CBD is all the rage among certain product developers in the dietary supplement industry. But the molecule is still a source of angst for many industry stakeholders, some of whom participated in a ‘town hall’ style meeting at the recent Oxford International Conference on the Science of Botanicals held at the University of Mississippi. The meeting was put on by the National Center for Natural Products Research.
Drug development background
CBD, or cannabidiol, is a non narcotic fraction of cannabis. The molecule has been researched as a drug. English company GW Pharmaceuticals has filed INDs on it for a couple of applications. It is developing two drugs with trade names Sativex (an oral spray meant to deal with certain complications of multiple sclerosis including neuropathic pain) and Epidiolex (an anti-seizure medication aimed at certain forms of intractable childhood epilepsy).
FDA’s hardening stance
It is this drug development that is the major, immediate hurdle for CBD in dietary supplement development, according to the FDA. The agency ruled in 2015 that the prior INDs filed by GW Pharmaceuticals means the molecule cannot be used in dietary supplements. If it had been on the market ‘as an article in food’ prior to the IND filing date, that would not be the case. But FDA says it has received no information from industry to convince it that that is true.
FDA sent four warning letters to CBD companies in 2015 that hinged on illegal disease claims and sidestepped the issue of the ingredient’s legality. In 2016 the agency sent an additional eight warning letters to CBD companies that mentioned claims language as well as the IND issue. Last year, the agency sent four more warnings that also specifically cited the IND issue.
What’s the enforcement picture?
Then there is the presence of the source plant