By Floraworks Distinguishes Supplier Compliance From Ingredient Qualification
Floraworks has spent the last several years evaluating cannabinol (CBN) as a mainstream food and dietary ingredient. The company says its biggest lesson was that being a compliant cannabinoid supplier and having a qualified ingredient are two very different standards.
The cannabinoid industry has historically focused heavily on manufacturing compliance, including GMPs, certificates of analysis, potency testing, contaminant testing, traceability, and state licensing. Floraworks says those systems are important and that it has invested significantly in them.
The company explains that manufacturing compliance answers the question of whether a batch passed its COA. Ingredient qualification instead asks what evidence supports the safety and identity of the ingredient for its intended use.
Floraworks says that when an ingredient is evaluated through established food and dietary supplement frameworks, manufacturing compliance is really just the starting point. The company has spent significant time evaluating CBN for both GRAS and the New Dietary Ingredient (NDI) pathway.
Floraworks says working through these frameworks requires a much more complete picture of an ingredient than the cannabinoid industry has historically had to develop.
What Floraworks Says Buyers Should Ask CBN Suppliers
Floraworks recommends separating basic supplier qualification from ingredient qualification. Buyers should verify the quality-management system, GMP status, traceability, analytical testing, specifications, and manufacturing controls.
The company says a commercial ingredient is more than the name of its principal constituent. How it is manufactured, its purity, its specifications, its impurity profile, and its consistency all matter when connecting scientific evidence to the material consumers will actually receive.
Floraworks says suppliers should be asked to define the ingredient precisely, including how it is manufactured, what controls exist around potential impurities and degradation products, and whether stability data supports the specification.
The company notes there are multiple ways to produce and purify cannabinoids. If toxicology is conducted on one material, clinical research on another, and the commercial ingredient has materially different specifications, it becomes much harder to understand what the evidence actually supports.
Floraworks says its current GRAS evaluation is built around specifically defined intended uses and exposure conditions. A safety conclusion developed around one set of conditions should not automatically be extrapolated to every other possible use.
Safety Program Findings And Next Steps
Floraworks says its safety program includes GLP toxicology work and genotoxicity evaluation. The company’s 90-day repeated-dose oral toxicology study established a no-observed-adverse-effect level (NOAEL) of 400 mg/kg body weight per day in an oral exposure model.
The company says a NOAEL has to be interpreted in the context of the study design, the test material, intended human exposure, the broader peer-reviewed scientific literature, and other available safety information. It advises against viewing a single number as the safety story.
Floraworks says working through a formal safety assessment demonstrates what the evidence supports, where it is limited, and where additional testing may be warranted. The customer-focused question shaping its research program is what additional research needs to be performed to better inform the consumer.
