Over the past three decades, advocates have convinced a growing number of states to authorize the medical use of drugs that lack Food and Drug Administration (FDA) approval. To date, forty-one states have legalized the medical use of marijuana, and at least three states have legalized therapeutic use of psilocybin. The passage of these state reforms—a phenomenon I refer to as “drug law federalism”—has proven surprisingly impactful. Millions of people are now using these drugs for therapeutic purposes pursuant to state authorization, notwithstanding the fact that the FDA has not yet found them to be safe and effective for treating any indication. 

While advocates have praised states for serving as the laboratories of democracy, our drug law federalism carries a hidden cost: State drug reforms can mislead consumers about the safety and efficacy of a drug, causing them to make poorly-informed decisions about drug use in treatment.

How State Drug Reforms Mislead Consumers

State drug reforms could mislead consumers in two distinct ways. First, the political campaigns that are waged to win passage of state reforms could lead consumers to form overly positive assessments of a drug’s efficacy and safety. Advocates of reform have an obvious incentive to tout the benefits of a drug, without acknowledging limitations in the scientific support for such benefits, while also downplaying the drug’s potential harms. After all, voters who are made to believe that a drug works well and is safe will naturally be more inclined to support a proposal to grant more access to it.

The campaign behind Oregon’s 2020 Measure 109 is illustrative. The measure legalized the therapeutic use of psilocybin under Oregon law. At the time of the election, there was some scientific research suggesting that psilocybin could be effective at treating depression and other psychiatric disorders. But the power of these studies was limited by several shortcomings, including small numbers of subjects, a lack of adequate controls, and unsuccessful blinding of subjects and researchers. Nonetheless, advocates confidently touted the drug’s safety and efficacy in the campaign to get Measure 109 passed. Consider some representative statements made during the campaign: 

“Rigorous studies at leading medical research institutions such as Johns Hopkins, UCLA, and NYU show that psilocybin therapy works. It is uniquely effective in treating depression, end-of-life anxiety, and addiction.” (Yes on IP 34 Campaign FAQ) 

“Research shows [psilocybin] could provide tremendous positive impacts for people suffering from mental health challenges including trauma, depression, anxiety, and more.” (Law Enforcement Action Partnership, 2020 Oregon General Election Voters Pamphlet Book)

“[T]he benefits that will be gained for those suffering from depression, anxiety, and substance abuse clearly outweigh the majority of concerns.” (Portland Mercury Editorial Board Endorsement of Measure 109)

Although ostensibly aimed at winning more votes for a proposed reform, such claims could also influence the treatment choices consumers make after the votes are counted. Ceteris paribus, a consumer who has been exposed to a campaign touting the safety and efficacy of a drug is more likely to want to try that drug. Indeed, pharmaceutical companies spend billions annually on commercial advertising because they know such campaigns stimulate consumer demand for their products. The simple observation I make here is that political advertising campaigns could have the same effect as commercial advertising campaigns: both could boost consumer demand for a drug. 

Unlike commercial advertising, however, political advertising lacks the regulatory safeguards that help protect consumers from false, misleading, or vague factual claims. The FDA and Federal Trade Commission closely scrutinize the claims that drug companies make in commercial advertisements. The agencies order firms to pull advertisements when they include unsubstantiated claims of efficacy or fail to adequately disclose the risks surrounding use of a drug. For example, the agencies would likely order a pharmaceutical company to pull an advertisement claiming its unapproved psilocybin product was “uniquely effective” at treating depression because that claim has not yet been adequately substantiated. But neither the FDA nor any other federal agency reviews the factual claims advocates assert in political campaigns, including claims concerning the benefits and risks of using a particular drug. The lack of regulation increases the risk that consumers could be misled by the political campaigns behind state drug reforms. 

State drug reforms can distort consumer perceptions for a second reason as well: people may think that a drug is safe and effective precisely because the state has authorized its use. I have previously explained how state medical marijuana reforms arguably generate a halo effect around that drug: “By declining to punish marijuana use, especially after banning it for so long, the states are arguably suggesting that marijuana use is safe, beneficial, and not wicked.” The same could be said of reforms that remove state prohibitions on other drugs as well.

