Washington, D.C.—Tomorrow, from 8:00 AM EDT to 6:00 PM EDT, FDA will hold a public hearing—to be webcast, here and here—entitled “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds.” The intent is to allow stakeholders to provide scientific data and information regarding compounds like CBD.
Among the associations who will be speaking: the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and the National Cannabis Industry Association (NCIA).
WholeFoods Magazine talked to Andrew Shao, Ph.D., interim SVP of scientific & regulatory affairs at CRN, to get an idea of Industry priorities. Dr. Shaw opened by saying that “The main issue is a provision in the law that’s basically serving as a roadblock to getting food and dietary supplements containing CBD to the marketplace. It was included with the intent of protecting pharmaceutical companies and their investments, in terms of money and research: If a product—’article,’ according to the provision—if an article has ever been approved or even studied as a drug, it cannot be sold as food or supplements.” This is, of course, why FDA holds its current position, which is that CBD is illegal. However, as Dr. Shao noted, Congress has given FDA the discretion to work around that. “Our aim will be to focus on that, first and foremost.”
The second issue, Dr. Shao told WholeFoods, is that because FDA is moving slowly, “We now have a market that is out of control. Companies that may not be familiar with the dietary supplements space are entering it, and may not be following regulations, which makes their products unsafe for consumers.”
This worry is shared by Daniel Fabricant, Ph.D., president and CEO of NPA. CNBC paraphrased Dr. Fabricant as noting that FDA has allowed more than 1,500 new CBD products to hit the market over the past three years, entirely unregulated. “These companies aren’t your Fortune 100 companies,” he told CNBC. “These people in a lot of ways are fly by night.”
NCIA said in a press release that they, too, will be aiming to speed up rulemaking. Policy director Andrew Kline will be providing public comment and general context about the industry, answering questions, and highlighting work that NCIA and its allies have done on packaging, labeling, and testing that could inform FDA rulemaking.
Safety is the number one issue for FDA, understandably, and as Dr. Shao points out, FDA is fully backed in this area by responsible industry members, including those represented by CRN. “It’s important that we aren’t being misconstrued here,” Dr. Shao said. “We do care about safety, and feel that it is deeply important. The problem is that, right now, there is no regulatory framework to follow.” Once CBD is legal, Dr. Shao explained, and once there is some regulation in this space, existing safety enforcement measures can kick in. “But they can’t do that if CBD isn’t even legal yet.”
As to what to expect from tomorrow’s hearing? “Nothing substantive,” Dr. Shao said. “Tomorrow really is the starting point for FDA to hear different perspectives.” Hopefully, though, they’ll get the most important point: The three-to-five year process foreseen by former FDA commissioner Scott Gottlieb is much too slow. “Consumers and Industry need regulation and a framework,” Dr. Shao emphasized. “Taking years to work something out simply isn’t going to work.”
If you would like to submit a comment on the matter, you can do so here.