Experts Seek Regulation to Forestall ‘Wild West’ of CBD Usage

WASHINGTON (CN) – Racing to catch up to an already booming industry for CBD products, the Food and Drug Administration met with experts Friday to determine whether the compound celebrated by its users as a miracle salve should face tighter regulation.

Muscle Joint & Relief Cream is displayed at the Cannabis World Congress & Business Exposition trade show, Thursday, May 30, 2019 in New York. The non-prescription cream is marketed by Green Roads of Deerfield Beach, Fla. (AP Photo/Mark Lennihan)

Short for cannabidiol, CBD is naturally occurring, nonpsychoactive ingredient in marijuana and hemp, distinct from the marijuana plant’s other well-known compound – THC, or tetrahydrocannabidnol.

Even before President Donald Trump signed off this past December on a farm bill that legalized hemp, availability of CBD had exploded throughout the United States in recent years.

With users hailing the compound as an inexpensive alternative to traditional pharmaceuticals, they can find CBD as an additive in a wide range of products including dog food, lotions, candy and vitamins.

But acting FDA Commissioner Ned Sharpless noted Friday that there are still many unknowns about CBD safety. Speaking this morning in the FDA’s first-ever hearing on CBD, Sharpless pointed to the lack of research about how the compound interacts with prescription drugs, as well as CBD’s increasing usage as a treatment for children’s epilepsy.

Sharpless emphasized that CBD represents “new terrain” for regulators because the compound is derived from marijuana, which is not yet legal across all 50 states, and that current FDA rules bar the addition of CBD to food or other consumer products.

With analysts at Cowen Research predicting that the industry for CBD could be worth up to $20 billion by 2025, more than 100 representatives for trade groups, patient-advocacy organizations and marijuana retailers came to the FDA’s offices in Maryland for Friday’s hearing.

Among those who called on the agency to tighten its CBD regulation was Kevin Chapman, a neurologist with the American Epilepsy Society.

“The current patchwork of regulations has led to an array of products with potential impurities like pesticides,” Chapman said. “By classifying CBD as a drug, we can regulate the compound and evaluate the content and purity.”

Noting that traditional epilepsy treatments can cost up to $30,000 a year, Chapman said that the $100-a-month cost of CBD has boosted its popularity despite fuzzy details about its usage.

“I have concerns about the unknown side effects on children’s developing brains and the long-term effects on adults regularly consuming it,” he said.

A cookies and cream flavored protein bar marketed by JustCBD is displayed at the Cannabis World Congress & Business Exposition trade show, Thursday, May 30, 2019 in New York. (AP Photo/Mark Lennihan)

Patients with Alzheimer’s represent another emerging market for CBD, but Keith Fargo, director of scientific outreach at the Alzheimer’s Association, told regulators at the meeting Friday that the research is “inconclusive and contradictory” — creating potential pitfalls for a desperate population.

Among retailers to address the FDA on Friday was Crystal Guess of NuLeaf Naturals, who urging the agency to hone in on accredited studies and research on CBD dosing.

“Everybody is different and there’s no magical chart that we can point to that says, ‘a woman with this condition at this age can take this much this many times,’” Guess said. “We need labeling, we need education, and we need the ability to hold companies and individuals who make false promises responsible.”

Guess pointed to the example of CBD retailers that advertise their product as “full spectrum.” This is meant to suggest that the CBD could contain trace amounts of THC, but Guess said the product may not be full spectrum at all. 

Joseph Reardon, assistant commissioner of the North Carolina Department of Agriculture, crunched the numbers at Friday’s hearing.

“There are 1,000 [hemp] growers in North Carolina,” he said. “There are 12,000 acres growing now with 4 million square feet in greenhouses alone. There are 601 registered farmers. And there’s at least $100 million in this crop. We know CBD is being sold across the nation.”

If states are left to carve out their own regulations without FDA guidance, Reardon said consumers could face a “Wild West”-like frontier that puts their safety at risk.

For now, the FDA has approved only one CBD-based drug: Epidolex to treat to forms of severe epilepsy known as Dravet syndrome and Lennox-Gastaut syndrome.

The FDA will take public comments on CBD regulation through July 2.

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