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“While hemp-derived CBD extract is believed to have neuroprotective, anti-inflammatory, and anxiety-reducing benefits, the ‘how’ by which CBD works is still unclear,” says Pelin Thorogood, Radicle Science (San Diego, CA) cofounder and executive chairwoman. “Most evidence points towards a calming effect in the central nervous system or a reduction in the levels of pro-inflammatory cytokines in our immune system. Consumers and CBD brands alike are hungry for more rigorous scientific data to shed light on how these products can be used to help people live healthier, fuller lives.”
“[CRN doesn’t] oppose [S. 1698], but we think it takes on more than we need to take on right now,” explains Mister. “We’d like to see supplements move through quickly and then revisit this issue with food. As much as FDA doesn’t like the idea of having CBD in supplements, they seem to be very opposed to putting it in food. So, we say, why take that on? Let’s get supplements done and demonstrate that they can be sold safely; then we’ll come back and work on food.”
“I think it’s just bad faith on the part of the agency to put the companies through this, and it sends a terrible message to other companies that will disincentivize them to follow that route,” says Mister. “So, what you’re looking at then is a continuation of the current market where companies don’t file NDIs, the market is full of ingestible CBD products, and none of them have been evaluated by the agency.”
This avenue may therefore pose its own challenges, but the possibility of legitimacy is absolutely worth exploring. It’s unfortunate that one of the things that dogs the industry is the idea that it’s unregulated. Unfortunately, FDA’s own inaction when it comes to CBD only reinforces this idea, to the detriment of responsible industry and the benefit of fly-by-night brands. What’s clear, however, is that CBD is not going anywhere, and FDA seems to have resigned itself to that by doing the bare minimum, limiting its enforcement to warning letters, and waiting for Congress to create a regulatory pathway.
“Given the growing number of commercially available CBD formulations, there is a lot of confusion about how these products work, what they do for different people, not to mention the basics: when, what, and how much to take for any given condition,” explains Thorogood. “With that in mind, it is not surprising that the top two barriers preventing consumers from trying CBD are still a lack of research on its health benefits and an inability to gauge the effectiveness of specific products.”
While FDA might dismiss peer-reviewed toxicology studies on a case-by-case basis, such as it did with the recent NDI notifications, broader efforts are underway to demonstrate the safety of CBD.
All these efforts are crucial when securing the future of hemp-derived CBD. Even failed NDI notifications don’t need to be viewed negatively per se.