“Magic mushrooms” are mushrooms that contain hallucinogens – usually psilocybin and psilocin. Taking magic mushrooms may cause you to see, hear or feel things that are not there, or to experience anxiety, fear, nausea and muscle twitches accompanied by increased heart rate and blood pressure. In some cases, the consumption of magic mushrooms can lead to “bad trips” or “flashbacks”.
The production, sale and possession of magic mushrooms are illegal in Canada.
There is increasing interest in the potential therapeutic uses of magic mushrooms and of psilocybin, one of the active ingredients in magic mushrooms. While clinical trials with psilocybin have shown promising results, at this time, there are no approved therapeutic products containing psilocybin in Canada or elsewhere. Clinical trials are the most appropriate and effective way to advance research with unapproved drugs such as psilocybin while protecting the health and safety of patients.
Magic mushrooms have been used for thousands of years. There are over 200 species of magic mushrooms. Since many species look alike, it can be hard to tell the different species of mushrooms apart. It is possible for people to consume poisonous mushrooms, mistaking them for magic mushrooms.
The active ingredients in magic mushrooms are chemicals called psilocybin and psilocin. As psychoactive substances, psilocybin and psilocin are controlled internationally under the United Nations Drug Control Conventions and, in Canada, under the Controlled Drugs and Substances Act (CDSA). Under the CDSA, activities with magic mushrooms, psilocybin and psilocin, such as sale, possession, and production, are illegal unless authorized by Health Canada (for example, through the issuance of a licence or exemption, or under the regulations). Like all drugs, magic mushrooms, psilocybin and psilocin are also subject to the Food and Drugs Act (FDA). Psilocybin and psilocin are hallucinogens that produce effects similar to LSD. Individuals using magic mushrooms experience hallucinations and an altered state of consciousness. Effects appear within 15-45 minutes and usually last for four to six hours.
When consumed, the effects of magic mushrooms can vary from person to person. In addition, the strength of magic mushrooms can vary greatly. One mushroom may have different concentrations of the active ingredients compared to another and, consequently, the effects of the magic mushroom can depend on the dose and type of mushroom used.
Magic mushrooms sold illegally may be in the form of dried whole mushrooms or a powder. People may choose to take the mushrooms in many ways, including:
Magic mushrooms should never be injected intravenously. There have been case reports in the literature of serious harms associated with intravenous injection of mushrooms, including septic shock and multi-system organ failure.
Psilocybin and psilocin are also produced and sold illegally as a powder or in tablets or capsules. Drugs produced illegally are not tested and may contain other dangerous substances.
Using magic mushrooms can lead to short-term mental and physical effects.
Magic mushrooms may cause heightened emotions and senses and people may feel happy and creative. They may laugh or giggle a lot and experience a sense of mental and emotional clarity.
Magic mushrooms can also cause hallucinations and affect people by:
Some of the negative mental effects of taking magic mushrooms include:
Taking magic mushrooms can produce:
Currently, no studies have evaluated the long-term effects of repetitive use of magic mushrooms.
There is little evidence that people can become physically or psychologically dependent on magic mushrooms.
However, it is possible to become tolerant to the drug’s effects with regular use. This may occur over several days of continued use. In this state, even high amounts of the drug will no longer produce the desired effect.
At this time, there are no approved therapeutic products containing psilocybin in Canada or elsewhere. This means that the safety, efficacy and quality of products containing psilocybin have not been assessed by Health Canada, and they have not undergone the rigorous scientific review process required to be authorized for sale in Canada or elsewhere. There is ongoing research looking at the potential of psilocybin to treat various mental health disorders such as anxiety, depression, obsessive-compulsive disorder and problematic substance use. While some initial clinical trials have shown promising results, the evidence is currently limited. Clinical trials are the most appropriate and effective way to advance research with unapproved drugs such as psilocybin while protecting the health and safety of patients.
Health Canada encourages Canadians seeking support for these disorders to talk with their health care provider about options available to them.
Health Canada recognizes there are times when access to unauthorized drugs may be appropriate. Patients suffering from mental health disorders should discuss potential treatment options with their health care provider. In some circumstances, with the support of a regulated health care practitioner, it may be possible for individuals to legally access psilocybin through one of three pathways:
Clinical trials and Health Canada’s Special Access Program are existing regulatory options through which a legal source of psilocybin may be accessed. These pathways should generally be pursued instead of an individual exemption under the CDSA, unless it can be demonstrated that access to psilocybin is not possible or suitable through these existing legal routes. Both clinical trials and the Special Access Program have safeguards and requirements in place to protect the health and safety of patients, help ensure the quality of the drug, and provide for administration and oversight by a qualified professional.
The Special Access Program and individual exemptions from the CDSA are not mechanisms to encourage the early use of unauthorized drugs, nor are they meant to be used as a means of circumventing clinical development or the established drug review and approval process.
Conducting clinical research is a critical step in the generation of good quality evidence needed to better understand the health benefits and harms associated with the potential therapeutic use of psilocybin. Clinical trials are the most appropriate and effective way to advance research with psilocybin while protecting the health and safety of patients and should be the first legal route pursued by individuals seeking access for therapeutic treatment.
Clinical trials protect patients by providing a framework so that a potential treatment is administered in accordance with national and international ethical, medical and scientific standards. They also must be approved by a research ethics board, which provides additional oversight to ensure that patients’ health and safety are protected.
Drugs used in clinical trials must meet Good Manufacturing Practices, the manufacturing standard used in the pharmaceutical industry, to ensure that patients are administered known quantities of quality-controlled active ingredients. This ensures that trial results are representative and reproducible. Clinical trials also benefit society because they help build the evidence related to the safety and efficacy of treatment options for patients.
