August 27, 2023

Natural Medicine Regulation

In November of 2022, Coloradians voted to approve Proposition 122, known as the Natural Medicine Health Act, a citizen-initiated measure to decriminalize certain psychedelic substances and create a regulated facilitated use program. In May of 2023, Colorado Governor Jared Polis signed Senate Bill 23-290 (SB 23-290) into law, which effectively replaced Proposition 122 and formally implemented regulations governing the personal and facilitated use of psychedelics in Colorado. The following outlines the key components of the law and what individuals looking to operate in Colorado’s new psychedelics market need to know.

Adult Personal Use of Psychedelics

SB 23-290 removed all state and local criminal penalties for adults aged 21 years of age and older who grow, process, store, use, process, transport, obtain, share, or ingest psilocybin, psilocin, dimethyltryptamine (DMT), ibogaine, and mescaline (excluding peyote) for personal use (C.R.S. 18-18-434(5)(a)).

While these substances may be given away, it is not legal to receive remuneration in exchange for a psychedelic substance or give substances away as part of a business promotion or commercial activity. Moreover, paid advertising relating to the sharing of psychedelics or provision of services intended to be used concurrently with a person’s consumption of psychedelics is not allowed (See C.R.S. 18-18-434(5)(a)).

Although, remuneration may be provided for certain services, including for bona fide harm reduction services, bona fide therapy services, or other bona fide support services, and individuals may maintain personal or professional websites related to natural medicine services, disseminate educational materials related to natural medicine, or limit the ability of a healing center to donate natural medicine or provide natural medicine at reduced cost consistent with department rules (C.R.S. 18-18-434(12)(d)).

Regulated Facilitated Adult-Use

The Colorado Department of Regulatory Agencies (DORA) and Colorado Department of Revenue work together to create rules governing the manufacture, cultivation, testing, storage, transfer, transportation, delivery, sale, and purchase of natural medicines by and between healing centers and other permitted entities and the provision of natural medicine services to participants (who must be 21 years of age or older).

Until June 1, 2026, the definition of natural medicines for purposes of regulated facilitated use will include only psilocybin and psilocin. Thereafter the Department may add dimethyltryptamine (DMT), ibogaine, and mescaline (excluding peyote) to the list of legalized “natural medicines” if the Board so recommends.

A healing center is defined as an entity licensed by the Department that does any of the following: acquires, possesses, cultivates, manufactures, delivers, transfers, transports, supplies, sells, or dispenses natural medicine and related supplies; provides natural medicine for natural medicine services at locations permitted by the department; holds administration sessions; or where facilitators provide natural medicines services.

Natural medicine services refer to services provided by authorized facilitators to a participant before, during and after the participants consumption of natural medicine. Specifically, this includes a preparation session, an administration session, and an integration session.

As mandated by SB 23-290, Governor Polis appointed members to the Natural Medicine Health Board (the “Board”), whose task is to develop and submit policy recommendations to DORA. These members have diverse backgrounds and significant expertise spanning psychedelic therapy, health policy, religious and indigenous use of psychedelic medicines, behavioral health, and harm reduction.

Localities may regulate the time, place and manner of healing center operations within its boundaries, although localities do not have the authority to prohibit healing centers or licensed health-care facilities from providing natural medicine services.

Timeline for Implementing Regulations

By January 1, 2024: The Department must adopt rules to establish the qualifications, education and training requirements for facilitators and rules necessary to approve facilitator training programs.

By September 30, 2024: The Department must adopt rules necessary to implement the regulated natural medicine access program and begin accepting applications for licensure. All decisions regarding licensing applications must be made within 60 days of submission.

After June 1, 2026: The Board may implement rules to approve and regulate dimethyltryptamine (DMT), ibogaine, and mescaline (excluding peyote) for facilitated use. The Department may prepare proposed rules for the addition of any of these substances in anticipation of the Board’s recommendation to regulate.

Manzuri Law – Psychedelic Attorneys

Having blazed a trail in the cannabis space, the Manzuri Law team draws on experience from the earliest days of the cannabis industry to address and mitigate crossover issues in the emerging psychedelics industry. Sign-up for the Manzuri Law newsletter to stay up to date on new psychedelic policy or contact us to learn how you can prepare to operate as a facilitator, healing center, licensed health-care center, or harm reductionist.