Stakeholders recently tuned in to the FDA webinar, "A New Way Forward for Cannabidiol and Other Hemp Products."
Zooming out, FDA wants Congress to come up with a new regulatory pathway for CBD–not food, not quite drug approval, but something closer to dietary supplements without being a dietary supplement.
The main speaker was Patrick Cournoyer, senior science advisor who leads the Administration’s Cannabis Product Committee. Norman Birenbaum, senior public health advisor, also joined the call to field questions toward the end.
Cournoyer noted that FDA embarked on a “fact-finding” mission in May 2019, an endeavor in which he said delivered “some important safety concerns.”
Is CBD safe enough?
The FDA says no. The agency highlighted its usual safety concerns, such as liver toxicity, drug interactions, male reproductive concerns and certain subpopulations at risk. Caffeine was also thrown into the mix. According to FDA, “studies suggest CBD may increase and/or prolong caffeine’s effects, which could be a problem for people who are sensitive to caffeine.”
US Hemp Roundtable General Counsel Jonathan Miller was quick to call out FDA’s reliance on the studies they cite. For example, Miller pointed out that one study referenced used high-dose, pharmaceutical-grade CBD formulations. Miller accused the agency of ignoring the growing body of evidence demonstrating the safety of CBD at lower amounts, such as those typically found in CBD dietary supplements and foods sold at retail.
“There are plenty of beneficial dietary supplements – vitamin D is a great example – that pose significant safety risks if consumed at high doses,” said Miller. “As Congress develops plans to ensure the regulation of hemp extracts such as CBD, it should focus its attention on how these products are typically used, and not be distracted by studies that imagine their gross over-consumption which is not a realistic concern.”
When asked about the “potential stance” that the FDA might take on synthetic cannabinoids, Birenbaum stated that FDA has noticed that this market has “rapidly emerged” over the past couple of years and that FDA has fielded reports of adverse events tied to products such as delta-8. He added that it’s “a serious public health issue and a solution is urgently needed. We are prepared to work with Congress on possible solutions.”
Harm reduction approach
FDA has concluded that this new legislative pathway will require a harm reduction approach.
“The existing pathways that we have for foods and supplements don’t really allow for risk or harm. If it’s shown to be harmful or we can’t really show that it won’t be harmful, then it’s not allowed to be there,” Cournoyer said.
However, Steve Mister, president & CEO of the Council for Responsible Nutrition (CRN) told NutraIngredients-USA that DSHEA provides a range of tools for FDA to use to mitigate risks and protect consumers while allowing access to safe botanicals such as CBD.
“On the call, FDA either downplayed or wrongly dismissed the abundant safety data it has received for low-dosage CBD. And it ignored the ample authority it has been given to regulate these products, opting instead to propose a new regulated category that will take approximately a decade to enact and implement. In the meantime, consumers are left to navigate the booming cannabinoid marketplace without the guardrails Congress intended, and FDA has already been given,” Mister said.
He added that the ‘New Way Forward for Cannabidiol’ call was not a way forward, but rather a series of excuses to step backwards from what Congress intended when it enacted the 2018 Farm Bill. “Frankly, CRN was frustrated and alarmed at the level of misinformation and misinterpretation of the law that FDA espoused,” said Mister.
“The agency’s proposed ‘harm reduction' framework raises more questions than it answers and is especially frustrating that this comes 5 years after passage of the Farm Bill of 2018,” said Loren Israelsen, president of the United Natural Products Alliance (UNPA).
New pathway or road to nowhere?
When addressing what a “new pathway” might look like, Cournoyer said it might involve a “basic” degree of regulatory oversight, including clear labeling that mitigates contaminant risks and limits for CBD content, along with measures to prevent accidental ingestion.
“What a new pathway could allow is for these types of products to be removed from, let’s say, the food regulatory category. So, they wouldn’t be regulated as foods, per se, and held to the same standards. They’d be subjected to a more permissive pathway, let’s say, that would allow them to be in formats that might to a regular user look something like regular food,” Cournoyer said.
“It’s really in Congress’ hands.”
Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA), told us that the Agency’s assertion that a new pathway is needed is ‘scientifically fictitious.’
“Canada set a consumption level for healthy adults, the UK set a temp level and the agency has done nothing but cast aspersions to protect pharma intellectual property. While cannabinoids may have unique chemistry–which a number of botanicals do–the laws of science and toxicology that are used in the NDI and GRAS process aren’t somehow ‘magically’ reversed or altered for one plant. If other governments can establish a daily level in foods/supplements with scientific and toxicological principles, FDA can as well, they just won’t,” stated Fabricant. “They want a new center, new money and new power to build an empire.”
During the call, it was stated that FDA believes the CBD industry–to include supplements, foods, inhalables, pet products, and cosmetic–is a $5 billion industry.
“[It’s] ironic that they can't review categories on a product-by-product basis, but they want to combine all hemp products (ingestible, animal, inhaled, etc.) in a new center. They can't be trusted to do it for one product, but somehow for every product in all manners of exposure they’ll do a better job?” questioned Fabricant.
Jane Wilson, AHPA Director of Program Development and staff liaison to the AHPA Cannabis Committee said that of most concern, "the presentation did not address the Agency’s position that the existing regulatory frameworks for conventional foods and dietary supplements are not appropriate for CBD. AHPA does not understand how FDA could have drawn such a conclusion, and we had hoped to gain some insights from this stakeholder call, but we did not."
The American Herbal Products Association said it will continue to advocate for a sensible regulatory pathway for hemp and CBD products "that is so sorely overdue."
New pathway appears longer
UNPA's Israelsen added: “The climate for a regulatory pathway of legal CBD sales now seems markedly longer, with the FDA’s recent statements made during their webinar.
"We continue to believe that CBD can and should be regulated within the current DSHEA framework. It is tempting to just throw up one's hands in frustration, but we will continue working with Congress and FDA because this continued stalemate is good for no one. While FDA states they cannot find a way to regulate CBD under current law, millions of consumers continue to use CBD and deserve a regulatory process that allows high quality products to be sold and the use of enforcement authority to remove non compliant products from the market,” he said.
More questions than answers
Despite the FDA’s ongoing fact-finding mission, there doesn’t appear to be any solid conclusion. As one stakeholder put it: “We have more questions than answers.”
Cournoyer noted that even if the FDA was able to collect a “full data package” on CBD, at the end of the day, the acceptable daily intake would be so low it would “not be useful to the marketplace as it now stands.”