Two features of recent state drug reforms arguably help to reinforce the perception that state-authorized drugs are safe and effective. First, state reforms commonly declare them to be so. The preamble to Oregon’s Measure 109, for example, proclaims that “Studies conducted by nationally and internationally recognized medical institutions indicate that psilocybin has shown efficacy, tolerability, and safety in the treatment of a variety of mental health conditions, including but not limited to addiction, depression, anxiety disorders, and end-of-life psychological distress.” In other words, the reform appears to endorse the bold claims made by advocates during the election (discussed above).

Second, state drug reforms commonly mimic the appearance of FDA drug approval by authorizing use of a drug to treat specific medical conditions. To illustrate, compare the FDA’s approval of Epidiolex with Oregon’s Measure 67, which authorized the medical use of marijuana in that state. Epidiolex is an oral solution containing cannabis-derived CBD. In 2018, the FDA approved Epidiolex for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. That approval was based on large, randomized controlled trials (RCTs) which demonstrated that Epidiolex is safe and effective for use with those three specific indications. Measure 67 followed a similar approach for marijuana. It authorized the use of that drug to treat eight specific indications: cancer, glaucoma, HIV/AIDS, severe pain, severe nausea, cachexia, seizures, and persistent muscle spasms. This limitation implies there is strong evidence demonstrating that marijuana is safe and effective at treating each of those eight conditions. After all, why bother to limit use of the drug unless there is a good reason for doing so. But to this day—let alone in 1998 when Measure 67 was passed—there are still no RCTs demonstrating that marijuana is safe and effective at treating any of the eight conditions listed by Measure 67 (or any others). 

It is, of course, a mistake for anyone to equate state legalization with an endorsement of a drug’s safety and efficacy or as the equivalent of FDA approval. The decision to legalize drugs at the state level is made by political actors, the people themselves, or perhaps their elected representatives. The FDA, by contrast, employs neutral, scientific experts to make drug approval decisions. Science might play a role in the passage of state reforms, but as discussed above, scientific claims made during that process are not vetted for accuracy. Furthermore, state drug reforms might pass for a variety of reasons wholly unrelated to scientific assessments of safety and efficacy, including a desire to protect personal autonomy. By contrast, the FDA drug approval process focuses exclusively on science and what it tells us about a drug’s potential risks and benefits. While not perfect, successful completion of that process indicates that a drug is safe and effective for a specific, intended use; the passage of a state drug reform does not. But the reality is that consumers might mistakenly perceive the two as equivalents and make their treatment choices accordingly. 

A quick clarification. Although I have focused on how drug law federalism could lead consumers to overestimate the likely benefits of a drug or underestimate its harms, I recognize that drug law federalism could produce the opposite effect. Opponents of reform might wage political campaigns that exaggerate a drug’s harms or downplay its benefits, leading consumers to misjudge a promising drug as snake oil (or worse). Likewise, before a reform passes, consumers might wrongly believe that a drug must be ineffective and harmful just because the state has banned it. However, whether drug law federalism causes consumers to form unduly positive or unduly negative assessments of a drug is largely beside the point, for present purposes. The harm in either case is identical: To the extent drug law federalism distorts their perceptions of safety and efficacy, consumers will make poorly informed decisions about drug use.

What can be done to protect consumers from being misled?

