Prior to Monday’s rule proposal, there was no need for pre-market approval or mandatory notification about the safety of a new chemical or ingredient through self-affirmed GRAS. Instead, companies like FloraWorks can employ an independent panel of experts to to support a self-affirmed GRAS conclusion. Under the proposed rule, food and beverage manufacturers would have to notify FDA when relying on a GRAS conclusion.
“We think [the proposed rule] is generally a good thing, though it will add to an already backed-up review queue,” said FloraWorks CEO Alleh Lindquist. “The timing for any new rules to take effect and the potential of what the final rules would say is too far away at this time. Comments run for 120 days, then the FDA has to work through them and draft a final rule. Any actual change is years away.”
The company is not discouraged by the FDA’s action and concluded the self-affirmed GRAS process for TruCBN, the company’s proprietary cannabinol isolate. It has limited conditions of use, as pregnant and lactating women and children are excluded from taking the substance.
Rather, FloraWorks’ efforts are now centered on its push to make TruCBN a new dietary ingredient, which the company said would be the first NDI for a cannabinol. By the end of 2026, the company will submit the new dietary ingredient notification (NDIN), which has cost $1.4 million to prepare. Filing both the NDI and carrying out self-affirmed GRAS is part of a larger “corporate strategy,” according to Lindquist.
Toxicology studies
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, it creates CBN, a less potent cannabinoid. FloraWorks started selling CBN in 2020 and was the first company to bring it to market.
The company went on to develop TruCBN as an ultra-pure, hemp-derived formulation of cannabinol. It is a non-intoxicating, THC-free substance that is positioned as a non-hormonal sleep aid.
In a 2024 study, TruCBN outperformed a standard dose of melatonin to promote better sleep without significant side effects. FloraWorks will soon publish a 2026 peer-reviewed toxicology study for TruCBN. The latest toxicology results along with additional peer-reviewed studies will be included in the new dietary ingredient submission.
According to FloraWorks, independent researchers tested TruCBN in a randomized, double-blind, placebo-controlled trial of 1,020 participants across five arms. At 100 mg per day, twice the company’s 50 mg dose, reported adverse events did not differ significantly from placebo. Reported side effects were mild or moderate, and no serious adverse events were identified.
Brain research
Earlier this year, Lindquist said that FloraWorks was seeking to position TruCBN in the brain health category, with a focus on longevity and healthy aging.
“There are some mechanisms that CBN exhibits uniquely over other cannabinoids,” Lindquist explained. “There is some new data that we’ve been able to put together that shows CBN basically fitting inside of a pocket in the membrane of mitochondria.”
Lindquist added that one of the core issues in longevity, NAD+ and the broader effort to boost mitochondrial energy production is inflammation and oxidative stress in the brain, which can contribute to mitochondrial dysfunction.
He said mitochondrial dysfunction can, in turn, contribute to neuronal damage and is implicated in a range of neurodegenerative diseases.
CBN may help reinforce the mitochondrial membrane against oxidative stress, Lindquist noted.
“So we look at maybe CBN as going to end up being an incredible longevity supplement,” he said. “It’s helping with sleep and potentially that functionality is part of the sleep effect. If you’ve got oxidative stress inflammation in your brain, that might lead to not sleeping.”
