FloraWorks Pairs TruCBN Toxicology Data with Internal GRAS Assessment

Researchers at Product Safety Labs and FloraWorks have published a toxicology study in Toxicology Reports evaluating the oral safety of TruCBN, a high-purity cannabinol (CBN) isolate manufactured by FloraWorks. The study describes a multi-phase oral toxicity program in rats that supports a no-observed-adverse-effect level (NOAEL) and a calculated margin of safety for the ingredient, which is intended as a sleep aid.¹

As explained in the study, CBN forms as an oxidative breakdown product of cannabidiol (CBD) and tetrahydrocannabinol (THC) rather than being produced directly by the cannabis plant. TruCBN is manufactured via a patented process that converts hemp-derived CBD into cannabinol while rendering the material substantially free of THC.

"Our patented chemistry gives FloraWorks a uniquely defensible foundation to invest for the long term in developing the molecule," explained Alleh Lindquist, CEO of FloraWorks.² "Rather than simply supplying CBN into an emerging market, we're building the scientific, safety, and regulatory foundation for its broader use in human health, beginning with sleep and extending into healthcare and future therapeutic applications."

What Did Researchers Test and Find?

A maximum tolerated dose assessment found that a single 3,500 mg/kg dose, and repeated dosing at 1,750 mg/kg/day and above, exceeded rats' tolerable range. This informed a 14-day range-finding study and a definitive 90-day oral gavage toxicity study at 100, 200, and 400 mg/kg/day. “There were no clinical signs, body weight, food consumption, functional observations, or motor activity effects, and no clinical pathology, macroscopic, or microscopic changes attributable to the administration of the test substance,” the researchers noted. “The 90-day toxicity study supports a NOAEL for TruCBN™ of 400 mg/kg/day.”

Comparing this figure to an estimated human clinical dose of 0.833 mg/kg/day (based on a 50 mg daily dose and a 60 kg body weight), the study reports a margin of safety of approximately 480-fold, which exceeds the 200-fold threshold commonly applied by European food safety regulators when compound-specific data are available.

Is There Additional Research on TruCBN and Sleep?

TruCBN's safety data builds on earlier clinical work examining its effects on sleep. In a trial conducted by Radicle Science involving 1,020 participants, a 50 mg nightly dose of TruCBN produced a statistically significant improvement in sleep quality compared with placebo, as measured by the PROMIS Sleep Disturbance 8a survey, while 25 mg and 100 mg doses appeared less effective, suggesting a U-shaped dose-response relationship.³

What About TruCBN's GRAS Status?

Alongside the toxicology publication, FloraWorks announced that it has completed an internal Generally Recognized as Safe (GRAS) assessment of TruCBN for its intended conditions of use, incorporating TruCBN-specific manufacturing, compositional, and toxicology data with broader scientific literature on CBN. The company said the internal assessment is now under review by an independent panel of qualified scientific experts.

How Does This Fit Into the Current Regulatory Picture?

The publication comes as federal hemp policy remains in flux. A new statutory hemp definition, set to take effect under the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026, would cap total THC at 0.4 mg per container beginning November 12, 2026 (or December 11, 2026, pending a continuing resolution).⁴ Industry sources estimate that this threshold could affect roughly 95% of current hemp products.

Lindquist has said the cap is not expected to materially affect the company's supply chain, and noted that the newly published toxicology data are intended to support the company's pending New Dietary Ingredient Notification with the FDA.

References

1. Bauter MR, Hartung V, Dunn C, Jensen RP, et al. Investigation into the oral toxicity profile of TruCBN™. Toxicol Rep. 2026;17:102296. doi: 10.1016/j.toxrep.2026.102296
2. FloraWorks Holdings Inc. FloraWorks advances patented TruCBN platform with peer-reviewed safety publication and internal GRAS conclusion. Newsfile Corp. August 18, 2026. Accessed August 18, 2026. https://www.newsfilecorp.com/release/310171/FloraWorks-Advances-Patented-TruCBNTM-Platform-with-PeerReviewed-Safety-Publication-and-Internal-GRAS-Conclusion
3. Krawiec S. FloraWorks announced results of study demonstrating sleep benefits of its flagship CBN ingredient. Nutritional Outlook. August 23, 2023. Accessed August 18, 2026. https://www.nutritionaloutlook.com/view/floraworks-announced-results-of-study-demonstrating-sleep-benefits-of-its-flagship-cbn-ingredient
4. McEvoy E. How Washington's next move could reshape the cannabinoid supplement industry. Nutritional Outlook. August 13, 2026. Accessed August 18, 2026. https://www.nutritionaloutlook.com/view/how-washington-could-reshape-cannabinoid-supplement-industry