Federal health regulators say the lack of scientific data about cannabidiol explains their delay issuing new guidance on over-the-counter CBD.
The U.S. Food and Drug Administration continues to accept comments on hemp- and cannabis-derived ingredients, months after the comment period closed, according to Sharon Lindan Mayl, senior policy adviser in the FDA’s Office of Food Policy and Response.
Mayl said this week that the FDA needs more data about CBD, despite the more than 4,500 comments it has received since it began its review of regulations for hemp-derived CBD.
A landmark public meeting about cannabis at FDA headquarters in May and the many online submissions didn’t yield enough scientific evidence in support of CBD, reported Informa Pharma Intelligence, a health care industry news source.
At that hearing, an exchange between FDA analysts and a Colorado doctor underscored the problem. FDA officials asked Dr. Kevin Chapman, who was testifying on behalf of the American Epilepsy Society, how parents of epileptic children know how much CBD to give them.
“They’re making it up as they go along,” Chapman said.
The request for public comments about CBD research wasn’t much better, according to Mayl.
“It’s safe to say that in 4,500 comments, we did not receive a lot of hard data around the issues that we specifically requested comments on,” Mayl told a group of attorneys and regulators at a conference on Monday.