Now that the ‘green rush’ dust has settled, the fly-by-night gas station brands that once plagued the industry are being overshadowed by companies who are leading with science—and the savvy consumers have caught on.
“I feel like every other day sees new research confirming the anecdotal benefits of this compound in a scientific setting. From menopause to anxiety to sports recovery to pet wellbeing, science is looking deeper and reporting exciting results. In turn, consumers are more comfortable bringing CBD into their lives,” said Scott Mazza, COO and Co-Founder of Vitality CBD. “We are at a moment of great momentum.”
Following the June 2021 announcement of ingredient juggernaut DSM becoming the first major ingredient supplier to get into CBD, many others have followed suit. Earlier this year Kemin announced it was entering the CBD space. In September, it was announced that Wegmans Food Market will give shelf space to 5 SKUs from cbdMD. In October, Charlotte’s Web passed a significant milestone by becoming the first CBD brand to enter into a partnership with Major League Baseball, the first such sponsorship agreement for any CBD with a major sports league.
And just days ago, President Joe Biden made history when he signed the bipartisan Medical Marijuana and Cannabidiol Research Expansion Act. The landmark legislation is intended to make it easier for scientific researchers to study the plant.
CBD goes mainstream
The year has brought greater social acceptance, less taboo and more research for CBD said Mazza.
“A good example of changing social attitudes is in sports. In this sector, athletes are more regularly speaking about the benefits of CBD and athletic recovery. Moreover, research is backing it up. And now, just like any other product, CBD is allowed in certain advertising and sponsorship deals. It might seem small, but this kind of inclusion goes a long way to removing the stigma related to CBD,” said Mazza.
Sibyl Swift, PhD, Vice President, Scientific & Regulatory Affairs at cbdMD, Inc. said that NSF for Sport opening up to CBD products was a huge development for cbdMD.
“We led the way with the first product on the market that was certified for sport. This certification means that ANYONE that could stand to benefit from cannabinoids may take these products without the fear of failing a drug test. This allows government employees, nurses, doctors, emergency responders, military personnel and athletes to seek support for mood, sleep, inflammation, and general wellbeing through botanically-derived solutions. cbdMD was the first brand to achieve this notable certification. We are excited to see sports leagues beginning to accept cannabinoid-derived products. This will expand the general acceptance of cannabinoids as mainstream wellness solutions,” said Swift.
Swift added that cbdMD filed a Citizen’s Petition through the Natural Products Association (NPA), 1) asking the FDA to review our safety data through the established NDI process fairly, without bias against cannabinoids or novel ingredients and 2) providing supporting information as to why cbdMD believes the drug preclusion rule should not be applied to CBD.
For newcomers Cultivate Biologics, the company is said it is taking a very measured, science-first approach to bringing full spectrum cannabinoids to market–a stark contrast to the market's previous approach amid the hype around CBD and the passage of the 2018 Farm Bill.
“This year at Cultivate, we worked diligently at creating a detailed characterization of our oil, with the characterization done by multiple institutes, both domestic and international. We also launched several safety studies and pharmacokinetic studies, which will provide key data to drive our ingredients plans and the larger CBD-based market as a whole in 2023,” said Christian Kjaer, chairman and CEO, Cultivate Biologics.
Science for the win
“This year, CBD clinical studies were beginning to establish a link between CBD consumption and pain management, such as sleep, mood, anxiety, women’s health, personal care, and other health concerns. Several products have been designed to address women’s health issues, specifically, discomfort from PMS to cramps and migraines. All positives. Science started to come into play in a big way. Radicle Science and Open Book Extracts conducted the first ever clinical trial study comparing cannabinoids to melatonin, with most participants receiving a cannabinoid product experiencing significant improvement in sleep quality and duration as well as less of one of melatonin’s most common and cumbersome side effects: grogginess,” explained Sheldon Baker, CEO, Baker Dillon Group and Producer of the 420 Area Code.
“This is a big year for CBD and science. I feel like one of the biggest breakthroughs was a recent study into anxiety. The phase 2 clinical trial showed that CBD can help patients quickly achieve and maintain symptom reduction with few side effects. This is so important because more than half of CBD users turn to the compound to treat anxiety. But, qualitative studies have largely stayed quiet regarding its efficacy until now,” said Mazza. “Another big report indicates CBD has therapeutic potential to help women manage menopause. The study reported impacts on the immune system and the gut microbiota to improve energy metabolism and bone homeostasis.”
With the health implications of both studies being huge, Mazza said so too are the perception implications. “In my view, this is another big step for medicine to take CBD seriously. With time, the hype and novelty around the compound are dying out. We are left with more serious companies and serious products. This is a good thing for maturity.”
cbdMD completed clinical studies on the benefits of its broad spectrum hemp extract in both humans and dogs, providing data to support the benefits of cbdMD products on a number of key endpoints such as pain, mood, inflammation and immunity. Swift said cbdMD anticipates publishing the data from both studies prior to submitting structure function notifications for the aforementioned claims during the first half of 2023.
Regulatory hurdles
While the year has unleashed in some exciting advancements on the science front, one sticking point remains: FDA’s lack of movement.
Swift noted that while states have stepped up in the gap left by FDA’s inaction, a 50-state patchwork legislative solution is not tenable long term. “Maintaining compliance with 50 different state regulations is challenging, but has become a known cost to operate in the cannabinoid space. We are actively engaged with state agencies whenever possible to present reasonable legislative language and options to ensure that there is a clear regulatory path for efficacious and safe products for cbdMD’s customer’s wellbeing.”
“The regulatory environment continues to be a challenge. There has been no movement by the FDA nor Congress to clear the pathway for hemp extracts or cannabinoid isolates to be used legally as dietary supplements on a national level. A patchwork of regulations at the state level still exists, along with even more complexity internationally. The regulatory hurdle has resulted in many mainstream dietary supplement brands refraining from developing cannabinoid formulations,” said Stacey Evans, VP General Counsel, Cultivate Biologics.
“Unfortunately, regulators continued to drag their feet. Look no further than the ‘debate’ of CBD and dietary supplements. The Food and Drug Administration (FDA) was radio silent for three years on the topic before returning to it in late June. In the interim, some players are creating unregulated food products without official safeguards. We need action on this and FDA approval will go a long way to legitimizing the market,” said Mazza.
According to Swift, the deadline for FDA to respond to cbdMD’s Citizen’s Petition has passed without a substantive response from the Agency.
“In light of the recent reversal by the Agency due to a technicality regarding approval dates for another dietary ingredient, we believe that now is the time to stand up as an industry and ensure that the Agency does not block innovation in the dietary supplement space,” said Swift.
And the recent spate of warning letters sent by FDA to companies seeking to use CBD in foods and beverages was seen by the industry as a significant step back.
