Why Dietary Supplements Are the First Pathway for Cannabis Medicine
The cannabis industry has spent years waiting for this moment. As federal rescheduling moves forward, so do the opportunities to develop cannabinoid-based supplements and medicines backed by more rigorous scientific research.
For some companies, this isn’t a new direction. It’s the payoff from years of work happening behind the scenes.
Alleh Lindquist, CEO and co-founder of FloraWorks, has spent the past several years focused on building the scientific and regulatory foundation for CBN. As a leading supplier of hemp-derived cannabinoids, FloraWorks helped introduce CBN to manufacturers and consumers as a sleep ingredient. But that was only the first step. The company’s goal has always been to position CBN as one of the first cannabinoids to reach the market as an FDA-recognized dietary supplement.
After four years of toxicology studies and safety testing, FloraWorks recently published peer-reviewed research supporting CBN’s safety and self-affirmed the ingredient as Generally Recognized As Safe (GRAS). The company plans to submit its GRAS notification to the FDA, a milestone that could help establish a regulatory pathway for future cannabinoid ingredients.
I spoke with Lindquist about what it takes to navigate the FDA process, why scientific validation matters, and how the order of FDA approvals will shape the future of cannabinoid supplements and medicines.
In the next six months, the company expects to file a new dietary ingredient notification with the FDA, a key milestone in its regulatory strategy, even though it is still uncertain how the FDA will respond.
“We don’t know how they’ll respond to it,” Lindquist said. “It’s never been accepted before.”
Attempts to position CBD as a dietary supplement have repeatedly run into what regulators call “drug preclusion,” a rule that prevents an ingredient from being marketed as a supplement if it has already been approved as a drug.
Because Epidiolex was approved first, CBD products have struggled to gain acceptance as dietary supplements, even when companies have pursued GRAS determinations or FDA notifications.
“That’s the issue with CBD,” he said. “Once it became a drug first, it effectively blocked the supplement pathway.”
Why the Regulatory Sequence Matters
The first major cannabinoid to reach the pharmaceutical market was CBD through Epidiolex. While that represented a landmark achievement for cannabis medicine, it also complicated CBD’s future as a dietary supplement.
Under FDA rules, once an ingredient has been approved as a prescription drug, it generally cannot also be marketed as a dietary supplement unless it was already sold as a supplement before clinical drug investigations began. This “drug preclusion” provision effectively closed the door on CBD as a new dietary ingredient after Epidiolex was approved, despite growing public interest and research sparked by stories like Charlotte Figi’s response to CBD for severe epilepsy.
And for this reason, FloraWorks began with the dietary supplement pathway rather than drug development.
Why Focus on One Cannabinoid Instead of the Entourage Effect?
While much of the cannabis industry has embraced the entourage effect, Lindquist believes the next generation of cannabinoid science will focus less on combining cannabinoids and more on understanding what each one does individually.
His view is that cannabinoids have distinct biological mechanisms and shouldn’t be automatically grouped together. In fact, combining cannabinoids can sometimes diminish the desired effect. He pointed to research showing that 20 mg of isolated CBN improved sleep, but adding CBD reduced that benefit. Rather than enhancing one another, certain cannabinoids may override or interfere with specific biological activities.
FloraWorks chose to study one cannabinoid at a time rather than developing broad-spectrum formulations, focusing on understanding exactly what CBN does before combining it with other cannabinoids, with the goal of positioning CBN alongside melatonin on the shelf.
Beyond its potential role in sleep, Lindquist sees promising research suggesting CBN has unique neuroprotective properties related to oxidative stress and mitochondrial dysfunction. Working with researchers at the Salk Institute, the company evaluated dozens of cannabinoid structures and found CBN consistently outperformed other cannabinoids in protecting neurons from a form of cell death associated with neurodegenerative disease.
Cannabinoids and Healthcare Cost Savings
Lindquist also discussed cannabinoids in the context of healthcare costs, not just treatment outcomes.
He pointed to emerging federal programs, including CMS-led initiatives, that are exploring access to cannabinoids for older adults to improve health outcomes and reduce system-wide costs.
What happens to healthcare spending if sleep improves, pain is better managed, or certain prescriptions are reduced?
“If we have a sleep aid and we’re able to improve sleep for a cohort of people, how much downstream cost does that save?” Lindquist said.
He pointed to common risks associated with sedating medications like Ambien, including grogginess, falls, and related injury costs.
The next step is building the data to support those questions.
“There just isn’t enough data yet to make direct claims,” he said. “But we know what an insomnia patient costs in Medicare, and we know what a non-insomnia patient costs.”
FloraWorks continues to pursue pharmaceutical pathways, but the immediate priority is establishing CBN as a dietary supplement, where it can exist without prescription barriers.
“Because drug preclusion only goes one way,” he said. “If you go drug first, you can’t go back. But if you start as a dietary supplement, you can move forward into drug development later.”
The post Why Dietary Supplements Are the First Pathway for Cannabis Medicine appeared first on Cannabis Industry Journal.