No, Selling Delta 8 For Human Consumption is Not Legal Under Federal Law

A Discussion About the Federal Analogue Act

I remain deeply skeptical of and concerned about claims by the media, lawyers, and organizations that Delta 8 is “federally legal” for two reasons:  the Food, Drug, and Cosmetic Act (FDCA) and the Federal Analogue Act (Analogue Act). No Delta 8 product has been approved by the FDA, making many (maybe most) sales of Delta 8 products in interstate commerce unlawful; and if Delta 8 is a “controlled substance analog,” selling Delta 8 could subject a person to the same CSA penalties as if Delta 8 were controlled. This essay unpacks my skepticism.

The 2018 Farm Bill removed hemp, defined as cannabis and derivatives of cannabis with no more than 0.3 percent Delta 9 THC, from the definition of marijuana in the Controlled Substances Act (CSA). And it also removed “tetrahydrocannabinols in hemp” from the CSA schedules. These amendments indicate that Delta 8 sourced from cannabis having less than .3% delta 9 THC is not a controlled substances. And in informal guidance, DEA appears to support this view.

First, Sean Mitchell, Chief of Intergovernmental Affairs, was posed following question at a town hall: “Sean has received several questions saying that DEA is making, has said that Delta 8 is illegal. Would you take a quick second and talk about that?” Mitchell responds with the following:

Sure, and 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.

Next, in a letter to the Alabama Board of Pharmacy, DEA explained that “cannabinoids extracted from the cannabis plant that have a delta-9-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.”

But regardless of its status under the Controlled Substances Act post 2018 Farm Bill, the FDA can take enforcement actions against unapproved drugs introduced into interstate commerce under 21 U.S.C. § 331. No doubt FDA is aware of the growing Delta 8 market. The CDC recently released a health advisory in September 2021, stating:

• “Delta-8 THC products are increasingly appearing in both marijuana and hemp marketplaces, some of which operate legally under state, territorial, or tribal laws.”

• “Delta-8 THC is psychoactive and may have similar risks of impairment as delta-9 THC.”

• “Delta-8 THC intoxication can cause adverse effects similar to those observed during delta-9 THC intoxication.”

The FDA has published its own consumer update entitled “5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC” leaving no doubt as to its position:

The FDA warning explains:

• “The FDA is aware of the growing concerns surrounding delta-8 THC products currently being sold online and in stores.”

• “FDA is concerned by the proliferation of products that contain delta-8 THC and are marketed for therapeutic or medical uses, although they have not been approved by the FDA.”

• “Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of federal law, but also can put consumers at risk, as these products have not been proven to be safe or effective.”

• “Delta-8 THC has psychoactive and intoxicating effects, similar to delta-9 THC (i.e., the component responsible for the ‘high’ people may experience from using cannabis).”

• “The FDA is actively working with federal and state partners to further address the concerns related to these products and monitoring the market for product complaints, adverse events, and other emerging cannabis-derived products of potential concern.”

• “FDA will warn consumers about public health and safety issues and take action, when necessary, when FDA-regulated products violate the law.”

I could go on. Delta 8 is clearly on the federal government’s mind, and it isn’t just DEA. But the bigger debate has to do with where Delta 8 stands under CSA.

Brief History of the Federal Analogue Act

Enacted by Congress in 1986 to combat the “designer drug” problem, the Analogue Act is a catch-all statute that permits federal prosecutions of actions involving drugs that are substantially similar to drugs listed in the schedules of the CSA. Its purpose “is to prevent underground chemists from producing slightly modified drugs that are legal but have the same effects and dangers as scheduled controlled substances.” United States v. Hodge, 321 F.3d 429 (3d Cir. 2003).

As enacted in 1970, the Controlled Substances Act features a reticulated scheme of subjecting drugs or other substances to federal control. Under 21 U.S.C. 811(a), DEA can schedule drugs through administrative rulemakings after making the findings prescribed in 21 U.S.C. 812(b). Before initiating scheduling proceedings, however, DEA must gather data and request from the Secretary of HHS a scientific and medical evaluation and a recommendation as to whether a drug should be controlled. This process can take years. And if DEA concludes that a drug should be scheduled, any interested person can request a formal rulemaking proceeding under the APA, which is an administrative hearing allowing parties to take and submit evidence. This takes time too.

