Related: What Rescheduling Still Doesn’t Fix for Probationers, Workers, and Patients

The short version: Mikos made two predictions in 2024: rescheduling might not happen (or might not last), and even if it did, it would not much improve the state-licensed industry’s position because the Controlled Substances Act’s Schedule III rules and the Federal Food, Drug, and Cosmetic Act (FDCA) would still apply. The one clear benefit he identified was tax relief under Section 280E. The April 2026 order tracked some of those predictions closely and departed from others in ways that matter for South Dakota.

Robert A. Mikos, the LaRoche Family Chair in Law at Vanderbilt University Law School, has been a prominent skeptic of marijuana rescheduling. His article “The False Promise of Rescheduling,” published in the Tulsa Law Review and based on his keynote at the journal’s March 2024 symposium, challenges the optimism that moving marijuana to Schedule III would be a game-changer for the industry.¹

He wrote it before any federal rescheduling action was final. He was candid that “there have been many developments in the rescheduling saga since I wrote the first draft,” but he concluded that his “bottom-line assessment remains fundamentally sound: The impact of rescheduling will be muted, and it will take Congressional legislation to deliver the more sweeping reforms the vast majority of Americans now want.”²

That bottom line is worth testing now that DEA has acted. The April 28, 2026, order moved marijuana, marijuana extract and naturally derived delta-9 THC to Schedule III only when they are in FDA-approved products or “subject to a state medical marijuana license”; synthetic THC remains in Schedule I.³

The core thesis

Mikos calls his article “a reality check.” He argues that expectations around rescheduling were “greatly inflated” for two reasons. First, “the DEA might yet refuse to reschedule marijuana,” or a later administration could undo it. Second, “even assuming marijuana is rescheduled and stays off Schedule I, the change still will not significantly improve the fortunes of the marijuana industry.”⁴

His closing message is that agencies cannot fix federal marijuana policy on their own: “Meaningful reform requires Congressional action.”⁵

Argument 1: It relies on a new reading of “accepted medical use”

For decades, the barrier to moving marijuana off Schedule I was a single requirement. DEA insisted that a drug must have a “currently accepted medical use” (CAMU) to leave Schedule I, and that the way to show it, short of FDA approval, was a five-part test requiring adequate and well-controlled studies, meaning randomized controlled trials. In Mikos’ summary: “no RCTs, no CAMU; and, no CAMU, no rescheduling.”⁶

In 2023, HHS concluded for the first time that marijuana has a CAMU, without RCTs. It applied a new two-part test: widespread physician- and state-approved therapeutic use, plus “some credible scientific support” that the use works for at least some conditions. Mikos’ gloss: “no RCTs, no problem.”⁷

He argued that this made rescheduling fragile. Because HHS’s change was arguably a legal reinterpretation rather than a scientific finding, he wrote, DEA might not be bound to accept it, and a future administration could cite the old test to move marijuana back.⁸

Argument 2: DEA might go another way, including through the treaty provision

Mikos flagged a second route DEA could take: 21 U.S.C. § 811(d)(1), which directs scheduling to satisfy treaty obligations “without regard to the findings” normally required. DEA had previously argued that international drug treaties required production quotas that the CSA imposes only on Schedules I and II, so treaties set a Schedule II floor. On that reasoning, he warned, DEA could move marijuana to Schedule II rather than III.⁹

Argument 3: Schedule III still carries most of the CSA’s burdens

Even in Schedule III, Mikos wrote, “the CSA will impose a litany of restrictions on the manufacture and sale of marijuana”:¹⁰

  • Producers and distributors need a DEA registration.
  • DEA “is likely to refuse registration to any firm that operates in the recreational (i.e., adult-use) marijuana market because the CSA bans the production and sale of controlled substances for non-medical purposes.” He noted DEA could also refuse registration to firms controlled by people with prior drug convictions, which could hit social equity licensees.
  • Registrants would have to stop buying from, or selling to, companies that are not registered with DEA.
  • Registrants would have to comply with federal handling, labeling, packaging and tracking rules that may differ from state rules.
  • “[F]ew, if any, of the more than 12,000 companies now licensed by the states to produce and/or sell marijuana will be able and willing to scrupulously comply.”

