Drugmaker: Take cautious approach to CBD regulation – Fence Post

Mark Bolton, senior director of U.S. public policy at GW Pharmaceuticals, discusses the regulatory framework for products made with cannabidiol, or CBD, a chemical found in hemp.
Photo by Jerry Hagstrom/The Hagstrom Report

ALBUQUERQUE, N.M. – State governments should take a cautious approach to regulating products containing Cannabidiol (CBD), an active ingredient in cannabis derived from the hemp plant, said an official from the pharmaceutical company that developed Epidolex, the only cannibis-based drug that has won approval from the Food and Drug Administration for disease treatment.

In 2018, FDA approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients 2 years and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana.

“It is important that regulators take a deliberative science-based approach,” said Mark Bolton, senior director of U.S. public policy and senior counsel for GW Pharmaceuticals.

Bolton said that state policies should encourage development of FDA-approved cannabis-derived medicines for serious and life-threatening diseases but that consumers need strong quality control over products to be sold in a mass-market setting without physician oversight.

Bolton added that he is certain FDA will take this approach. “There is a lot of therapeutic value left to be explored,” Bolton said.

While federal law says that hemp only contains less than 0.3 % tetrahydrocannabinol (THC), the psychoactive component also contained in marijuana, Bolton said that consumption of products derived from hemp can lead to consumption of higher amounts of THC. He added that products containing CBD can degrade over time.

Because the 2018 farm bill decriminalized hemp but said that the states have to develop hemp policies and license growers, the states will have an important role in regulation.

Farmers have showed great enthusiasm for planting hemp this year, even though there are concerns about the size of the market for the products.

Most states are trying to help farmers grow the crop and market it, but South Dakota Republican Gov. Kristi Noem vetoed a hemp cultivation bill and has said the legalization of hemp is a step toward the legalization of marijuana.

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