The proliferation of “designer drugs” in the 1980s exposed weaknesses in the scheme. The legislative history to the Analogue Act explains that Congress was concerned that underground chemists could easily and cheaply spawn offshoots of already controlled substances having slightly different chemical structures but similar effects, faster than DEA could execute rules. And these designer drugs could be spawned in numbers such that expeditiously scheduling each one according to these procedures would overwhelm DEA. In 1984, Congress enacted the Comprehensive Crime Control Act giving DEA, 21 U.S.C. § 811(h), a tool that gave it the ability to temporarily schedule uncontrolled substances on an emergency basis to avoid an “imminent hazard to the public safety.”

But even this emergency authority to bypass normal rulemaking requirements could leave the agency half a step behind, as it did with MDMA. (See United States v. Caudle, 828 F.2d 1111 (5th Cir. 1987)). To bring law enforcement in step and adapt the CSA to the needs of the times, the Analogue Act modified the CSA to automatically prohibit substances intended for human consumption that are substantially similar to an already-prohibited substance.

Under 21 U.S.C. § 813(a), “a controlled substance analogue shall, to the extent intended for human consumption, be treated, for the purposes of any Federal law as a controlled substance in schedule I.” The requirement that a controlled substance analogue must be “intended for human consumption” distinguishes activities involving controlled substance analogue versus controlled substances. In particular, the “intended for human consumption” limitation permits ongoing research involving analogues that might be more difficult if scheduled. And it is also why uncontrolled substances are frequently marketed or labeled as “bath salts” and not for human consumption. Whether a substance is “intended for human consumption” depends on several factors listed in 21 U.S.C. § 813(b), largely centered on how the controlled substance analog is marketed or labeled.

To be a “controlled substance analogue” a substance must be (1) substantially similar to the chemical structure of a controlled substance in schedule I or II and 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; or (2) with respect to a particular person, which such person represents or intends to have 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. 21 U.S.C. § 802(32)(A).

Delta 8 is a Controlled Substance Analogue

Applying these statutory definitions, Delta 8 is most likely a “controlled substance analogue.”

First, the chemical structure of Delta 8 is substantially similar to the chemical structure of Delta 9. Delta 8 is an isomer of Delta 9, a controlled substance in Schedule I. The difference between the two molecules is the location of a double bond between two carbons.

Although courts vary in interpreting what it means for a substance to have a “substantially similar” chemical structure to another substance, Delta 8 would qualify under any judicial interpretation. For example, United States v. Klecker, 348 F.3d 69 (4th Cir. 2003), the Fourth Circuit affirmed a finding that “Foxy” and DET had substantially similar chemical structures because they shared the same core arrangement of atoms of tryptamine. Delta 8 passes this test. Put simply, if Delta 8 does not have a chemical structure similar to Delta 9, then no two molecules could ever be substantially similar.

Second, Delta 8 could be shown to have similar effects on the central nervous system. Substantially similar pharmacological effect, like chemical structure, is a question of fact, that can be proven to a jury with science, anecdotal reports, affidavits, and expert testimony. With the body of information now available about Delta 8, proving it has a substantially similar pharmacological effect to Delta 9 should not be hard. For example, the FDA notice linked above says that “Delta-8 THC has psychoactive and intoxicating effects, similar to delta-9 THC,” and identifies evidence to support that conclusion. Delta 8 is often marketed as a legal high equivalent or similar to Delta 9.

The difference between Delta 8 and Delta 9 is not in effect but potency. Gram for gram, Delta 9 is stronger than Delta 8. But efficacy refers to the effect a drug has on a human being while potency refers to the dosage needed to achieve that effect. As the United States explained in briefs filed in United States v. Lei Zhang I pulled from Westlaw:

Defendant Snell also claims that Dr. Prioleau's testimony that 4-MMC and 4-MEC were less potent than methcathinone undercuts her opinion about the substantial similarity of the substances' pharmacological effects. This challenge fails for two reasons. As the prosecution and defense pharmacology expert witnesses testified, there is a difference between the “effect” or “efficacy” of a substance, which is the focus of the “pharmacological effect” prong of the definition of “controlled substance analogue,” and its potency, which is a measurement of the dosage needed to achieve a particular effect. Differences in potency do not undercut similarity of effect.