Health Canada’s Clinical Trials Database lists all clinical trials in patients that have been authorized in Canada, including clinical trials involving psilocybin. Individuals wanting to participate in a clinical trial should talk to their health care provider.
Anyone who may wish to conduct a clinical trial in Canada is encouraged to read the Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications for more information on how to apply for a clinical trial authorization.
More information about clinical research with psilocybin can be found in the Notice to Stakeholders – Clarification of Requirements under the Food and Drug Regulations and the Controlled Drugs and Substances Act When Conducting Clinical Research with Psilocybin, which provides details on requirements, information on enforcement and compliance and links to related resources.
Once a clinical trial is authorized under Part C, Division 5 of the Food and Drug Regulations, authorization under Part J of the Food and Drug Regulations is required to permit the sale of the restricted drug psilocybin for clinical testing under the CDSA. Companies or organizations that are interested in conducting activities with controlled substances such as psilocybin or magic mushrooms must also have a licence, authorization or exemption from Health Canada.
For inquiries about clinical trials, individuals can contact the Office of Clinical Trials by email: oct.enquiries-requetes.bec@hc-sc.gc.ca.
Health Canada’s Special Access Program permits health care practitioners to request access to drugs that have shown promise in clinical trials or been approved in other countries, but that have not yet been authorized for sale in Canada. This program provides access to non-marketed drugs for the treatment of serious or life-threatening conditions when conventional therapies have failed, are unsuitable or are unavailable.
For emergency treatment purposes, when clinical trials are not available or suitable, it may be possible to access psilocybin through Health Canada’s Special Access Program. The ability for health care practitioners to request access to restricted drugs such as psilocybin through the Special Access Program was restored in January 2022 through regulatory amendments to the Food and Drug Regulations. Given that the Special Access Program is a well-established regulatory pathway that provides certain safeguards, such as access to a quality-controlled source of psilocybin and practitioner oversight, this pathway should be explored before making a request for an individual subsection 56(1) exemption under the CDSA. Practitioners are also responsible for reporting adverse drug reactions and whether the drug helped the patient or not.
Requests through the Special Access Program must provide sufficient evidence to support the use of the drug for the patient’s condition. Manufacturers who provide drugs through the Special Access Program are requested to confirm that their product is manufactured according to Good Manufacturing Practices, to ensure that patients are administered known quantities of quality-controlled active ingredients.
As with all Special Access Program requests, individuals cannot apply directly to request access to restricted and/or unauthorized drugs. Only regulated health care practitioners who are authorized to treat patients with prescription drugs may file requests on behalf of their patients through the Special Access Program. Note that practitioners requesting psilocybin under the Special Access Program must also meet the practitioner requirements under the CDSA.
There is no guarantee that a request for psilocybin, or any other unauthorized drug, will be granted through the Special Access Program. All requests are assessed on a case-by-case basis taking into consideration the level of evidence regarding the safety, efficacy and proposed use of the drug, the patient’s condition and clinical status, as well as any other information that may be needed to determine whether to issue the Special Access Program letter of authorization.
Practitioners considering the Special Access Program as a potential option can consult the Guidance Document for Industry and Practitioners for more information on how to make an application.
Should a request for psilocybin be authorized through the Special Access Program, the manufacturer will be issued a Letter of Authorization, which permits them to legally sell the specified quantity of the drug to the requesting practitioner. If the manufacturer is located in Canada, they must be a licensed dealer under the CDSA and psilocybin must be listed on their licence. If the drug is coming from outside of Canada, the product must be imported by a licensed dealer who has psilocybin listed on their licence and has obtained an import permit from Health Canada. Practitioners are responsible for identifying a manufacturer that can supply psilocybin. For assistance in this matter, please contact the Special Access Program directly.
Once a Special Access Program Letter of Authorization for psilocybin is issued, a Subsection 56(1) Class Exemption allows certain parties (e.g., practitioners, pharmacists practicing at a hospital) to legally conduct activities (e.g., sale, possession, transport, etc.) with psilocybin in relation to the Special Access Program authorization.
Practitioners inquiring about access to drugs through the Special Access Program are encouraged to consider information and forms available on the Health Canada website. The Special Access Program is also available to answer questions by telephone: 613-941-2108 (8:30-16:30 EST), by fax: 613-941-3194, or by email: sapd-pasm@hc-sc.gc.ca.
Subsection 56(1) of the CDSA is a discretionary power that allows the Minister of Health to exempt persons or a class of persons, controlled substances or precursors from the application of any provisions of the CDSA or its regulations for a scientific or medical purpose, or for a purpose that is otherwise in the public interest.
Each request for an exemption under subsection 56(1) is carefully considered on a case-by-case basis, taking into account the public health and public safety objectives of the CDSA and all relevant information.
Many factors are considered when reviewing and making a decision on a request for a subsection 56(1) exemption to use psilocybin in relation to a medical condition. These factors may include but are not limited to:
Psilocybin exemption requests in relation to a medical condition should include a letter of support from a medical practitioner. This letter of support should demonstrate that they have pursued other available legal routes to access psilocybin or demonstrate that these routes are not available or suitable to them, and provide diagnosis, prognosis of patient’s medical illness, clinical evidence of psilocybin use (if applicable) and details of their recommended treatment regime.
Individuals may contact the Office of Controlled Substances (exemption@hc-sc.gc.ca) for more information or submit a request for an exemption from the CDSA.
