The Food and Drug Administration (FDA) held a hearing May 31 to receive public comment on CBD, and industry stakeholders say the agency’s forthcoming guidance will likely take aim at developing industry standards and regulating label claims.
The nearly 10-hour hearing saw more than 100 speakers provide testimony about the vast array of experiences and facets of the industry from the past few years.
“[The hearing covered] everything from the consumer experience to the challenges that the consumer faces in finding quality products and navigating what a quality certificate of analysis looks like, what the different vernaculars that are out there really mean, what different structure function claims are and how they should and shouldn’t be used, and of course, a lot of clinical-based medical research from medical organizations,” said Derek Thomas, vice president of business development for Veritas Farms, a 140-acre hemp farm, CBD product manufacturer and brand in Pueblo, Colo., that packs, labels and ships its products directly from its farm. The company’s chief operating officer and in-house legal counsel attended the hearing, but did not testify. “It was really this unique, big stew of industry experience from all of the different facets of the industry.”
For the Veritas team, the hearing offered valuable insight into the consensus on CBD, and the company sought to see where its understanding of the industry aligned with and differed from that of others.
While the FDA did not indicate which areas of the industry it might regulate or what those regulations might look like during the hearing, Meghana Shah, partner at law firm Eversheds Sutherland and co-lead of the firm’s Cannabis Industry Team, said the agency’s questions and remarks to speakers showed where its main concerns might lie.
“I think we’re going to see regulations around labeling, … and I think those could focus on … special populations, dosing [and] consistency across labeling,” Shah said. “One thing that really jumped out at the hearing was that the market is inconsistent. Numerous stakeholders testified that there are some really high-quality products, and then you have some potential bad actors [in] this unregulated market [that] put forth … products that don’t contain the amount of CBD that they say they do, don’t contain any CBD at all, or contain synthetic or other adulterants or other substances that shouldn’t be in there or shouldn’t be in there in the proportion that they’re in the product. A lot of the evidence presented was around safety and uniform protocol.”
One of FDA’s main concerns, she said, will likely be developing unified standards and regulations to weed out these bad actors.
“A lot of people … were testifying about standards that already exist, like the ISO standards [and] other third-party, international … standards that would apply to manufacturing that I think could be adopted [by the CBD industry],” Shah said.
The hearing also demonstrated the need for more research on the impact of CBD, particularly on special populations such as pregnant women and children, she added.
The Veritas team would like to see the FDA step in to regulate other areas of the industry, as well, such as the vernacular in the space.
“What is the agreed-upon definition of [these words that we’re using] when we present them to consumers, when we talk about them with our testing facilities and other manufacturers?” he said. “There needs to be this foundation of understanding for us to really grow. [The FDA should] set guidelines for what these different words mean that have been developed over the past few years.”
Label claims also need FDA oversight, Thomas added. “Some of them are so egregious and mind-blowing and outstanding that they’re almost criminal in intent. You see claims about cancer and all these other outlandish and completely unsubstantiated claims. It’s bringing a consumer in, [but] they’re not getting the result from that claim, and then not only have they not improved whatever condition they were looking to improve, but now they’re turned off from hemp oil and CBD in general. So, these brands that are out there doing this don’t realize what an injustice they are causing, but it really is a pervasive issue that needs to be mitigated. While we do know that full-spectrum hemp oil can be very beneficial, we can’t be out there talking about it in ways that are unsubstantiated. So, that’s another problem that we’re hoping the FDA will help clear up.”
While the timeline for formal policymaking is unclear, the public comment window is open until July 2, Shah said, and nearly everyone who testified at the hearing urged the FDA to act swiftly.
In the meantime, Veritas is continuing to constantly monitor its marketing. The company works with both in-house and third-party legal counsel to understand the best approach, Thomas said.
“Ultimately, the consumer needs some kind of guidance in their journey, but we can’t be doing unsubstantiated things,” he said. “So, it’s a tightrope, but it’s really not that hard to walk because there are so many things that you can talk about when it comes to full-spectrum hemp oil and CBD. Sharing the story of the endocannabinoid system can be beneficial to the consumer. … So, we’re not making claims to specific disease states or structure function claims, as the FDA likes to call them, but we are giving the consumer insight into the science behind this that is proven, and then we encourage them to go on and do additional research.”
Companies in the space should start evaluating their practices and whether their products will be compliant under the FDA’s forthcoming regulations to prepare for FDA oversight, Shah added.
“I think if I were a company that manufactured CBD food products, what I would be most interested in and concerned about in terms of the impact of the regulations is how it’s going to impact my product continuing to be able to come to market,” she said. “What’s the possibility of recall? I think there’s some possibility of that based on the way this industry works where there’s sometimes limited piecemeal guidance as the regulatory framework is worked out.”
Veritas is looking forward to the clear federal regulations that will replace this piecemeal guidance, Thomas said. “It almost sounds counterintuitive, but we’re certainly excited for some kind of regulation and we’re hoping it’s the appropriate regulation from the federal level. Hopefully that will encourage the states that haven’t fully embraced this new product, this new category, yet. Hopefully that will get them to get on board, as well, and this can really be a move into the standard consumer packaged goods space, where it belongs."