Mushrooms traditionally used to reduce the effects of stress on the body. Adaptogenic mushrooms are not hallucinogenic and do not act on the mind or perception.
Federal legislation providing that the use, possession, and transportation of peyote by Native Americans for bona fide traditional ceremonial purposes is lawful and cannot be prohibited by states or the federal government, though it permitted the U.S. Drug Enforcement Administration to retain authority to provide “reasonable regulation and registration” to persons that cultivate, harvest, and distribute peyote.
A plant psychedelic traditionally used by indigenous peoples in South America for ceremonial and spiritual purposes. The primary psychoactive component of ayahuasca is DMT (N,N-Dimethyltryptamine).
A designation made by the U.S. Food and Drug Administration that expedites the review process for new drug therapies for serious medical conditions after initial clinical evidence is submitted to the FDA and shows that the new drug therapy may demonstrate substantial improvement over other available therapies.
U.S. Food and Drug Administration trials involving research participants, conducted in phases after drug discovery and preclinical studies, where researchers test the safety of a drug, look for side effects, calibrate dosage, and determine drug efficacy. cf. drug discovery, preclinical trials.
The common name for the U.S. Food and Drug Administration’s “Expanded Access” program which serves as a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational new drug product, including psychedelic drug products.
Federal legislation signed by U.S. President Richard Nixon in 1970. The CSA segregates a host of drugs into five schedules. Many psychedelic substances are listed on Schedule I, and are consequently deemed the most strictly controlled.
Categories of controlled substances under the Controlled Substances Act, ranging from Schedule I to Schedule V. Schedule I is the most restricted and includes many psychedelics.
Federal legislation that regulates the import and export of substances on Controlled Substances Act schedules and is implemented by the United State's Drug Enforcement Administration in conjunction with other federal agencies.
An international treaty which provides comprehensive measures against trafficking of psychedelic and other drugs, money laundering and the diversion of precursor chemicals.
An international treaty which requires signatory countries to harmonize their internal laws for controlling many psychoactive (including psychedelic) substances.
A process or status by which a criminal law or penalties imposed for violating a criminal law are reduced, reclassified, removed or disregarded, or by which law enforcement is directed to re-prioritize the enforcement of such laws. It generally does not completely remove the criminal status of a prohibited act.
Orally ingested products that contain dietary ingredients, including vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet, which are regulated by the U.S. Food and Drug Administration pursuant to the Food, Drug and Cosmetic Act.).
N,N-Dimethyltryptamine. A psychedelic chemical found in certain plants, such as ayahuasca, and which is listed on Schedule I of the Controlled Substances Act.
The first of three major steps in U.S. Food and Drug Administration drug research, where researchers look for chemicals that could have positive effects on the human body. Cf. Preclinical studies, clinical trials
A U.S. federal agency housed within the U.S. Department of Justice and established in 1973 during Nixon administration. The DEA enforces the Controlled Substances Act.
The U.S. Drug Enforcement Administration requires certain persons, entities, and organizations to register with the agency in order to manufacture, import, distribute, store, prescribe, and/or administer certain drugs on the Controlled Substances Act schedules.
3,4-methylenedioxy-methamphetamine. A synthetic drug that was added to the Controlled Substances Act on Schedule I by the U.S. Drug Enforcement Administration regulatory action in 1985.
A 1990 U.S. Supreme Court case which upheld the State of Oregon’s denial of unemployment benefits to a person fired for consuming peyote in violation of state law, even though it was consumed for religious purposes. The case spurred the 1993 passage of the Religious Freedom Restoration Act.
Synthetic and organic substances that are psychoactive and cause psychedelic effects for spiritual or religious purposes.
A synthetic substance first synthesized in the 1960s similar to ketamine and is used for depression (in Spravato) and as an anesthetic (in Ketanest).
Federal legislation passed in 1986 to supplement the Controlled Substances Act by deeming any chemical intended for human consumption that is “substantially similar” to a Schedule I or Schedule II controlled substance as being on the applicable schedule.
An Amendment to the U.S. Constitution which states in relevant part that “Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof . . . .” Religious freedoms protected by the First Amendment have been the basis for U.S. judicial decisions and laws concerning psychedelic substances in certain contexts.
