INSIDER Law
Marijuana Extract Rule Stifles Hemp Industry

Experts Discuss CBD Benefits, FDA Warning Letters at Colorado Hemp Expo

The April 1 session at the NoCo Hemp Expo brought to light the gray legal area in which CBD producers are operating.

Janel Ralph, whose company produces CBD hemp oil, has a daughter named Harmony who was born with a rare genetic condition that causes intractable epilepsy.

Speaking earlier this month during the NoCo Hemp Expo in Loveland, Colorado, Ralph noted her daughter’s consumption of the Palmetto Harmony CBD oils has resulted in “a 90-percent reduction in seizures, and we’ve been able to remove 80 percent of our pharmaceutical meds."

Harmony is in good company. Other families with children who suffer from epilepsy have described the purported wonders of CBD or cannabidiol, which derives from the hemp plant but unlike marijuana contains little of the psychoactive ingredient known as THC.

Cannabis expert Robert Clarke cautioned there needs to be more research to substantiate the anecdotal stories like the one told by Ralph.

“What I see going on at the moment is a big cart before the horse," said Clarke, the executive director of BioAgronomics Group, an international cannabis consulting firm, during an April 1 session on the state of the CBD market at the NoCo Hemp Expo. “I very much hear what you say about your child and I hear this all the time and obviously cannabis produces good medicines. But we need proof of this.

“So what I’m always going to call for is scientific backing for the anecdotal research that we have," continued Clarke, who co-authored the book “Cannabis: Evolution and Ethnobotany" and serves as project manager with the Netherlands-based International Hemp Association. “And until we can get this, it’s hard for me to consider cannabis a viable medicine … Remember, I’m a scientist and I don’t believe in fairytales. We need proof for what we already feel in our hearts."

The session brought to light the gray legal area in which CBD producers are operating. Referencing substantial clinical drug trials that are being conducted by GW Pharmaceuticals plc, FDA has opined that products containing CBD cannot be sold as a dietary supplement. The agency acknowledged an exception if CBD was marketed as a dietary supplement or conventional food before the new drug investigations were authorized, but FDA has determined the exception isn’t applicable to CBD.

David Bonvillain, founder of Colorado-based Elite Botanicals, an organic hemp farm providing CBD-based products, is among the critics who disagree with the agency’s conclusion.

“I know that there was folks in California making CBD products and selling those products long before GW got the patent for that granted by the FDA," Bonvillain said.

“I think there is an interesting level of scare tactic going on where they [FDA] are not exactly saying that you can’t do this," he continued. “They are saying that you have to prove that what we’re saying is wrong in order to continue to justify what you’re doing or you have to reclassify the product."

Bonvillain noted CBD products disappeared from Amazon’s website before a handful of them reemerged as “concentrated hemp oil."

“This starts getting into a weird nomenclature game with what do they say you can call it and what are we going to try and call it to be able to then get it out into the people’s hands," he said. “Ultimately, the consumer loses in those situations."

FDA also has warned a number of CBD marketers that they cannot make claims that the products treat medical conditions. Such claims render the products unapproved new drugs, the agency cautioned.

FDA’s message still may not have resonated with everyone.

“What can we do to … prevent Big Pharma … from coming in and taking it [CBD] and not preventing us from being able to … provide patients with medicine they need … the way we are doing it versus Big Pharma," a man in the audience asked the panel of hemp experts. “I feel like the research has been done. What can we do to … get the FDA off our back and kind of move forward?"

Clarke advised that people stop calling CBD medicine.

“That’s the way to get around Big Pharma," he said. “Stop going into their front room and pooping in it. Just leave them alone … and call it food, nutritional supplement, healthcare product."

“Leave the decision about medical use up to the user, to the mothers in this room," Clarke added. “They are the only ones that should decide what it is, not our government, not Big Pharma."

Hemp farmer Rick Trojan of Colorado Cultivars said, “We can make the decision about Big Pharma by what we purchase and we on the industry side can make decisions to create something and not call it a medicine. Call it a supplement or food additive or whatever we want to call it and then you as consumers have a choice.

“Do you take the Big Pharma option," Trojan asked, “or do you take the holistic option? That’s going to be up to everyone."  

A woman who said she was thinking of selling CBD oil asked the expert panel about the risks of selling CBD and whether FDA can shut down a marketer of manufacturer at any time.

“I think it’s very important to understand that some of these companies that had received letters were actually making claims of treating illness and their bottles were also grossly mislabeled," responded Ralph of South Carolina-based Palmetto Synergistic Research LLC. “I’m looking at it from a different perspective thinking that maybe the FDA is doing their job and maybe that they are sending letters to [disreputable] companies trying to get them to come up to the bar."

Ralph said her company calls her products hemp oil—not a dietary or nutritional supplement.

“We don’t make any claims to treat," said Ralph, who recommended a CBD website contain “very bland" information. “We don’t put testimonies on our website that can be construed as us saying something."

Acknowledged Josh Hendricks, a licensed hemp farmer in Kentucky and director of business development (domestic production) with CV Sciences, Inc., a producer and marketer of CBD: “It is certainly a gray area that we operate in and I think we’ve all had attorneys that help us operate in that."

 

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