and

With the efficacy it means that you may have to take a different amount of the drug but you can reach the high -- you can reach a similar high. So, for example, you might have to take a lower dose of methamphetamine to get a -- to get the same stimulant effect that you would get with amphetamine. So they have the same efficacy or they're substantially similar. But for something like caffeine, which is also a stimulant, no matter how much caffeine you take, you will never get the same high that you will get when you take methamphetamine or amphetamine. So it will never reach that efficacy. So you will never have that substantially similar pharmacological effect. Now when we're talking potency, as I had mentioned, it depends on the dose you take. So *7 you take -- the dose to produce the effect will be different but, once again, with efficacy, you can still reach that same high. It all depends on the dose you take. But for something that don't [sic] have the same efficacy, you will never reach it. So the person who consumes caffeine and methamphetamine, no matter how much caffeine you take, you'll never have the same high that you get with methamphetamine.

Indeed, the sentencing guidelines appear to expressly contemplate this possibility: “Whether a lesser or greater quantity of the controlled substance not referenced in this guideline is needed to produce a substantially similar effect on the central nervous system as a controlled substance referenced in this guideline.” U.S.S.G. 2D1.1 (No. 6 -- Analogues and Controlled Substances Not Referenced in this Guideline).

The plain meaning of the statutory definition of “controlled substances analogue” also does not appear to require comparing an analogue to a controlled substance on a 1:1 or molecule-by-molecule basis. Certainly, the first part of the definition requires comparing molecular structures. But the second part of the definition simply requires comparing a “substance” to a controlled substance or drug in schedule I or II. Nothing in this requirement precludes having more of an analogue or less of a controlled drug or substance as the basis for the comparison. The “substance” on the analog side could consist of 100mg and the drug or substance on the controlled substance side could be 50mg.

Delta 8’s Status as a Controlled Substance Does Not Determine Analog Status

Nothing about DEA’s recent statements in informal guidance should persuade anyone that selling Delta 8 for human consumption under the CSA by way of the Analogue Act. Start with Mitchell’s “deliberate and clear” statement: “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.” That statement is correct. Naturally sourced Delta 8 is not a controlled substance, unless it has delta-9 THC greater than 0.3% on a dry-weight basis.

But in view of the Analogue Act, a “controlled substance analog” is not a “controlled substance.” Rather, the Analogue Act directs courts to treat certain substances not on the schedules as if they were. Just read the statute, 21 U.S.C. § 802(32)(C): “the term” controlled substance analog “does not include – (i) a controlled substance.” A analogue is, by definition, not a controlled substance. When Mitchell says that “the only thing that is a controlled substance is delta-9 THC greater than 0.3% on a dry-weight basis,” he offers no opinion on whether Delta 8 is an controlled substance analogue. Certainly, he doesn’t say that selling Delta 8 for human consumption is legal activity under the CSA.

Second, DEA’s statement in its letter to the Alabama Board of Pharmacy: “cannabinoids extracted from the cannabis plant that have a delta-9-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.” This statement is a little more difficult to unpack because 21 U.S.C. § 813(a) states that a controlled substance analogue “shall, to the extent intended for human consumption, be treated, for the purposes of any Federal law as a controlled substance in schedule I.” But let’s tease it out.

The statutory phrase “[t]reatment as a controlled substance in schedule I” in 21 U.S.C. § 813(a) might suggest that a controlled substance analogue is “controlled.” Therefore, DEA’s statement that cannabinoids “extracted from cannabis with a delta-9-THC concentration less than 0.3 percent … are not controlled under the CSA” could be read as an indication that DEA does not view delta-8 extracted from cannabis having less than .3% delta 9 as controlled under the CSA, either as a controlled substance or analogue. But this isn’t the only possible reading of DEA’s statement—and probably not the better one. A “controlled substance analogue” is treated as a controlled substance only to the extent the analogue is “intended for human consumption.” Delta 8 that is not intended for human consumption is not controlled and can be freely sold or possessed with no CSA ramifications. Without additional context, that is most likely what DEA refers to in the letter: the substance Delta 8 derived from cannabis in a vacuum isn’t controlled. But that doesn’t get us to the core issue: whether delta-8 extracted from cannabis having less than .3% delta 9 and intended for human consumption as a THC substitute is treated as a controlled substance analogue. DEA didn’t answer that question—certainly not with the requisite level of precision to declare delta 8 “legal”—and I read nothing in DEA’s statement that answers the question one way or the other.