A U.S. federal agency within the U.S. Department of Health and Human Services (DHHS) responsible with regulating the safety of foods, drugs, medical devices, cosmetics, and tobacco products, pursuant to the Food, Drug and Cosmetic Act.
U.S. federal legislation passed in 1938 that charged the Food and Drug Administration with regulating the safety of foods, drugs, medical devices, cosmetics, and due to recent amendments, tobacco products.
Non-psychoactive mushrooms, such as chaga, cordyceps, lion’s mane, reishi, shiitake, turkey tail, that have other health benefits, and are often marketed as foods or dietary supplements.
2006 case decided by the U.S. Supreme Court, in which the Court held that under the Religious Freedom Restoration Act, the government would need to show a “compelling interest” for prohibiting the importation and use of a psychedelic controlled substance.
Psychoactive substances that cause hallucinations.
A federal law that prohibits tax deductions or credits on a trade or business relating to the trafficking of substances on Schedule I or Schedule II of the Controlled Substances Act. Judicial decisions have allowed deductions only for the cost of goods sold, or deductions tied to a “separate trade or business.”
A plant psychedelic traditionally used by indigenous peoples in Africa for medicinal, ceremonial, and spiritual purposes, and listed on Schedule I of the Controlled Substances Act.
A referent to the medical condition for which a drug is used. The U. S. Food and Drug Administration approves drugs for specific indications, though physicians often prescribe or administer drugs for other indications.
A 2019 voter approved initiative in Denver, Colorado constituting the first local U.S. measure to decriminalize the possession and use of mushrooms containing psilocybin.
An FDA program that allows pharmaceutical companies to obtain permission to start human clinical trials and obtain an exemption to federal law to be able to ship the drug across state lines.
A synthetic substance with anesthetic and some psychedelic effects first synthesized in the 1960s. It was approved as an anesthetic by the U.S. Food and Drug Administration (in Ketalar, an intravenous drug). Ketamine was listed on Schedule III of the Controlled Substances Act in 1999.
A plant species (Mitragyna speciosa) native to Southeast Asia that has psychoactive, though not psychedelic properties. Advocates claim that it can be used to treat opiate addiction and other conditions. It is not presently on a Controlled Substances Act schedule but the U.S. Food and Drug Administration has undertaken regulatory actions against importers and sellers of kratom, and some states prohibit it.
The process by which criminal laws are removed such that the act or thing previously criminalized is no longer criminalized and, generally, becomes regulated by federal, state, and/or local government agencies.
Lysergic Acid Diethylamide, a synthetic psychedelic substance synthesized by Albert Hofmann in 1938 in Switzerland. It is included on Schedule I of the Controlled Substances Act.
Psilocybin Mushroom Services Program Initiative (2020). An approved ballot measure in the State of Oregon that legalized (and will regulate) the manufacture, delivery, and administration of psilocybin by licensed persons upon the promulgation of regulations by the Oregon Health Authority by or before 2023.
Drug Addiction Treatment and Recovery Act. An approved ballot measure in the State of Oregon that, inter alia, removes penalties for low-level drug possession, including of psychedelic drugs.
A psychedelic compound found within certain cacti plants such as San Pedro cactus and peyote. It is included on Schedule I of the Controlled Substances Act.
A process by which a small amount of a psychedelic substance is taken to avoid strong effects but to obtain associated benefits.
A prominent U.S. nonprofit research and educational organization founded in 1986 in direct opposition to the listing of MDMA as a federally controlled substance, and which develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana.
A process that allows drug sponsors to propose that the U.S. Food and Drug Administration review and approve a drug for certain indication(s).
A commitment toward shaping the work in the psychedelic filed around integrity, developed by 100 psychedelic industry stakeholders and adopted by many others.
The prescription or administration of a drug for an indication other than the indication approved by the U.S. Food and Drug Administration.
An advisory board in the State of Oregon tasked with making recommendation to the Oregon Health Authority for promulgating regulations for the state’s psilocybin regulatory program pursuant to Measure 109. The board is composed of scientific and legal experts, and its Licensing Subcommittee is chaired by Harris Bricken attorney Mason Marks.