State drug reforms include some measures that could help correct the misperceptions caused by political campaigns or the passage of reform. Most notably, reforms commonly require consumers to consult with a gatekeeper before they use a drug. In theory, the gatekeeper could use the opportunity to debunk any unfounded beliefs a consumer might have about the potential harms and benefits of a drug. In practice, however, gatekeepers are not necessarily well-prepared for this task. While many medical marijuana states require patients to consult with a licensed health care professional (e.g., a physician), these HCPs usually have no formal training on the medical use of marijuana, and there is no FDA approved Prescribing Information on marijuana for them to consult. Some reforms employ gatekeepers with even less training. Oregon’s Measure 109, for example, uses “psilocybin service facilitators” as gatekeepers. Because the state requires only minimal qualifications to serve as one (e.g., a high school diploma and a certificate from a months-long training program), these facilitators are not necessarily HCPs. Furthermore, the consultation between gatekeepers and consumers can be perfunctory. In medical marijuana states, the HCP need only diagnose a patient with a qualifying condition and certify that the patient “may benefit” from marijuana; they are actively discouraged from recommending any particular strain, dose, or mode of administration to the patient, in order to minimize their exposure to federal sanctions. In Oregon, Measure 109 gives facilitators almost unfettered discretion to decide for themselves whether a client will be allowed to use psilocybin; e.g., they do not need to make any particular diagnosis (they would not necessarily be qualified to make one anyway). It is telling that in 2025, facilitators rejected for any reason only about 4.3% (258/5,935) of client requests for a psilocybin session. 

The lack of robust consumer protection in state laws suggests that federal intervention may be warranted, but the federal government’s options are limited. Congress cannot simply block states from authorizing the use of a drug, even one that is prohibited by federal law. This important limitation on federal supremacy stems from the Supreme Court’s anti-commandeering rule. In relevant part, this constitutional doctrine bars Congress from ordering a state to enact a law regulating private citizens, such as a law prohibiting them from using a drug. State authorization is the antithesis of regulation. When a state authorizes the use of a drug, it repeals a regulation it had no obligation to adopt in the first instance. For example, at its core, Measure 109 removed Oregon’s prohibition on the possession of psilocybin in service centers. Since Congress could not force Oregon to adopt that prohibition, then, logically, it also could not prevent Oregon from repealing it decades later. 

Of course, the anti-commandeering rule does not stop the federal government from imposing its own prohibition on the use of a drug. But because the Drug Enforcement Administration and the FDA have very limited enforcement resources, federal prohibitions may not be effective at changing consumer drug behaviors. As I have observed elsewhere, for example, “[m]ost medical marijuana users and suppliers can feel confident they will never be caught by the federal government.” In any event, criminal prosecutions are a heavy-handed way for the federal government to redress concerns over consumer confusion, especially when those prosecutions are directed at users. 

Neither can Congress stop advocates from making drug claims in their political campaigns, even though it may bar similar claims made in commercial advertising campaigns. Political speech, including advertisements directed at a state ballot proposal, is entitled to far more constitutional protection under the First Amendment than is purely commercial speech. Hence, a federal law banning factual claims about drugs made as part of a political campaign would be unconstitutional and void, even if those claims were blatantly misleading.

But the federal government does have one option at its disposal. It could wage its own public information campaign to counter misinformation and better educate consumers about the risks and benefits of using unapproved psychedelics (and other drugs). The FDA is well-suited for this task. As a trusted “custodian of knowledge”, the agency can explain to the public “what science knows and how it knows it.” For example, it could run its own advertising campaign (before or after the passage of a state reform) to provide consumers with a neutral, expert assessment of what existing research shows (and doesn’t yet show) about the safety and efficacy of using psychedelics to treat various medical indications. Of course, the efficacy of this counter-speech strategy hinges on the agency’s credibility, which has been slipping. But the hope is that the FDA could help consumers make better-informed decisions about using psychedelics.

Conclusion A growing number of states have authorized therapeutic use of drugs that have not yet been (and might never be) FDA-approved. While advocates have praised the states for serving as the laboratories of democracy, the subjects of these state experiments may not fully understand the potential benefits and risks of the drugs they are taking. The campaigns behind reforms and the reforms themselves could lead consumers to overestimate a drug’s potential benefits or underestimate its potential harms. The FDA should step in to help counter misinformation and correct misperceptions surrounding unapproved drugs.

Robert A. Mikos holds the LaRoche Family Chair in Law at Vanderbilt University Law School. He is one of the nation’s leading experts on federalism and drug law.