The Food and Drugs Act defines a drug broadly: any substance manufactured, sold or represented for use in diagnosing, treating, mitigating or preventing a disease or its symptoms, or in restoring, correcting or modifying organic functions (Justice Laws, Food and Drugs Act). Its regulations, the Food and Drug Regulations, set the rules for clinical trials, drug approvals and the Special Access Program.
Health Canada says that, like all drugs, magic mushrooms, psilocybin and psilocin are subject to the Food and Drugs Act, in addition to the Controlled Drugs and Substances Act (Health Canada, magic mushrooms). The two laws ask different questions: one whether a substance is controlled, the other whether a product is safe and authorized for sale.
Part J of the Food and Drug Regulations, made under this Act, governed restricted drugs such as psilocybin and LSD until the Controlled Substances Regulations replaced it on 1 October 2026 (Canada Gazette, SOR/2025-242). Bill C-286 would amend the Act. The consolidated text we read on Justice Laws was current to 30 September 2026. Not legal advice.
General information, not legal advice.
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