Forms of intellectual property rights for inventions granted by the U. S. Patent and Trademark Office. Patents confer exclusive rights to make, use, and sell the underlying invention and offer protections of up to 20 years. Certain psychedelic substances may be eligible for patent protection.
A plant psychedelic native to the Americas that contains psychedelic compounds, primarily mescaline. It is included on Schedule I of the Controlled Substances Act.
A type of medicine that uses roots, stems, leaves, flowers or seeds of plants to improve health, prevent disease and treat illness, and commonly associated with psychoactive and psychedelic plants.
The second of three major steps in U.S. Food and Drug Administration drug research, where researchers test the research drug on cells in a laboratory or on animals. They do this to learn what the research drug may do in the human body. cf. drug discovery, clinical trials.
A three-year initiative at the Petrie-Flom Center of Harvard Law School to examine the ethical, legal and social implications of psychedelics research, commerce and therapeutics, under Senior Fellow and Project Lead Mason Marks of Harris Bricken.
A psychedelic substance that is found in many psychedelic mushrooms along with psilocybin. It is included on Schedule I of the Controlled Substances Act.
A psychedelic substance found in many psychedelic mushrooms along with psilocin. It is scheduled on Schedule I of the Controlled Substances Act, though a number of jurisdictions have decriminalized its possession and the State of Oregon has created the framework for a regulatory program for it.
An online media company providing in-depth psychedelics medicine sector analysis.
An exchange traded fund (“ETF”), notable as the first ETF aggregating U.S. listed psychedelics companies.
Events to which individuals travel to consume psychedelics, generally for medicinal, spiritual, and/or ceremonial purposes, and also generally under the supervision of religious leaders or trained professionals.
Drugs that cause sensory (audible and visual) or psychological hallucinatory effects.
www.psychedelicslawblog.com. A blog authored by Harris Bricken attorneys discussing the impact of psychedelics laws on industry stakeholders.
Rules created by government agencies pursuant to legislative authority, with the force and effect of law. In the U. S., regulations are promulgated through a process known as “notice and comment” where a state or federal agency publishes draft regulations and solicits comments from the public before finalizing the regulations.
U.S. Drug Enforcement Administration guidelines allow persons to petition for exemptions to the Controlled Substances Act for the religious use of psychedelics in accordance with the Religious Freedom Restoration Act of 1993 and the 2006 U.S. Supreme Court case Gonzales v. O Centro Espirita Beneficente Uniao do Vegetal. The agency’s process is opaque, and the agency never or almost never grants exemptions.
Federal legislation passed in response to the 1990 U.S. Supreme Court case, Employment Division, Department of Human Resources of Oregon v. Smith. RFRA’s goal was to restore prior tests used to evaluate laws of general application as applied to specific individual circumstances and to “provide a claim or defense to persons whose religious exercise is substantially burdened by government.”
Federal legislation passed in 2018 that allows patients diagnosed with a life-threatening disease who have tried all approved treatment options to access certain treatments unapproved by the U.S. Food and Drug Administration. Efforts have been undertaken to allow access to controlled psychedelic drugs pursuant to this legislation.
Salvia divinorum. A plant species with certain psychedelic properties. It is not included in any federal Controlled Substances Act schedule though it is prohibited in many states.
A California Senate bill introduced by California Senator Scott Wiener in 2021 that was intended to decriminalize a host of psychedelics and initiate the process for determining how to eventually legalize and regulate such substances.
An international treaty that prohibits the production and supply of certain drugs. The treaty required signatory nations to enact legislation to carry out its requirements. The Controlled Substances Act was enacted in the U.S. pursuant to the Single Convention.
Spore kits allow individuals to cultivate mushrooms. In many cases, they do not contain controlled substances but can be used to cultivate mushrooms containing controlled substances such as psilocybin. Their legal status is complicated, and several U.S. states have outlawed spore kits capable of producing controlled substances.
A nasal spray drug containing esketamine approved by the U.S. Food and Drugs Administration in 2019 for treatment-resistant depression.
An underlying substance or layer of organic media used in the cultivation of psilocybin mushrooms.
A term used in U.S. Food and Drug Administration drug trials, including for psychedelic drugs, in reference to any event not present prior to the initiation of treatments, or any event already present that worsens in either intensity or frequency following exposure to the treatments.
Federal agency charged with enforcement of United States federal law.