For companies that don’t comply, he wrote, the old problems remain: the same criminal sanctions, money that still counts as “the proceeds of specified unlawful activity” under federal money laundering law, unregistrable trademarks, no bankruptcy reorganization and unenforceable contracts.¹¹

Argument 4: Section 280E is the one real exception

It’s easy to assume Mikos dismissed the tax benefit along with most of the claimed benefits. He didn’t.

Mikos wrote that the industry’s challenges “will persist post-rescheduling, with only one exception—Section 280E,” because that tax provision applies only to trafficking in Schedule I and II drugs. “Indeed, for this reason, even unlicensed marijuana dealers will get a tax break from rescheduling.”¹² His conclusion: “rescheduling may amount to no more than a tax cut for marijuana suppliers, licensed or otherwise.”¹³

In other words, he treated 280E relief as real, and as nearly the only real benefit.

Argument 5: The FDCA problem doesn’t go away

Rescheduling under the CSA does nothing to the FDCA. “Marijuana is an unapproved drug, and it would remain so even if it were descheduled under the CSA,” Mikos wrote. HHS “repeatedly emphasized” that its CAMU finding did not mean safety and effectiveness had been established for FDA approval.¹⁴

He argued that state-licensed sellers cannot easily avoid the FDCA by staying in-state, because FDA reads its jurisdiction to reach products with components shipped across state lines, such as packaging, cartridges or extraction solvents. One nuance cuts the other way on banking: FDCA violations, unlike CSA violations, are not “specified unlawful activity” under the money laundering statute, which gives banks “one less reason” to avoid CSA-compliant companies.¹⁵

Argument 6: Meaningful reform takes Congress

Mikos’ normative point is that the administrative route has been oversold, and that continuing to push it “may simply distract from the unavoidable, if inconvenient, truth: Meaningful reform requires Congressional action.” He notes that Congress passed the CSA, placed marijuana on Schedule I, designed the scheduling process and wrote international law into it.¹⁶

How the April 2026 order tests the argument

The final order DEA issued in April 2026 is not the proposal Mikos was analyzing when he wrote. Here is how his predictions compare with its text.

The treaty route was used, but not the way he warned it might be. The order relied on § 811(d)(1) and was issued “without regard to the findings required by [21 U.S.C. 811(a) or 812(b)].”¹⁷ It did not set a Schedule II floor. It placed in Schedule III only covered FDA-approved products and marijuana, marijuana extract and naturally derived delta-9 THC subject to a state medical marijuana license, and it added a provision addressing compliance with Article 23 of the Single Convention for entities holding valid licenses under the new paragraph.¹⁸ That changes the CAMU fight he described: the order noted HHS’s 2023 recommendation but relied on § 811(d)(1), which allows scheduling to meet treaty obligations “without regard” to the usual findings.

The scope is narrower than he assumed. Mikos was analyzing a rescheduling of marijuana generally. The order reaches only marijuana, marijuana extract and naturally derived delta-9 THC in FDA-approved products or “subject to a state medical marijuana license.”³ Synthetic THC remains in Schedule I, and everything outside the covered categories, including adult-use marijuana, was not moved by the order.

DEA addressed some compliance burdens directly. The order directs an expedited registration process for state medical marijuana licensees, treats a state license as “conclusive evidence” of state authorization, says DEA will “accept state-required reports, records, and forms to the maximum extent permissible,” and allows dispensing based on a state-law certification or other qualifying document “[n]otwithstanding part 1306.”¹⁹ The same framework ties federal status to state status: DEA registration is automatically suspended if the state license is suspended, revoked or expires. Those features respond to several of the burdens Mikos listed. Whether they work in practice depends on how many state licensees actually register.