Next, consider the argument that the 2018 Farm Bill’s exclusion “tetrahydrocannabinols in hemp” from the definition of THC overrides the more general provisions of the Analogue Act. According to this line of argument, because the 2018 Farm Bill is a more recent law, it supersedes the Analogue Act as a matter of statutory interpretation. This argument is unpersuasive because there is no conflict let alone one that rises to the level of an implied repeal.

Congress removed “tetrahydrocannabinols in hemp” as a controlled substance. But again, whether a “tetrahydrocannabinol in hemp” has the status of “controlled substance” sidesteps the question of whether that same substance could be a “controlled substance analogue.” Under the CSA, a “controlled substance analogue” is not a “controlled substance.” And because the Analogue Act requires that controlled substance analogues be intended for human consumption, there is no conflict at all–certainly not one that would rise to the level of an implied repeal of the Analogue Act. When Congress acted in 2018, it made Delta 8 sourced from cannabis¹ having less than .3% delta 9 an uncontrolled substance, and it allowed Delta 8 to be made, researched, or sold for purposes other than for human consumption free of Schedule I restrictions. But when sold in a form that mimics delta-9 THC for human consumption to get folks high, it remains an analogue.

This is a coherent and logical read of the statute. That Congress expressly maintained cannabis-derived compounds having intoxicating delta-9 THC levels, including delta-9 THC itself, makes it hard to see how Congress intended to legalize sales of a Delta 9 analog—an intoxicating substance it expressly did not remove from control—for human consumption. This is the precise context that the Analogue Act is supposed to address: to give law enforcement flexibility to enforce the spirit of the CSA when the law is slow and the letter of the law results in loopholes that thwart the Congressional design. Delta 8 squarely fits the bill.

Finally, it is important to note that this debate often does not play out on a neutral playing field where the best arguments and evidence prevail. In the arena of administrative law, these battles often get fought against a backdrop of substantial deference to the federal government. For example, under principles of administrative deference, DEA’s construction of the Analogue Act and the CSA might prevail even if it is not the best reading of the statute. To win the day, it often isn’t enough to show that DEA’s reading of the CSA is less persuasive. It must be shown to be unreasonable. I haven’t seen any argument that has come close to meeting this heightened burden.

Two Other Unpersuasive Analogue Act Defenses

One defense to prosecution I’ve seen floated is ignorance. According to this theory, because Delta 8’s status as an analogue is not well-established, a defendant could avoid prosecution by pleading ignorance. Phrased another way, because there is no precedent that Delta 8 is subject to CSA enforcement, an individual defendant can’t be found guilty of an Analogue Act offense, which require knowledge or intentional action.

This line of argument implicates the issue of what level of knowledge the prosecution must prove in an Analogue Act—an issue the Supreme Court addressed in McFadden v. United States, 576 U.S. 186 (2015). In McFadden, the Court explained that in CSA cases bought under 21 U.S.C. § 841(a)(1), the prosecution must show that a defendant knew that the substance with which he was dealing was a controlled substance. In Analogue Act cases, that knowledge can be shown in two ways:

First, it can be established by evidence that a defendant knew that the substance with which he was dealing is some controlled substance—that is, one actually listed on the federal drug schedules or treated as such by operation of the Analogue Act—regardless of whether he knew the particular identity of the substance. Second, it can be established by evidence that the defendant knew the specific analogue he was dealing with, even if he did not know its legal status as an analogue. The Analogue Act defines a controlled substance analogue by its features, as a substance “the chemical structure of which is substantially similar to the chemical structure of a controlled substance in schedule I or II”; “which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than” the effect of a controlled substance in schedule I or II; or which is represented or intended to have that effect with respect to a particular person. § 802(32)(A). A defendant who possesses a substance with knowledge of those features knows all of the facts that make his conduct illegal, just as a defendant who knows he possesses heroin knows all of the facts that make his conduct illegal. A defendant need not know of the existence of the Analogue Act to know that he was dealing with “a controlled substance.”

