WASHINGTON — Two recent decisions by theU.S. Food and Drug Administration (FDA) could slow the path of cannabidiol (CBD) products into the mainstream. But an analysis of the actions suggests the way to move forward will be to proceed as planned.
In August, the FDA sent letters rejecting two manufacturers’ intentions to market full-spectrum hemp products, including CBD products, as a new dietary ingredient (NDI). While the manufacturers, Irwin Naturals and Charlotte’s Web, are not major players in the convenience-store industry, the rejection does have broader implications for anyone making or selling CBD products.
To better understand exactly what happened, what it means for retailers and what happens next, CSP Daily News reached out to two regulatory experts. Here is their analysis …
What is NDI and why is it important for CBD products?
Even though the 2018 Farm Bill deemed that hemp was no longer subject to the Controlled Substances Act, the FDA maintained authority over hemp and the cannabinoids found in it as ingredients. According to Robert Hoban, a member and co-chair of the Cannabis Industry Group at the Detroit-based Clark Hill law firm, the only parts of the cannabis plant currently approved for food or supplements by the FDA are hemp seeds and pressed hemp seed oil (not extracted hemp oil).
That’s where the NDI designation comes in.
“The former two FDA commissioners have said it’s folly to think this is going to go away, and they should or will create a pathway for CBD. [But] the pathway already exists,” Hoban said. “It’s through NDI/new dietary ingredient and/or through the formal recognition of these materials as GRAS (generally recognized as safe) for supplement purposes.”
The process entails engaging with the FDA to document that an ingredient has been extensively studied and does not cause harm. “The FDA engaged Charlotte’s Web and Irwin Naturals in this long process,” Hoban said. “They played ball, hired experts, put together the studies, … then the FDA ultimately rejected the NDI notification for full-spectrum hemp.”
Why did the FDA reject the applications?
Perhaps no amount of data or proof that CBD does not cause harm could have gotten NDI approval due to the fact that the FDA had already approved CBD as a drug product, specifically as part of seizure medication Epidiolex. Because of this, CBD cannot be used in dietary supplements pursuant to the dietary supplement exclusion provision in the Federal Food, Drug and Cosmetic Act.
“Technically that’s how the law works,” Hoban said. “If the NDI had been submitted before the Epidiolex submission, it had a much better likelihood of approval. (However), FDA compounded things by mischaracterizing these products as prescription drugs then ignored, dismissed and downplayed all of the evidence that these full-spectrum hemp products are safe.”
“When the FDA [says CBD] is an approved ingredient for food and supplements, you’ll see every major CPG manufacturer having a product which features CBD.”
The rejection letters also called out the amount of CBD as a concern, stating the hemp product was “carefully designed to ensure consistent levels of CBD, and that it is produced from your proprietary [redacted] that provide robust levels of CBD.”
Jonathan Havens, a partner for Philadelphia-based law firm Saul Ewing Arnstein & Lehr and a former FDA regulatory counsel, said the “robust” description by the FDA “doesn’t seem grounded in reality.”
“The suggested daily intake of the tincture product—intended for adults—provides a mere 19.5 mg of CBD,” he said. “Compare that with the starting dose of Epidiolex—a drug product for a pediatric population—(of) 5 mg/kg/day. For a 16-kilogram child, that would be 80 mg per day. The agency’s ‘concerns’ about the adequacy of safety evidence in the NDI notification probably say less about the submission and more about FDA’s approach to this category.”
What does the rejection mean for the CBD industry?
Both Havens and Hoban were of the opinion that the FDA’s blanket rejection of two such detailed NDI applications may discourage CBD-makers from engaging with the FDA in the future.
“It sends a message to the industry not to worry about the FDA rules and processes,” Hoban said. “Just keep doing what you’re doing, because there is no pathway to sell your product under federal law.”
Havens added, “Unless a marketer makes fairly aggressive therapeutic claims, suggests that FDA has approved its products, commits serious GMP (good manufacturing practices) violations, or the like, it’s unlikely the agency would take enforcement action simply for selling a CBD supplement.”
What’s next?
Still, it’s not impossible that CBD may one day be marketed via NDI. If another manufacturer is willing to attempt the NDI application, Havens said, the FDA’s response “leaves open the possibility that a hemp extract containing a non-standardized amount of CBD might not be subject to the FD&C Act’s drug exclusionary provision. Hemp has been a food ingredient for hundreds if not thousands of years, far before CBD was studied as a drug. An extract from hemp should be able to be marketed as long as the amount of CBD in it hasn’t been standardized or intentionally enhanced.”
If not through NDI, Hoban believes the FDA needs to create a process to differentiate between CBD as a drug ingredient as opposed to CBD as an ingredient in food or supplements.
“Then there’s the distinction of isolated vs. full spectrum, synthetic vs. natural. There’s how many milligrams per units,” he said. “Until they come up with this, everyone’s hands are tied. Continued uncertainty for investors, business operators and most importantly, consumers.
“When the FDA comes out and says it’s an approved ingredient for food and supplements, you’ll see every major CPG manufacturer having a product which features CBD and/or other nonintoxicating cannabinoids,” Hoban added.
Havens, however, continues to believe that this certainty won’t come from the FDA at all.
“FDA’s statements in the letters further support the contention that unless Congress intervenes, FDA will continue to stall on CBD reform,” he said.