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The Cannabidiol and Marihuana Research Expansion Act (S. 253)
A counterproductive proposal that must be stopped
Yesterday, the Senate unanimously approved the so-called “Cannabidiol and Marihuana Research Expansion Act.” The bill’s sponsors—Sens. Dianne Feinstein (D-CA), Brian Schatz (D-HI) and Chuck Grassley (R-IA)—took to social media to tout the bill’s passage as a major victory for those seeking to remove barriers to marijuana research. In fact, however, S. 253 is a counterproductive nightmare. If enacted, it would make marijuana research harder—not easier. I’ll highlight just a few of the bill’s most problematic provisions here.
Sec. 2. Definitions
Let’s start with the bill’s definition of “cannabidiol,” which I’ve reproduced in full here:
The problem with this definition is that it makes the bill’s cannabidiol provisions nonsensical at best or counterproductive at worst depending on whether the “substance … cannabidiol” or the “marihuana” from which it is derived must have a delta-9 THC “level that is greater than 0.3 percent.” If the “substance … cannabidiol” must have a delta-9 THC “level” greater than 0.3%, then all “cannabidiol” is also schedule I “marihuana,” and the bill’s various provisions treating “cannabidiol” and “marihuana” separately are nonsensical. See 21 U.S.C. 802(16) (defining “marihuana” (with a few exceptions not relevant here) as any part of the cannabis plant with a delta-9 THC concentration of 0.3% or more on a dry weight basis).
If the “marihuana” from which the “substance … cannabidiol” is “derived”—and not the “substance … cannabidiol” itself—must have a delta-9 THC “level that is greater than 0.3 percent,” by contrast, the bill’s cannabidiol provisions make cannabidiol research harder than it is under current law. Because cannabidiol under that reading wouldn’t exceed the 0.3% delta-9 THC threshold, it would qualify as “hemp”—not “marihuana”—under federal law. Hemp isn’t a controlled substance, meaning researchers seeking to study it face none of the regulatory barriers applicable to schedule I “marihuana.”
Ironically, that means the bill’s “cannabidiol” provisions—the ones the bill’s sponsors say will encourage cannabidiol research—would actually severely restrict cannabidiol research. To pick just one example, consider Sec. 201, titled “Medical Research On Cannabidiol.” That provision would permit any “appropriately registered covered institution of higher education, a practitioner, or a manufacturer” to handle cannabidiol “for purposes of medical research for drug development or subsequent commercial production ….” In other words, the bill would require anyone seeking to handle cannabidiol for research and development purposes to register with DEA—an extraordinary regulatory burden not applicable to cannabidiol research and development under current law.
The terrifying reality is that this bill is the handiwork of someone (or some group of people) who does not understand even the most basic concepts like “What is marijuana?” “What is hemp?” “What is cannabidiol?” etc.
Sec. 103. Applications to Manufacture Marihuana for Research
This is one of several sections of the bill that would make researching marijuana even harder than it is under federal law right now. It would amend 21 U.S.C. 823 by, among other things, adding the following provision
This amendment would give DEA unreviewable authority to avoid licensing any marijuana manufacturers at all simply by refusing to place a notice in the federal register seeking more applications. DEA doesn’t have that sort of power over any application to register as the Controlled Substances Act is written today.
Another provision would limit registered marijuana manufacturers to growing for use in FDA studies. See Sec. 103(C)(1)(B)(iii). This, too, would be more restrictive than current law. Indeed, DEA recently acknowledged in a final rule that registered growers may cultivate marijuana for research and product development. See, e.g., 85 Fed. Reg. 82333, 82333-34 (Dec. 18, 2020) (Thus, any person who seeks to plant, cultivate, grow, or harvest marihuana to supply researchers or for other uses permissible under the CSA (such as product development) must obtain a DEA manufacturing registration.”).
Yet another provision would render any application to register to manufacture marihuana incomplete—meaning DEA would have unreviewable discretion to deny it out of hand—unless and until the applicant “submit[s] documentation showing” that they will get DEA’s “prior, written consent” before “transfer[ring] … any marihuana manufactured under this subsection.” Once again, this is more restrictive than current law. Neither the Controlled Substance Act nor DEA regulations have ever contained a similar requirement.
I could go on. How anyone could think provisions like these would expand marijuana research is difficult to fathom.
The bill imposes various deadlines for DEA to process applications. Trouble is, because the bill fails to specify the consequences of DEA’s failure to meet them, none of them would be enforceable in court. See, e.g., Transportation Div. v. Fed. R.R. Admin., 10 F.4th 869, 874 (D.C. Cir. 2021) (“[I]f a statute does not specify a consequence for noncompliance with statutory timing provisions, the federal courts will not in the ordinary course impose their own coercive sanction.”) (quoting Barnhardt v. Peabody Coal, 537 U.S. 149, 159 (2003)).
Phrased in this way, deadlines will be toothless. Notably, this problem infects every deadline in the bill.
S. 253 is a very bad bill. It is nonsensical and self-defeating. It must be stopped. As I’ve explained over and over, the Controlled Substances Act gives DEA vast authority to green light as much marijuana research as it wants, any time it wants. The primary problem isn’t any lack of statutory flexibility. It’s lack of funding. DEA has licensed multiple cannabis growers and researchers, and I know for a fact that they are eager to conduct the serious scientific research into cannabis’s medical utilities and risks that has been so urgently needed for so many decades. But serious clinical research costs tens if not hundreds of millions of dollars to complete. Without funding from the public or private investment, it simply cannot happen.
If Congress wants to help, it should consult people who understand the law in this area (like, I don’t know, Matt Zorn or yours truly among others). If it’s not going to do the work necessary to understand the basics, it should stop pretending it takes this stuff seriously.