His adult-use prediction held. The order says registrations “do not authorize the manufacture, distribution, dispensing, or use of marijuana or products containing marijuana for non-medical purposes.”²⁰

His 280E point mostly held, with a twist. The order states that “holders of state medical marijuana licenses will no longer be subject to the deduction disallowance imposed by Section 280E,” while adding that “[n]othing in this rule constitutes a determination regarding federal tax liability.”²¹ In my reading, the narrow scope changes one of his specific claims: because adult-use and unlicensed marijuana were not moved out of Schedule I by this order, his statement that “even unlicensed marijuana dealers will get a tax break” does not describe this order.

The FDCA was not addressed. The order does not resolve the FDCA issues Mikos described. The order does not address FDA approval, so to the extent state-licensed marijuana products are not FDA-approved, Mikos’ FDCA concern remains.

The reversal risk looks different. Mikos worried that a new administration could undo a Biden-era rescheduling. The April 2026 order came from the administration he identified as a possible source of reversal. A future administration could still revisit it, but the political risk he described has changed shape.

What it means in South Dakota

South Dakota’s program is medical-only, so the adult-use exclusion matters less here than in states such as Colorado. The questions that matter are the ones Mikos would ask about compliance: whether South Dakota’s licenses qualify as “state medical marijuana licenses” under the order, how many South Dakota businesses seek DEA registration, and whether small operators can carry the federal paperwork. WeedPress has covered related South Dakota questions, including the state’s registration certificates and the small-operator compliance cliff.²²

The FDCA issue applies in South Dakota as it does elsewhere. And Mikos’ bottom line applies too: the order changed the tax picture and created a federal path for medical licensees, but it did not deschedule marijuana or authorize nonmedical commerce. Congress still holds the pen on broader reform.

Related coverage

Notes

¹ Robert A. Mikos, The False Promise of Rescheduling, 60 Tulsa L. Rev. 1, 1 n.* (2024), https://digitalcommons.law.utulsa.edu/tlr/vol60/iss1/6; see also SSRN, https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4814284.

² Id. at 1 n.*.

³ Schedules of Controlled Substances: Rescheduling of Food and Drug Administration Approved Products Containing Marijuana From Schedule I to Schedule III; Corresponding Change to Permit Requirements, 91 Fed. Reg. 22714 (Apr. 28, 2026), https://www.federalregister.gov/documents/2026/04/28/2026-08176/schedules-of-controlled-substances-rescheduling-of-food-and-drug-administration-approved-products.

⁴ Mikos, supra note 1, at 3–4.

⁵ Id. at 24.

⁶ Id. at 2, 6–8.

⁷ Id. at 8–10.

⁸ Id. at 12–14, 18.

⁹ Id. at 14.

¹⁰ Id. at 4, 20–21.

¹¹ Id. at 21–22.

¹² Id. at 19–20.

¹³ Id. at 23.

¹⁴ Id. at 22.

¹⁵ Id. at 22–23.

¹⁶ Id. at 23–24.

¹⁷ 91 Fed. Reg. 22714 (quoting 21 U.S.C. § 811(d)(1)).

¹⁸ Id. at 22721–22 (to be codified at 21 C.F.R. § 1301.13(k)(6)) (Article 23 of the Single Convention on Narcotic Drugs).

¹⁹ Id. at 22721–22 (to be codified at 21 C.F.R. § 1301.13(k), (k)(2), (k)(4), (k)(5)).

²⁰ Id. (to be codified at 21 C.F.R. § 1301.13(k)(1)(iv)).

²¹ Id. at 22720.

²² See Jason Karimi, The April Rescheduling Order Asks for a License. Pierre Issues Four Certificates, WeedPress (Sept. 11, 2026), https://weedpress.org/2026/09/11/the-april-rescheduling-order-asks-for-a-license-pierre-issues-four-certificates/; Jason Karimi, South Dakota Small Cannabis Operators Face a Compliance Cliff, WeedPress (June 7, 2026), https://weedpress.org/2026/06/07/south-dakota-small-cannabis-operators-face-a-compliance-cliff-federal-rescheduling-likely-to-drive-more-closures-and-force-consolidation/.

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Jason Karimi, publisher of WeedPress

Jason Karimi, Publisher

Jason Karimi is the publisher of WeedPress and a medical cannabis patient who has covered cannabis law and policy since 2009.

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