Marketers of hemp-based CBD (cannabidiol) have gotten creamed over the last several years, amid regulatory uncertainty, fierce competition and price wars.
The good news is that some human clinical studies whose results have been published in recent months show promising health effects for the broader cannabinoid category, including the CBD market.
Over the summer, Charlotte, North Carolina-based cbdMD Inc. announced the publication of its human clinical trial datademonstrating health benefits of its broad-spectrum CBD blend.
The 12-week study of 54 healthy males and females was completed by researchers at the University of South Carolina. Among the benefits noted, participants who consumed 100 mg (milligrams) of the broad-spectrum CBD blend for 90 days realized substantial pain relief compared to the group who took a placebo.
“The primary takeaway is everyone — males and females — had a significant reduction in pain,” said Sibyl Swift, Ph.D., chief science officer and VP of regulatory affairs with cbdMD, in an interview over the summer.
In other findings from the randomized, double-blind, placebo-controlled trial, men showed notable decreases in “anger-hostility” scores after consuming the product for 60 days, while females reported reduced perceived stress levels over the 90-day period of consumption, cbdMD reported.
The results showed the broad-spectrum CBD is well-tolerated and safe and are consistent with prior toxicity research that affirms the safety of consuming 2.29 mg per kilogram of body weight daily, according to the company.
“A lot of people fail to actually look at [toxicity] endpoints when they do clinical studies,” Swift told SupplySide Supplement Journal (previously known as Natural Products Insider). “They only focus on how the product was beneficial. They don’t look at serum markers over the course of the study to determine whether or not there was a toxicological effect in people.”
The clinical trial results were published online in June in the Journal of the International Society of Sports Nutrition.
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On July 31, Porland, Oregon-based FloraWorks announced peer-reviewed publication of its study on TruCBN, a proprietary version of cannabinol (CBN). The results of the double-blind, placebo-controlled study of over 1,000 participants were published in the journal Pharmaceuticals.
Among the key findings, 50 mg of TruCBN showed significantly improved sleep quality compared to placebo and outperformed a standard dose of melatonin. Study participants also observed no material differences in side effects compared to placebo.
In a July 31 press release, FloraWorks CEO Alleh Lindquist described publication of the clinical trial results as “a major step forward in our efforts to bring TruCBN into the mainstream markets as a safe and effective alternative in the fight against sleeplessness.”
In an interview in August with SupplySide Supplement Journal, Lindquist said he wants TruCBN to be incorporated in prominent supplement brands such as Kirkland Signature, Life Extension and Nature Made. He added his company has commenced talks with major retailers and brands.
In the dispensary market, where states regulate legal recreational cannabis, four of the five top-selling products are CBN SKUs, Lindquist said, referencing data from BDS Analytics (now known as BDSA) and Headset.
Unlike the regulatory challenges facing the CBD category, FDA has not determined that CBN cannot be marketed in supplements, and Lindquist said he wants CBN to be “sold alongside other dietary ingredients next to the melatonin on the sleep shelf.”
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The same day as FloraWorks’ announcement, MDbio – The Doctor’s Brand (MDbio) publicized the results of its clinical trials involving more than 3,500 Americans.
Los Angeles-based MDbio shared that:
– MDcalm significantly outperformed placebo for anxiety and sleep disturbance, resulting in clinically meaningful improvements in 77% and 66% of participants, respectively, in clinical trials involving 1,461 adults. The product combines full-spectrum hemp, magnesium and a botanical blend of adaptogens.
– MDsleep significantly outperformed placebo for sleep disturbance, anxiety and stress, resulting in clinically meaningful improvements in 57%, 60% and 38% of participants, respectively, in clinical trials involving 620 U.S. adults. The supplement also significantly outperformed placebo for improved quality of life. MDsleep contains full-spectrum hemp with GABA (Gamma-aminobutyric acid), L-theanine and bio-terpene complex (hops, valerian and proprietary terpene oil blend).
