Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Mushroom Monographs? The FDA’s Potential Role in a Legal Recreational Drug Market

By Jonathan Perez-Reyzin

Within the psychedelic legal landscape, the U.S. Food and Drug Administration (FDA) plays a central role — it is the regulatory mechanism by which drugs like MDMA and psilocybin may soon become legal for medical use.

But for many working in drug policy, medicalization is not the exclusive goal. Indeed, there have been calls for legalization of psychedelics for non-medical use — and we are seeing an early attempt at such a model in Oregon.

These efforts are not yet reaching the federal level, but it’s only a matter of time before the legalization of psychedelics and other currently illegal drugs for adult recreational use becomes a federal question, as is already occurring with marijuana. And despite the FDA’s widely recognized role in medicine, few have considered the role the FDA would play in a federal regulatory regime for the non-medical use of drugs, even though it already does regulate at least one recreational substance legal for recreational use: tobacco.

But the FDA’s path to regulating tobacco was anything but straightforward, and the other major federally legal recreational drug — alcohol — is largely exempt from the FDA’s authority. At least two questions are thus presented for those interested in any sort of recreational (i.e., non-medical) drug legalization:

  • Does the FDA have the existing authority to regulate illicit drugs, should they become legal for adult recreational use?
  • How should the FDA regulate recreational drugs, if it has the power to do so?

Answering these questions is essential to envisioning a post-prohibition world in which drug users’ safety is protected, and drug users’ choices are respected.

The FDA’s Existing Authority

Before the passage of the federal Controlled Substances Act in 1970 and the creation of the DEA, the FDA actually did play some role in regulating recreational drugs — indeed, for a brief period, the FDA’s authority extended to hallucinogens. But such explicit regulatory authority has mostly been displaced by the DEA’s primary authority over drug scheduling, leaving the question of what power the FDA would have if a DEA-controlled drug were removed from the controlled schedules unanswered in practice.

Under the present language of the Food, Drug, and Cosmetic Act (“FDCA”), drugs over which the FDA has authority are defined, in part, as articles “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” or articles “intended to affect the structure or any function of the body.” The “structure/function” definition would seem plainly to apply to recreational drugs, but it would also seem to apply to innumerable non-drug items, such as the winter coat one puts on to survive a New England winter, over which few would argue the FDA has any authority. As a result, the scope of the FDA’s authority has largely been left up to courts’ interpretations of this broad structure/function language.

On one hand, FDA’s most (in)famous attempt to control a recreational drug under its existing statutory authority failed. In FDA v. Brown & Williamson Tobacco Corp., the Supreme Court ruled that Congress had not intended to allow FDA to regulate tobacco products. It was only after Congress gave the FDA explicit authority over tobacco nearly ten years later that the FDA was able to begin regulating it. On the other hand, relying on its power to define drugs and devices, the FDA has indeed successfully asserted authority over some recreational drug use. In United States v. Travia, for example, a court upheld a criminal complaint under the FDCA for selling nitrous oxide (laughing gas). Most significantly, the court held that the nitrous oxide in question was a “drug” under the “structure/function” definition of the FDCA. An earlier case held that a “cocaine substitute” sold as incense was a drug under the meaning of the FDCA, and the FDA continues to consider “street drug alternatives” to be unapproved new drugs and misbranded drugs. However, all of these recreational drug regulatory successes share a common factor: they are not attempts at regulation so much as they are attempts at prohibition, in which the FDA is merely seeking injunctions or convictions to stop manufacturers and distributers. At least one author has pointed to the FDA’s regulation of certain drugs intended for cosmetic use as (like hair growth drugs) as evidence that it may assert its regulatory authority over non-therapeutic — including recreational — uses of drugs, but the FDA has not yet attempted to create a regulatory regime for non-tobacco recreational drugs.

This lack of clarity may end up mattering little, because Congress will likely speak to the FDA’s role in any legislation legalizing recreational substances. Two competing pieces of federal marijuana legislation, the Democrat-sponsored Marijuana Opportunity Reinvestment and Expungement Act and the Republican-sponsored States Reform Act, envision roles for the FDA, albeit very different ones, with the latter bill limiting its authority to the authority “it has with respect to alcohol and no more” (i.e., essentially no authority). But given the possibility that the FDA will have at least some authority over a future recreational drug market, the question of how FDA should regulate recreational drugs is essential for the agency, legislators, and the public to begin answering now.

Challenges for the FDA

The how of FDA recreational drug regulation is not a simple question, and I will gesture at only one of its major challenges here. Traditionally, the FDA regulates drugs via a process in which it evaluates whether a drug is “safe and effective” for its intended use. The pitfalls of this approach are immediately evident — the effectiveness of recreational drugs is not easily measurable, and even potentially “unsafe” recreational drugs may nevertheless be legal. Indeed, in denying the FDA authority to regulate tobacco, the Supreme Court noted that, if the FDA were to use its standard process, it would have to conclude that tobacco is unsafe and ban it. More generally, adult consumers are empowered to make plenty of decisions about whether a pleasurable experience — like driving a classic car without seatbelts or airbags — is worth the safety risk. Many would presumably object to the FDA deciding that a newly legal drug is insufficiently pleasurable to be worth its risks and removing it from the market.

As a result, when Congress ultimately gave the FDA the explicit authority to regulate tobacco, it created a new system — instead of evaluating “safety and effectiveness,” the FDA would employ a “public health” standard. This allows the FDA to regulate the risky product without banning it outright. Although the FDA’s regulation of tobacco has not been without its challenges and criticisms, the public health standard could serve as a guide to future models for recreational drug regulation. A guiding standard, of course, is just a start — details like whether the FDA should require a lengthy premarket review and a prescription for every recreational drug product, or whether it would be better served by adopting a more flexible regulatory framework (like the monograph system for over-the-counter drugs) will certainly have to be worked out, too. But beginning to deal with the details now will facilitate a smoother and healthier transition away from the war on drugs.

Jonathan Perez-Reyzin

Jonathan Perez-Reyzin is a J.D. Candidate at Yale Law School and an affiliated researcher with the Petrie-Flom Center's Project on Psychedelics Law and Regulation (POPLAR).

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