Industry experts: FDA avoiding CBD classification is 'a baby step’

On Jan. 26, FDA announced that it needs to develop a new regulatory pathway to regulate products containing CBD. After determining that the existing frameworks for both food products and supplements were “inappropriate,” the agency said in a release that it will work with Congress to develop “a new way forward.”

Among those who were shocked by the announcement were Kathy Knutson, Ph.D., a food scientist and safety expert who works with companies producing foods, drinks, candies and lozenges containing CBD and/or other forms of cannabis. She’s also the author of the guide, "Food Safety Lessons for Cannabis-Infused Edibles," and said she has long thought that FDA’s existing framework for food and drink could effectively be adapted for CBD products.

“I have been saying that the FDA will take what it already has and just use that. Why reinvent the wheel? I’m surprised that they couldn’t make it work,” Knutson said. “Meanwhile, we have been desperate for regulation because we’re living in a void at the federal level. It’s been a huge question just hanging out there.”

In the short to medium term at least, the answer to that question is that there is no answer. Response within the CBD industry has been varied, with many producers expressing disappointment, and trade organizations like the Natural Products Association (NPA) going so far as to call it an “astonishing dereliction of duty.”

“There are some folks who are really frustrated and saying, ‘What in the world is going on? I have no certainty. My investors are screaming at me. How much longer do we have to endure this gray zone where we can’t differentiate ourselves?’” said David Vaillencourt, senior quality consultant at The GMP Collective, a firm that works with cannabis companies to establish and scale GMP (good manufacturing practice) standards.

Vaillencourt admitted, however, that he was neither shocked nor discouraged by the announcement. “This is actually the clearest thing the FDA has said to date,” he said. “I honestly would have been more surprised, based on their history, if they jumped in and said, ‘Yeah, it’s a dietary supplement or a food ingredient.’”

For this reason, both experts said they consider FDA acknowledging the need for a new solution to be a very small step in the right direction.

“Simply saying that they want a different type of pathway is a baby step,” Knutson said. “I don’t think it’s a bad thing. It’s getting the conversation rolling, and it’s just part of the evolution of where we’re going to end up in terms of regulation at the federal level.”

Both Vaillencourt and Knutson said a major reason they remain optimistic is because they have been impressed with the ability of the CBD and cannabis industries to “self-police” and establish standards of production and safety. This gives them hope that they will be able to be active participants in the process of determining how, ultimately, FDA treats CBD and cannabis-infused food and drinks.

“For being such a young industry, coming from the shadows, we are doing an exceptional job,” Vaillencourt said. “FDA just said, ‘We need a new lane,’ and as scientists, we now have the opportunity to create that framework and hand it to them on a silver platter.”

FDA’s announcement, however, officially means that the clock is ticking. “I see it as a major opportunity for us, but we have to act,” Vaillencourt explained. “We can't just sit there and say, ‘Well, we're making it work.’ If we don't get a clear message showing them, ‘This is what we're doing, this is how we're doing it and we agree on this as the best practice to do it,’ then FDA and Congress are going to tell us what to do eventually—and we might not like that.”

Further adding urgency to the situation, Knutson added, is the continued growth of the CBD and cannabis industries—with or without regulation.

“We’ve always been hanging,” she said. “The industry will continue to grow because absence of regulation has never stopped it from growing. The industry is ahead of the FDA.”

Nick Collias is a writer and editor with over a decade of experience working in the health and fitness industry. From 2016 to 2021, he was the host of the Bodybuilding.com Podcast, interviewing elite athletes and training thought leaders on a wide range of exercise, nutrition and lifestyle topics. Additionally, he has worked for the last 20 years as a longford print and online journalist, as well as a book author, ghostwriter and editor.