– The results of the MDsleep clinical trial were published in the peer-reviewed journal, Nutrientsand the company’s CEO, Brenden Dougherty, told SupplySide Supplement Journal in August that the clinical trial results for two other products — MDcalm and MDrelief — were being submitted for peer review.
– MDrelief significantly outperformed placebo for pain interference and pain intensity in women below age 50. Averaged across all genders and ages (21 to 77), clinically meaningful improvements were observed in pain interference and pain intensity in 54% and 66% of participants respectively, in clinical trials involving 1,160 U.S. adults. The supplement blends full-spectrum hemp with geranylgeraniol, frankincense and white willow bark.
“Women under 50 responded extremely well to MDrelief in our clinicals,” Dougherty said in an interview. “So now, running a clinical of women under 50 will give us better results and potential clinical standards in that subset.”
Jeff Chen, M.D., is co-founder and CEO of Radicle Science, which conducts clinical trials on natural products. Radicle Science spearheaded the clinical trials for FloraWorks and MDbio, which was founded by four Los Angeles physicians.
MDbio’s clinical trials were noteworthy, considering the state of science to substantiate the health benefits of dietary supplement products, according to Chen and Dougherty.
“Less than 1 percent of supplement SKUs available in America have clinical evidence that they are more effective than placebo,” Chen said in a recent interview.
Dougherty described being able to share the clinical results as an “incredibly powerful” marketing tool, especially within the health care practitioner channel, and he said his company’s labels will contain a “clinically proven” seal.
“Our sleep product is clinically proven to help you get better sleep,” he said. “It’s also clinically proven to decrease stress and decrease anxiety, and it’s clinically proven to give you a better quality of life. Those are claims we can make and substantiate based on our clinical results.”
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Making advertising and marketing claims based on clinical results is an art unto itself. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), marketers can make statements about the effects of an ingredient on the structure or function of the human body.
But the U.S. Food and Drug Administration may consider a statement an unlawful disease claim, even if a company has robust clinical evidence that a product or ingredient mitigates pain or anxiety, for example, and even if the Federal Trade Commission believes an advertisement is substantiated.
Complicating matters for the CBD category, FDA continues to assert the ingredient is excluded from the definition of a dietary supplement. Its position, based on a drug (Epidiolex) that was approved in 2018 to treat rare, severe forms of epilepsy, has not been challenged, upheld or rejected in the courts.
cbdMD’s Swift, a former official in FDA’s Office of Dietary Supplement Programs (ODSP), is aware of the federal rules and complexities surrounding the CBD category, including the potential pitfalls of touting the health benefits of a product based on clinical results.
“You have to make a business decision if you’re willing to take on the risk, and in the supplement space … we’re not going to make egregious statements about how [broad-spectrum CBD] impacts disease-level pain,” she said. “But does it impact post-workout? Absolutely.”
Radicle Science co-founder and executive chair Pelin Thorogood said there needs to be more studies on CBD and minor cannabinoids to explore how they interact with the endocannabinoid system and hopefully promote wellness across such conditions as anxiety, sleep and pain.
The “marijuana/cannabis/THC/cannabinoid universe” is facing a “trough of disillusionment,” according to Chen. But should cannabis become legalized in the coming years at the federal level, the physician anticipates a resurgence of interest and investments in the category, including in nonintoxicating cannabinoids.
In the meantime, Chen and Thorogood believe that research will continue to be led by ingredient suppliers like FloraWorks rather than finished-product brands in the cannabinoid space.
“Everything starts with ingredient suppliers,” Thorogood said.
This reality could help ingredient companies like FloraWorks build relationships with prominent supplement brands and differentiate the relatively few brands like cbdMD and MDbio that have demonstrated the health benefits of their finished products through clinical trials. According to a 2024 report published by McKinsey & Companywhich surveyed more than 5,000 consumers in China, the United Kingdom and U.S., efficacy and scientific credibility are two of the most important factors when choosing wellness products.
Consumers today are “hoping … the influencer at this brand is telling them the truth,” Dougherty of MDbio said. “But we’re changing that paradigm, so you don’t have to believe in hope. You believe in our data, and you believe in science.”
