s marijuana program, rather than prohibiting them outright, suffers from the same problems discussed above. In fact, this is the very scenario occurring in Oregon as I write this article. Additionally, routing intoxicating hemp products into state marijuana programs would immediately remove access to a vast number of hemp products for people who live in states where marijuana is not lawful. With respect to hemp industry participants, this strategy would also take from them important and profitable hemp products at a time when CBD sales are down and a vibrant hemp fiber industry remains an unrealized fantasy.
Intoxicating hemp products are here to stay. In fact, hemp has been the source of much of the recent research on novel cannabinoids, including intoxicating ones. Rather than regulating to prohibit intoxicating hemp products, the better strategy is to regulate them based on safety, consistency, and access by minors. Otherwise, two things will happen: first, hemp as we know it will mostly go away (see, e.g., the market for hemp fiber, which has never taken off), and second, unregulated and dangerous intoxicating products will be sold on the black market (see, e.g., recent deaths in Florida caused by synthetic street drugs).
To paraphrase one of my favorite films, the hemp industry and regulators should learn to stop worrying and love intoxicating hemp products, particularly since a majority of Americans already believe that cannabis and products containing it, including ones that cause intoxication, should be fully legalized. Hemp is opening the door to that reality, and we should embrace it.
December 16, 2021
Rod Kight is an international hemp lawyer. He represents businesses throughout the hemp industry. Additionally, Rod speaks at cannabis conferences, drafts and presents legislation to foreign governments, is regularly quoted on cannabis matters in the media, and is the editor of the Kight on Cannabis legal blog, which discusses legal issues affecting the cannabis industry. You can contact him by clicking here.