The Rotation: Vol. 32
How Edible Extracts Circumvent Potency Limits, Health Canada Issues Guidance for Clinical Trials on Psychedelics, and Historical Cannabis Research Bill Signed
Increasing Number of Companies Bypassing Potency Limits on Edibles
A number of cannabis producers in Canada are taking advantage of a “loophole” in the cannabis regulations by producing edibles that are not intended to be consumed “as food” by utilizing different naming conventions such as “lozenges” and “sublinguals”, writes StratCann.
The Breakdown
- Products like Organigram’s Jolts and Aurora’s Glitches, which are labelled as edible extracts and contain 10mg THC each with 10 lozenges in a package, for a total of 100mg THC.
- The primary way that edible extracts circumvent the potency limits is by not using sugar, a key ingredient in most edible products but is restricted from being used in cannabis extracts per the Cannabis Regulations.
- Sugar is being replaced with oligofructose, a dietary fiber that is not considered a sugar or sweetener in Canada.
Our Perspective
The 10mg THC limit on edibles has been a major issue, with lobbying groups like the Cannabis Council of Canada now making it one of their key mandates of cannabis regulatory reform. Unsurprisingly, these products are gaining a significant amount of popularity and translate as a value offering for consumers, providing higher potency products that provides better flavour compared to capsules at a reduced cost. However, concerns are being raised that if these products are ingested (specifically by children) without the proper labelling requirements and nutritional information, the industry as a whole could be negatively affected and come under heavy scrutiny.
Guidance Information from Health Canada Issued to Stakeholders in Psychedelic Industry
Health Canada has issued a notice to stakeholders in the psychedelics industry, physicians, therapists and others regarding that outlines requirements for future clinical trials involving psychedelic-assisted therapy, reports Mugglehead.
The Breakdown
- Health Canada’s notice outlined several risk-management measures required for all clinical trial applications (CTAs) including that all therapists involved with psychedelic-assisted psychotherapy have adequate training and certifications that is documented and stored appropriated and that sufficient therapy sessions occur before and after the administration of psychedelic drugs to build trust with the patient.
- When drugs are being administered, Health Canada advises that there should be at least two therapists present and a licensed physician overseeing the treatment, and potential participants must be adequately screened by a physician to ensure they meet the eligibility requirements.
- Health Canada also outlined recommendations regarding the environment where psychedelic drugs are being administered, as well as the requirement for informed consent forms to be given to participants prior to commencing treatment.
Our Perspective
Health Canada is clearly trying to take the necessary precautions due to the growing interest in psychedelic-assisted psychotherapy. Given the nature of this type of therapy, there is an inherent need to mitigate physical and psychological risks for participants involved in the studies and its encouraging to see Health Canada being proactive on this, particularly when there’s an increasing number of stories coming to light in recent years related to physician mal-practice and abuse.
Biden Signs Landmark Cannabis Research Bill
Biden has become the first American president to sign cannabis-specific reform legislation into law, reports MJBiz Daily.
The Breakdown
- The white house announced that the bipartisan Medical Marijuana and Cannabidiol Research Expansion Act has officially been signed by Biden.
- The landmark legislation, which is intended to make it easier for scientific researchers to study the plant, also calls on the federal government to examine the potential therapeutic benefits of cannabis.
- The bill also enables research universities as well as private companies to acquire U.S. Drug Enforcement Administration licenses to grow and handle cannabis for research purposes.
Our Perspective
Although the bill was expected to become law when initially announced, it’s still a ground-breaking moment for cannabis reform in the U.S. Most importantly, industry stakeholders are hopeful that the bill could have a direct and significant impact on the rescheduling process for cannabis that was recently requested by Biden to determine whether their stance on cannabis is consistent with current science and the law.