Ignorance may address the first way of proving knowledge, but it does not address the second. The prosecution can prove knowledge by showing that a defendant knew of the features or characteristics of Delta 8 that makes it a “controlled substance analogue.” And it can do that with direct or circumstantial evidence. In footnote 1 in McFadden, the Supreme Court explained that “[c]ircumstantial evidence could include, for example, a defendant’s concealment of his activities, evasive behavior with respect to law enforcement, knowledge that a particular substance produces a ‘high’ similar to that produced by controlled substances, and knowledge that a particular substance is subject to seizure at customs.”

Case law shows that it doesn’t take much in quality or quantity to carry this burden. For example, in United States v. Requena, 980 F.3d 30 (2d Cir. 2020), the government proved up knowledge by showing that everyone material to a transaction knew synthetic cannabinoids were “sold with the intent that the consumer would ingest it for the purpose of getting high” similar to marijuana. In United States v. Muhammad, 14 F.4th 352, 358 (5th Cir. 2021), the Fifth Circuit found it clear beyond a reasonable doubt that a rational jury would've found that the defendant knew the features that make a-PVP and 4-MEC controlled-substance analogues because the evidence showed that the purpose of his entire operation was to get around the drug laws and that he was familiar with the product he was selling. And in United States v. Novak, 841 F.3d 721 (7th Cir. 2016), the defendant sold XLR-11 as an herbal incense from the back of the store and knew that the herbal incense gave customers a high and believed it was like marijuana.

Given the widespread availability of information about Delta 8 and the all but acknowledged fact that Delta 8 is being sold and used to circumvent the extant legal restrictions on Delta 9, it is difficult to fathom a case that is appropriate to prosecute where the government would have difficulty proving these facts with circumstantial evidence. And it is also worth noting that this “ignorance” type argument runs directly contrary to the core purpose of the Analogue Act: to give law enforcement flexibility to enforce the spirit of the CSA when persons try to avoid its provisions by creating novel compounds. These compounds are by definition novel and untested. If ignorance of controlled substance analogue status or the novelty of the substance provided a valid defense to prosecution, the Analogue Act would have little point.

The other defense is unconstitutionality. This defense is easily dispatched. According to this argument, the substantial similarity requirements in the Analogue Act do not give fair notice. But for the past two decades “courts across the country” that have considered this argument—and there are many—“have held that the Analogue Act is not unconstitutionally vague,” United States v. Gas Pipe, Inc., 2018 WL 5046412, at *3 (N.D. Tex. Aug. 7, 2018), in part due to the intent requirement in proving an offense. The only decision to ever conclude otherwise, to my knowledge, is the district court in United States v. Forbes, 806 F. Supp. 232 (D. Colo. 1992).

Conclusion

DEA’s recent statements provide informal indications of the agency’s view on a narrow question: whether Delta 8 is a controlled substance. But because of the Federal Analogue Act, whether Delta 8 derived from cannabis is a Schedule I controlled substance under the CSA is almost beside the point. It could be argued, persuasively, that Delta 8 intended for human consumption, however derived, is a controlled substance analogue.

Although prosecutions under the Analogue Act are more difficult to prove, proving an Analogue Act offense is not that much more difficult—especially with a body of public statements, research, anecdotes, testimony, and marketing supportive of analogue status growing at a torrid pace. And in a case worthy of prosecution, it is hard to fathom the prosecution having much difficulty coming up with the additional proof.

1. It doesn’t matter where a Delta 8 extract comes from hemp or marijuana as long as it is sourced from cannabis and has a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.

“Tetrahydrocannabinols in hemp” under 21 U.S.C. 812, Schedule I(c) means tetrahydrocannabinols in any part of a cannabis plant, including extracts, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis. Because a Delta 8 extract from marijuana is an extract from a cannabis plant with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis, it is “hemp” and thus, the delta-8 THC in it is a “tetrahydrocannabinol in hemp” and not subject to control. Post 2018 Farm Bill, the Source Rule (i.e., the source of a cannabinoid determines legal status) is no longer a correct reading of the law)