As medicinal cannabis products crowd shelves, Harold Smith is calling for quality control with his startup CannaMetrix. Smith believes inserting accurate labeling, with information on potency levels, into the buyer’s journey will keep the patient in focus.
“People stand (in a store) in absolute confusion and amazement, not knowing what to pick or why to pick it. They pick something that doesn’t work and they either never come back or they choose something else,” says Smith, founder and CEO of CannaMetrix. “What the industry fails to appreciate is that customer loyalty to products and choice cannot be determined based on current labeling.”
CannaMetrix hopes to provide medically relevant, biological endpoint metrics for validating the quality and potency of cannabis products and ensuring batch-to-batch consistency. This data would be available on a label, helping buyers of medicinal cannabis make informed decisions.
The company has developed a commercial assay that quantifies and predicts biological potency of cannabinoids in products. Its EC50 array tests dose-dependent activity through the human cell endocannabinoid system. CannaMetrix’s main customers are growers, producers of cannabis products and those in agro-genetic engineering seeking to develop new strains of cannabis, Smith says.
“Our goal is to differentiate products on the shelf based on our trademark for advanced potency testing so that consumers will have informed choice,” he says. “CannaMetrix’s test helps indicate which blends of cannabinoids, and at what potency, can modulate the human endocannabinoid system.
Chemical composition alone doesn’t provide enough insight into potency, says Smith, professor emeritus at the University of Rochester.
“Cannabinoids that don’t have a psychotropic effect do not have an indication of potency that occurs promptly. So, you just really don’t know how potent they are,” he says. “They don’t have a tell.”
With the legalization of marijuana, consumers have become familiar with two terms—CBD (cannabidiol) and THC (tetrahydrocannabinol). In the body, these cannabinoids bind to specific receptors on cells. However, Smith says, a lot hinges on the potency of each cannabinoid. Sometimes, cannabinoids at very low concentrations can be more potent than cannabinoids at higher concentrations.
Then, there’s the body’s response to it.
“These cannabinoids come into our body and they push away our own cannabinoids that we make,” Smith says. “So, the other thing that people don’t understand is that the reason why we can respond to the plant in the first place is we have a system in place that responds to cells, our cells, making a (few) cannabinoids, different than the plant, but sharing common structure.”
When plant cannabinoids enter the system, they cause cells in different organs to behave a certain way. The sum of those responses throughout the tissues in the human body is called the entourage effect.
“The plant cannabinoids interact together, sometimes synergistically, sometimes antagonistically, but it’s the soup, the flavor of the soup, that makes the difference in the perceived potency in somebody,” Smith says. “When they come in the body, they create this ambience of interactions, pushing things up, pushing things down. Whatever it is, the net is the consequence and is the potency that you experience.”
CannaMetrix’s proprietary test enables cannabis growers and developers to differentiate their products. Medically relevant, biological endpoints have not yet been adopted as metrics for validating the quality and potency of cannabis products and ensuring batch-to-batch consistency, the company claims.
Labeling, at its simplest, requires content of the product (amount per serving), associated health risks, and an impairment disclaimer. A 2022 study of the requirements for cannabis product labeling found that “a comprehensive framework for cannabis use is needed to protect the public, maximize benefits, and minimize harms and risks.
“Standardization of cannabis product labeling requirements would benefit consumers and promote safer and more effective usage of cannabis products,” the study states.
Like other medical drugs are tested for safety, dosage, effectiveness and toxicity, Smith believes that cannabis products, if tested and labeled with potency levels, would help consumers. CannaMetrix last year was granted a patent that says that chemical testing is insufficient for determining potency. Potency needs to be tested in the laboratory, Smith asserts, with a human endocannabinoid system.
Smith would know—a biochemist and biophysicist, he is a thought leader in the realms of gene editing enzymes, cardiovascular disease, antiviral host defense factors and HIV/AIDS. His extensive experience with biomedical research has helped his entrepreneurial streak with CannaMetrix and Oyagen. A preclinical drug discovery and development company, OyaGen focuses on identification of therapeutic indications for infectious diseases and cancer. That company raised $11.3 million in capital.
Even so, the cannabis industry is a tougher nut to crack. CannaMetrix has raised $2 million in investment, and Smith has invested $500,000 himself. CannaMetrix’s technology is disruptive—nobody has proposed testing products for biological potency the way it does, Smith says.
“It takes the focus off of compliance testing and going into a new standard that has the patient at the center of the question,” Smith says. “When you ask for actual biological potency (and biological toxicity), when you’re saying that you’re going to test those, you’re actually saying I’m anticipating this going into a human being. And I’m anticipating that they’re taking it for a reason.”
While states, including New York, have focused on the economic benefits, Smith questions why patients and their safety aren’t being considered with as much interest. In May, the U.S. Department of Justice submitted a proposed regulation to move marijuana from Schedule I (drugs with no accepted medicinal use) to Schedule III drug (a substance with low to moderate potential of dependance) like Tylenol with codeine, for example.
“Scientific data drive the products forward in the marketplace. There have to be packaging inserts, which there are none; there has to be true potency testing, which there isn’t,” Smith says.
While producers do have some potency claims—a rudimentary online search flags chromatography as an often used technique—a biologically relevant target is missing.
“A three-legged stool: What’s the chemical purity? What’s its activity on a biologically relevant target? And what is its toxicity? All drugs, Tylenol, you name it, all drugs come to market based on that,” Smith says. “What happened to cannabis?”
For now, CannaMetrix would like to reach cannabis producers across the nation to have their products tested, endorsed and trademarked. Business intelligence firm Statista predicts the global market for medical cannabis products will top $20 billion this year. The states that have legalized marijuana represent the largest market worldwide.
CannaMetrix, which employs five people including consultants, is in talks with four customers.
Smith would like CannaMetrix to find a strategic partner and clients to grow the business. Housed at 1200 Jefferson Road, CannaMetrix is a Drug Enforcement Agency and Bureau of Narcotics Enforcement-certified schedule laboratory.
“The scientific goals are that we understand that the cannabinoid system is not A binds to B (and) goes to C, it’s more like every alphabet, and every language is active at the same time, and how to sort through that and find the best methods to determine the potency on all those disease-relevant areas, which is what Schedule III is about,” he says. “So that we can go to the industry and say, against this method, develop the most potent product. We want to advance cannabis into the next generation of medicines through sophisticated human-based biological testing.”
He goes a step further to envision CannaMetrix adopting a personalized approach.
“Say you came to my lab, I have a physician’s assistant draw your blood, purify your white blood cells,” he says. “With a genetic trick I put in our reporter system that turns green in increasing doses with potency. I measure 180 different products that are out there that you have access to. And I tell you which of those is the most potent for your body. You choose the product that is most potent for you.”
Smriti Jacob is Rochester Beacon managing editor. The Beacon welcomes comments and letters from readers who adhere to our comment policy including use of their full, real name. Submissions to the Letters page should be sent to [email protected].
Kudos to Professor Smith for filling a need in the industry. Making it easier for people to understand the different effects different strains of CBD and THC produce in your body.