Who Are The Companies Stepping Up To Prove The Safety And Efficacy Of Cannabis To The Government?

Scores of anecdotal feedback over the years could lead many to conclude that cannabis is safe and effective for recreational and many medical uses.

But, the lack of lab data halts any determination made by governments and departments such as the U.S. Food and Drug Administration (FDA).

Proving the safety and efficacy of the plant remains difficult. Factors such as federal prohibition, cannabis use and the plant's makeup all play a part. The nascent space is doing its part to provide the federal government and consumers with assurances as best it can.

Sources say the companies attempting to carve out their place in the market must provide proof to consumers through studies and protocols to verify the safety of cannabis and the brand producing them.

Barriers Prevent Cannabis From Proving Its Safety Or Efficacy To FDA: While most of the public may be convinced of cannabis, the FDA process has only approved four medications so far: The CBD-derived epilepsy medication Epidiolex; Marinol, a dronabinol-based synthetic cannabis-derived nausea medication; Syndros, a dronabinol-based liquid synthetic cannabinoid used for nausea and appetite loss; and Cesamet, a nabilone-based synthetic used to treat extreme nausea and vomiting. 

Dr. Jordan Tishler, CEO of inhaleMD and president of the Association of Cannabis Specialists, said the major obstacle in the way of wider-scale approval is that the plant's many chemicals appear to work together to produce its expected result. This effect is often described as the Entourage Effect.

Tishler explained that "it's hard to verify that the chemicals are the same in each batch, and in fact, we know that they are not."

Federal prohibition is another significant barrier. Julie Martellini, MCR Labs manager of scientific operations, said federal regulations must change for progress to occur.

"Until research is legally allowed and given time to catch up on how cannabis and its individual components affect people ... we will not be able to claim anything for sure," Martellini explained.

She added that the process would differ if the plant or its cannabinoids were regulated as a recreational substance like tobacco. "It would be a completely different matter," Martellini said.

In early February, a bipartisan U.S. Senate effort reintroduced legislation to promote cannabis research by streamlining the application process. The original Cannabidiol and Marihuana Research Expansion Act had passed unanimously in the Senate the previous year. A similar, separate bill passed in the U.S. House of Representatives in December 2020.

Companies Must Fill The Void, Demonstrate Safety: Without the needed lab studies, companies have to demonstrate their cannabis products are safe.

"In the absence of all-inclusive data, showing safety is the responsibility of companies ... to make sure that what they're selling is safe for human consumption," stated Hempfusion Wellness Inc. CBDHF CEO and co-founder Dr. Jason Mitchell. 

Mitchell, an executive board member of the U.S. Hemp Roundtable, said that investing in data is crucial for market development. He added that doing so helps the industry verify that cannabis is safe for consumption and performs as intended.

"They're actually laying the foundation for the future of this industry," said Mitchell of companies investing in research.

He noted that HempFusion spent the past 24 months collaborating with the company's raw material supplier to perform safety studies around maximum tolerated CBD doses, including a 14-day acute study and a 90-day long-term analysis.

Dr. Jeremy Riggle, chief scientist for BellRock Brands Inc DXBRF portfolio company Mary's Brands, said that companies can test cannabinoid content and accurate dosing measures.

"We test our cannabinoids both internally and externally all the time, so the materials can be tested and verified despite the FDA's position," stated Riggle.

Mitchell said the emphasis on safety is paramount. He highlighted the FDA's questioning of CBD's safety in 2019 as a sign of ongoing concerns in the government.

The company is in the process of submitting its NOEL ("No Observed adverse effect level") manuscript. It joins data HempFusion compiled while part of a 13-company analysis of CBD and liver toxicology beginning in September 2020.

Industry advocacy group Valid Care arranged the study. Mitchell said the research analyzed 1,475 people, with 839 completing the study, considering it the largest human observational liver toxicology study on CBD.

"We're putting a tangible, real connection to the safe use of CBD," Mitchell said of the studies.

In March, Mitchell joined the other companies in the study along with the FDA's cannabis product council to review the findings. 

(Photo by David Gabrić on Unsplash)