Restricted Growth
Therapeutic performance studies are nearly unheard of in the cannabinoid industry due to regulatory inaction on the federal level, making it nearly impossible to conduct these studies in the United States. Nearly 100 years after the “reefer madness” era, even non-psychotropic cannabinoids such as CBD still have major roadblocks in the way of being studied for efficacy.
Clinical Studies
Recent political developments however, including the house bill (HR-8454) passed on December 2nd, will allow for more efficacy testing on cannabinoid products. Kazmira is excited and hopeful for additional opportunities and resources in our pursuit of the truth about cannabinoid safety and efficacy. We are actively working with partners to conduct clinical studies that demonstrate the bioavailability of our products including Imperial Oil®, and Silver Plume®.
Schedule 3 Therapeutics
Beyond Epidiolex, which is an FDA approved CBD based drug for epilepsy, the therapeutic category has been at a standstill in the CBD industry. However, a recent HHS statement that was released at the end of August 2023 indicates that HHS recommends rescheduling of cannabis to Schedule 3. This new regulatory pathway is the key to opening up CBD and other cannabinoids to the therapeutic category, and Kazmira is already preparing for new opportunities in the space. Compared to the Cosmetic and Self Care categories, safety is even more important when it comes to a therapeutic product. In addition, conducting in-vitro and in-vivo clinical studies that prove ingredient efficacy will be essential for launching a successful cannabinoid based therapeutic product.
Food and Drug Administration (FDA) Disclaimer
These statements have not been evaluated by the FDA. These products are not intended to diagnose, treat, cure or prevent any disease.
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