WASHINGTON — The U.S. Food and Drug Administration (FDA) will hold its first public hearings May 31 on how it might regulate CBD (cannabidiol) products.
“Interest continues to skyrocket,” Miriam Guggenheim, co-chair of the food, drug and device practice group for Washington-based Covington & Burling, told CNBC. “It is not fringe anymore, which doesn’t mean mainstream companies are ready to jump in. But they want to be prepared to do so once the legal landscape is clarified.”
The FDA has repeatedly cautioned that the rulemaking process is a long one—and specifically that the hearing is not about making a decision but instead is an opportunity for FDA officials to hear from the 140 stakeholders scheduled to testify.
Still, there are a number of areas that might provide clarity for convenience retailers. Here are four questions to watch for going into the hearing:
- Will Any “Antis” Speak Up?: Thus far, there seems to be an almost shocking amount of support for CBD products from both regulators and health experts. Last year, the World Health Organization went so far as to say, "To date, there is no evidence of recreational use of CBD or any public health related problems associated with the use of pure CBD.” Yes, there have been calls for oversight of health claims and ensuring manufacturers are being transparent about what’s in their products. But there hasn’t been the kind of “anti” movement common in tobacco, vape or alcohol. Will there be testimony from anti-cannabis or anti-CBD players? If not, that should ease concerns of mainstream retailers and companies worried about the PR of entering the cannabis space.
- Will There Be a Push to Age Restrict?: Somewhat related to the first question, the FDA has, to date, focused its attention on CBD being added to food, beverages and other “ingestible” products. It has not yet clarified if these products will be restricted by age. Technically, it is probably on Congress to do so (at least if we’re following tobacco rules). But the industry will still be watching to see if age restrictions (and/or self-service restrictions) enter the conversation. Some clarity would be helpful for retailers trying to determine just where this product will live in the store.
- Who Can Sell CBD?: With states such as Colorado and Washington legalizing recreational marijuana, there have been fairly severe limitations put on where those products can be sold. Licenses have to be obtained, with a steep list of requirements that more or less prohibit traditional retailers from taking part in that business. Again, that hasn’t yet been a part of the conversation, but is it possible that some will push to keep CBD in-house in a similar way? Or will the FDA look at limiting these products to age-restricted locations (as is being done with flavored vaping products)? It’s definitely something to keep an eye on so convenience industry stakeholders can respond during the public commenting period (which lasts through July 2).
- Where Does the New Commissioner Stand?: Before leaving the FDA, former commissioner Scott Gottlieb made it fairly clear that if Congress wanted a speedy solution to the CBD issue, it needed to act, and not wait on the FDA. But how does the new acting commissioner, Ned Sharpless, feel? Again, the session is largely for listening, but expect to see some indication of whether or not Sharpless’ FDA will continue the calls for Congress to act.