Regulating Psilocybin as Food, Not Drugs

Psilocybin should be regulated under food law rather than drug law. Doing so would serve public health, individual autonomy, and regulatory coherence.

Scientific consensus supports this shift. When researchers ranked 20 substances by overall harm to users and society, alcohol scored highest and psilocybin scored lowest.

Yet, federal law flips this reality. Congress explicitly exempted alcohol and tobacco from the Controlled Substances Act (CSA), regulating them as tax-generating commodities, despite the fact that alcohol and tobacco together kill more than 650,000 Americans annually. 

Conversely, the Drug Enforcement Administration classifies psilocybin as Schedule I: unsafe, no accepted medical use, and high abuse potential. It shares this designation with heroin. 

The distinction between “food” and “drug” in American law is a political artifact, not a clear pharmacological boundary. Psilocybin has been used by indigenous cultures for millennia. We regulate lethal intoxicants as age-restricted consumer products while banning a substance recognized by experts and users alike to be far safer. Psilocybin should be regulated under the dietary supplement framework with adult-use restrictions – similar to how we treat alcohol and tobacco.

The Limits of Drug-Centric Regulation 

A “drug” in the modern pharmaceutical model is a tool to treat a specific illness, accessed through a doctor, validated by clinical trials. 

Psilocybin sits uneasily within this paradigm. While there is some evidence it shows promise for depression, many documented benefits — enhanced well-being, creative insight, spiritual experience — do not map onto FDA disease categories. The drug framework offers no path for the “well” person seeking psychological exploration.

Forcing the broad potential benefits of psilocybin into a narrow medical channel is problematic, and FDA’s recognition of psilocybin’s medical potential exacerbates the problem. Under the “drug exclusion clause,” once substantial clinical investigations begin, a substance is often legally barred from being sold as a dietary supplement, closing the very pathway that could accommodate non-medical use. The more evidence supports medical use, the more firmly the drug exclusion clause locks the substance into pharmaceutical channels.

Regulating psilocybin as a food breaks this deadlock. While drug laws ask, “Is this patient sick enough?” food law asks, “Is this product safe enough?” This framework prioritizes protection. Regulators may still implement guardrails, including age limits, retail licensing, and dosage caps (as with alcohol), and labelling restrictions and adulterant testing (as with supplements).

Consciousness-Altering Commodities

U.S. food law already governs substances that alter mood and cognition through non-pharmaceutical frameworks. Caffeine, alcohol, and nicotine are regulated as consumer products despite their psychoactive effects – a distinction rooted in historical and cultural factors rather than relative safety profiles.

The CSA explicitly exempts “distilled spirits, wine, malt beverage, nicotine, or tobacco.” This exists despite alcohol’s neurotoxicity and the Supreme Court’s finding in FDA v. Brown & Williamson (2000) that tobacco products would otherwise meet the statutory definition of “drug.” These are regulated as adult-use commodities subject to taxes and labeling standards, not medical gatekeeping.

Having no pathway for low-risk psilocybin creates regulatory confusion, just as it has in the case of hemp-derived cannabinoids (CBD). FDA maintains CBD cannot be lawfully marketed as food — invoking the drug exclusion clause — but FDA undertakes minimal enforcement. Thus, CBD is a legitimate pharmaceutical (Epidiolex), an illegal food adulterant, and a ubiquitous consumer product.

Food Regulation as Alternative Framework

The critical distinction between “food” and “drug” turns on intended use. Under the doctrine from Nutrilab v. Schweiker, classification depends on marketing and positioning, not inherent molecular properties.

Psilocybin marketed for “major depressive disorder” triggers drug classification; psilocybin marketed as a traditional preparation without therapeutic claims should qualify as a dietary supplement subject to adult-use restrictions.

Under the Dietary Supplement Health and Education Act, products can lawfully make “structure-function claims” — describing how a nutrient affects the body — without triggering drug status. We accept this for St. John’s Wort (“supports emotional balance”) and Kava (“promotes relaxation”). Neither is an FDA-approved drug, yet both are available with safety warnings but without prescriptions. 

Psilocybin fits naturally here. A product labeled to “support existential insight” or “enhance creative cognition” would align with the structure/function framework, validating the user’s intent (exploration) rather than pathologizing it (disease).

Dietary supplements – regulated under food law, not drug law – focus on Current Good Manufacturing Practices (CGMPs) and post-market surveillance. This suits substances where risks are contextual (set, setting, dose) rather than cumulative. Regulating psilocybin as food would shift emphasis toward reasonable standards: adulterant control, precise dosage transparency to prevent accidental overconsumption, and mandatory contraindication warnings (e.g., interactions with SSRIs).

Pluralistic Precedents

The Netherlands provides the clearest proof of concept. When the Dutch government banned psilocybin mushrooms in 2008, they omitted the sclerotia (the “truffle”), which contain the same psychoactive compounds. Truffles remain legal under the Dutch Commodities Act – the Dutch equivalent of food safety law. They are sold in “smartshops” subject to standard food safety regulations, including expiration dates and age certification (18+). This is an adult-use consumer product model: the state ensures the product is unadulterated and restricts sales to adults, but leaves the decision to consume it to the citizen.

Domestically, Oregon’s Psilocybin Services Act offers a parallel. While psilocybin remains Schedule I federally, Oregon state law regulates it as an agricultural commodity. The statute defines psilocybin-producing fungi as a “crop” and prevents the Health Authority from requiring a medical diagnosis for access.

Through early 2025, approximately 15,000 clients received services in Oregon with only minimal adverse events reported; data indicate a safety rate exceeding 99 percent. 

Public Health Concerns 

Objections to non-medical access typically center on acute psychological distress, misuse by vulnerable populations, and “commercialization.” These concerns are legitimate, but the pharmaceutical model is not the only way to address them. Food and supplement regulations often provide more direct tools for harm mitigation.

While drug regulation focuses on who can access a substance (the prescription), food regulation focuses on how the substance is presented (the product). A robust supplement framework would address fears through: 

• Mandatory Warning Labels: Explicitly flagging risks for those with a family history of psychosis. 
• Serving Size Limits: Capping potency per package to prevent accidental overconsumption. 
• Adverse Event Reporting: Creating a centralized database to track side effects — a standard supplement requirement that creates quicker feedback loops than the black market.

Food regulation offers a middle path, one that neither bans these substances nor transforms them into prescription-only commodities. Regulatory imagination requires recognizing the choice is not simply prohibition or medicalization, but a spectrum of governance tools.