FDA Holds First Public Hearing on CBD

As the popularity of CBD (or cannabidiol) soars, the FDA held its first public hearing on the chemical that claims to help with a variety of ailments including pain and anxiety. 

At the FDA public hearing regulators were looking to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds; specifically about dosage, interactions, and why CBD should be put in food, drink, dietary supplements, and other products.

“While more than 100 people testified, I don’t think anyone provided sufficient scientific data to convince regulators that today there is a compelling need for CBD to be in food or drink, nor was there compelling scientific data to alleviate public safety concerns raised by government scientists who suggest there are potential risks of interaction with medications,” according to David Chadwick, founder and CEO of Leading Edge Pharms, Inc., a biotechnology company developing novel cannabinoid therapies and delivery systems,

The hearing ended without a consensus on how the FDA would move forward and it is likely that Friday’s meeting was the first step in what could be a lengthy regulatory process, according to Chadwick. “Even if the FDA decided to pursue the regulatory process, it will include potentially numerous rounds of public comment, a lengthy evaluation of data and many rounds of drafting language for proposed rulemaking, which could take years,” he says. “Bottom line, it does not look as though the FDA will be providing guidelines or approval for use of CBD in food, dietary supplement, or any other ingested consumer products anytime soon.”

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For now, the FDA needs to figure out the next step in working with the cannabis/CBD industry. Amy Abernethy, MD, PhD, deputy commissioner and acting CIO at the FDA, said in a tweet that the agency has a tough job in evaluating the compound, but it will work as quickly as possible to define a way forward.

“What that actually means is unclear,” Chadwick says. “For the immediate future, I see increased research and a developing spirit of ‘coopetition’ among industry stakeholders to address the FDA’s concerns in order to move the regulatory process forward. CBD proponents and the FDA both agree that there is a great necessity for a national uniform regulatory framework that protects public health. This is a great start.”

Chadwick offers healthcare executives three things to know about CBD:

• Choose experienced regulatory counsel who are engaged in the FDA rulemaking process.

• There are no shortcuts. “The opportunity for a successful partnership is greatest with those companies willing and able to put in the hard work to develop foundational science behind truly innovative products containing CBD,” he says.

• For industry participants, choose experienced partners carefully. “Alignment of strategic priorities is key to advancing company objectives in the current ambiguous regulatory environment,” Chadwick says. “Ensure that promoting health is a priority of your partners as well.”