This article was originally published by Ohio Valley ReSource.

The U.S. Food and Drug Administration sent out 15 letters last week warning some companies that sell cannabidiol, or CBD, about making unfounded medical claims regarding the effects of the hemp-derived compound. Many users claim CBD has a wide range of medicinal benefits but there is little evidence. Despite this warning, the burgeoning industry in the Ohio Valley continues to boom.

Daddy Burt Hemp Company in Lexington, Kentucky, was the only Ohio Valley business to receive a warning letter. The FDA said the company is making unfounded claims including that CBD could help with arthritis, schizophrenia and children with autism. 

Because of those claims, the company was therefore advertising their products as “unapproved new drugs” that violate FDA regulations. The only CBD-based drug approved by the FDA is Epidolex, used to treat rare, severe forms of epilepsy. Representatives with Daddy Burt Hemp Company did not respond to requests for comment. 

The FDA said in a statement that some of the available data “raise serious concerns about potential harm from CBD.” Those include potential liver injury, interactions with other drugs, drowsiness, diarrhea and changes in mood. 

The FDA warned that studies in animals have shown that CBD can interfere with the development and function of testes and sperm and “decrease testosterone levels and impair sexual behavior in males.” 

One regional industry leader called the FDA’s concerns regarding the safety of CBD “overblown.”

“They issued what we believe are so very overblown claims about what would happen if you would take enormous amounts of CBD,” said Jonathan Miller, former Kentucky state treasurer and general counsel for the U.S Hemp Roundtable, an industry group. “They mentioned liver disease, sterility…the types of things where there are indications in very, very large doses in animals. There’s certainly no human experience to that.”

Miller said CBD companies should not make medical claims about their products given continuing scientific uncertainty surrounding CBD’s effects. But Miller said the FDA is also dragging its feet on rules that would give clarity to businesses about how CBD can be sold. 

Hemp advocates, including Miller, want CBD to be regulated as a dietary supplement, which would allow the compound to be legally added to food products. Because CBD is currently an FDA-approved drug, it currently can’t be added to food products. Miller said he believes it will take Congressional action to allow for this change.

The hemp industry in the Ohio Valley continues to boom. The number of hemp acres farmers planted in Kentucky and West Virginia quadrupled in 2019 to more than 26,000 total, compared to the previous year. Kentucky is also held its first “hemp summit” Wednesday, December 4 in Louisville.

Sean Southard is a spokesperson for the Kentucky Department of Agriculture, which is hosting the summit. He said because of the economic potential of having CBD marketed as something like a dietary supplement, he hopes the FDA will regulate the cannabis compound so that it will benefit farmers. 

“I think generally, a lot of folks in the industry are anxious about what the FDA is going to do,” Southard said. “We understand the public health component, but we want to make sure we do our job in the Department of Agriculture in advocating for our farmers.”

Barry-Lee Tace, who helps run Cap City CBD Plus in Charleston, West Virginia, said he welcomes FDA regulation to provide clarity for his small business. He believes CBD has the potential for numerous medicinal benefits, but it may take time for clinical studies that would allow companies to make claims about their products.

“I think the problem with CBD is its such a wide spectrum of aspects that it does that I’ve experienced in my life,” Tace said. “It can be a part of the problem. It’s just a lot there.”

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This article was originally published by 100 Days in Appalachia, a nonprofit, collaborative newsroom telling the complex stories of the region that deserve to be heard. Sign up for their weekly newsletter here.