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FDA-Turned-CBD Chemist: Dosage Likely First Step of Federal Regulations

A lab tech closes CBD capsules after they are filled.EXPAND
A lab tech closes CBD capsules after they are filled.
Jacqueline Collins

Cannabis research and the industrial hemp trade have moved beyond basements and off-the-grid greenhouses and toward chemistry degrees and public shareholders. You can now buy CBD cream at Walgreens and CVS, or even add it to your meal at several restaurants in Denver.

One of Colorado's largest hemp producers, Veritas Farms, is plucking professionals from the same government departments that regulate cannabinoids, recently hiring former Food and Drug Administration chemist Dr. Daniel Connors to help lead the company's research and development work. A graduate of the University of Denver, Connors left school before legal marijuana or hemp were on the chemistry community's radar, but now finds himself using his knowledge and FDA experience to help advance cannabinoid wellness and therapy. We recently caught up with Connors to learn more about the future of hemp science and the FDA's upcoming rules regarding the plant.

Westword: While studying at DU, were hemp and CBD even lightly broached while you were in school?

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Daniel Connors: My Ph.D. was in analytical chemistry, and my original interests were in looking at contaminants in water. One of the big discoveries that inspired my graduate work was the discovery of antibiotics coming through wastewater treatment and showing up in rivers and streams. Hemp and CBD were completely off my radar at the time, and even when I worked for the FDA, the medicinal use of hemp products was pretty much overshadowed by problems with counterfeit drugs masquerading as nutritional supplements. My introduction to the CBD industry was largely through colleagues who were in the business of selling analytical instruments and tools to hemp and cannabis laboratories, and I discovered that many of the techniques I specialized in translated into skills the industry needed. I definitely did not predict that there would be an advanced scientific community in Colorado that specialized in the extraction of cannabinoids from hemp and cannabis when I was in school! (I also spent several years in the oil and gas industry — another thing I didn’t expect from a graduate degree focused on environmental analytical chemistry).

Do you see a need for universities and higher-learning institutions to tackle cannabinoid research more? In what areas of studies could this be done?

Hemp and cannabis research seems to be about fifty years behind other compounds from plants that have made the leap from use in alternative and complementary medicine to one recognized by the broad medical community. This means there is enormous breadth of research that should be explored, from basic questions about plant genetics and gene expression to direct clinical work that uses the human endocannabinoid system as a regulator of mood, pain relief, or many other potential effects. The endocannabinoid system is so poorly understood compared to other better-known neurological receptors that respond to opioids that it seems like a great deal of basic research is needed to understand the potential that chemicals like CBD or THC have. My work with Veritas Farms is trying to explore how some less common cannabinoids and terpenes could amplify endocannabinoid system responses to make effects like pain relief more predictable and reliable for consumers.

Besides the clear opportunities I see for medical developments, I think hemp offers a lot of opportunities for discovery in chemistry, biology and neurology. Unfortunately, I think federal restrictions and general unease from universities on cannabis research will limit some of these basic science questions from being answered in the U.S. in the near term, but I see a great deal of exciting work coming out of Europe and Canada, where research dollars for cannabis are a little more available.

Is there any pulse out there about how long the FDA will take with CBD regulations?

My current best guess is that a very limited set of regulations will be developed for the over-the-counter CBD market, and the FDA is likely to focus on safe dosage as an initial rule. This is a tough number to come up with, as there are thousands of academic journal articles that have been released in the last few years trying to assign a dose of CBD, THC or hemp oil to alleviate a wide swath of medical complaints.

Once the FDA defines what a safe dosage is for CBD, the next stage I would expect is a lot of work on product adulteration, label claims that can’t be backed up, and accuracy in the dose provided to the consumer. This will likely not be a major rulemaking cycle, but it could result in the FDA doing a lot of investigations and inspections, which could result in warning letters to individual manufacturers. An FDA warning Letter is a pretty severe outcome, and one we plan on avoiding by carefully monitoring FDA guidelines.

How do you see FDA regulations changing the CBD industry landscape? Will there be a weeding-out process as more rules come into effect?

I am certain that as the industry falls under more regulatory guidance, we will see a pretty aggressive selection for companies that are producing quality products and can back up their claims with sound science. Like any regulated industry, it will probably take a lot more resources to get products to the consumer market than the current situation, and I would expect we will see smaller consumer product companies fold into larger ones. The advantage of this for the consumer is confidence in the product. When the consumer buys a product that is covered by FDA regulations, they can have a lot more confidence that if it says it has CBD, it will, and if it says it is full spectrum hemp oil, it is.

What kind of cannabinoid/cannabinoid application methods are you excited to learn more about or utilize more?

I think there are some really exciting areas of research on how the whole body has endocannabinoid receptors, and these receptors may be able to alleviate symptoms for problems no one associates with the medical or recreational use of cannabis. Endocannabinoid receptors in the gut are potential targets for treatments for diseases like Crohn’s and irritable bowel syndrome. In the CBD industry, we have very basic methods of delivering our phytocannabinoids: ingestion and topical application. I am excited to work on new ways to package phytocannabinoids chemically, so that we can work on other parts of the body and potentially have impacts beyond its current uses.

How does hemp's environmental footprint compare to indoor marijuana grows? Do CBD-rich hemp plants require similar attention and resources?

We continue to adopt best practices every day in this industry, but because the product is worth much less per pound than recreational cannabis, the agricultural activity tends to have to rely on things like natural light and good soil. At Veritas Farms, we grow all of our hemp organically in the outdoors, and I think that organic farming has been a popular choice among hemp farmers in Colorado. We are also using drip irrigation, integrative pest management, and composting as methods of carbon footprint reduction. One aspect of environmental policy I hope to explore with Veritas in the future is regenerative agriculture. This is a series of farming practices that attempts to favor extraction of carbon from the atmosphere and capture in soil, with the sale of a cash crop (hemp oil) to support the environmental outcome. With larger-scale hemp farms, regenerative agricultural practices have a great opportunity to collect greenhouse gases rather than emitting them.

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