The company said it has strong data to support R&D and formulation efforts that focus on the development of non-psychotropic cognitive wellness products.
“The mainstream markets don’t touch cannabinoids,” said Alleh Lindquist, cofounder and CEO at FloraWorks. “You don’t see major retailers selling them and you don’t see major supplement brands selling them. It’s because they either don’t have this [NDI] status or because CBD is considered a drug… we’re hoping to really position this as a dietary ingredient that improves sleep quality.”
FloraWorks started selling CBN in 2020 and was the first company to bring it to market, Lindquist told NutraIngredients last year. CBN, like cannabidiol (CBD), is a natural chemical found in the cannabis plant. When parts of the THC in the plant age and break down, this creates the less potent cannabinoid CBN.
In a study published in 2024, TruCBN outperformed a standard dose of melatonin to promote better sleep, without significant side effects.
Cognitive health
In July, researchers from the Salk Institute published findings in Redox Biology that found that TruCBN reversed age-related cognitive decline in mice, producing measurable improvements in learning, memory, mitochondrial function and synaptic health—particularly in older female models—with no safety concerns at “practical” doses, according to FloraWorks.
“A major implication is that CBN might have distinct benefits for male and female subjects and so the sex of the consumer should be taken into consideration when suggesting how CBN might provide benefits,” said Dr. Pamela Maher, PhD, research professor at the Salk Institute and co-author on the paper.
Dr. Maher screens for compounds that could slow or stop the progression of neurodegenerative diseases.
Lindquist said that FloraWorks is looking to position TruCBN in the brain health category, helping to promote longevity and protect against aging.
“We’d like to make the case it can improve mitochondrial function, so we’re working on those structure-function dietary claims,” he added. “The dietary status filing is going to basically open up this clientele base that doesn’t normally touch these products today. They’ll have a new effective ingredient, and they’ll be able to sell it through channels that have traditionally been closed off. In our minds, it brings cannabinoids into a mainstream consumer market where they become more accepted, there’s more trust, there’s more credibility for it, which just hasn’t historically been there.”
NDI process
Many companies will only establish GRAS (Generally Recognized as Safe) status for their ingredients and enter the dietary supplement market through the fastest and most simple pathway possible, Lindquist said, noting that GRAS was not the appropriate avenue for TruCBN and that it was important to pursue a more difficult path by working with the FDA
“It’s the one that will bring the most credibility into this ingredient as large supplement companies bring it to market,” he added.
FloraWorks is currently preparing its studies for peer review and is drafting a presentation in preparation for an NDI pre-meeting with the FDA. There, the agency provides feedback on the likelihood it will approve a cannabinoid for a dietary ingredient, which Lindquist said will be the first time in the history of the FDA has considered a cannabinoid as a dietary supplement.
