Is FDA open to entertaining an NDI for CBD products?

Speaking with NutraIngredients-USA via video, Mister said that during a fireside chat with Steven Tave, director of the Office of Dietary Supplement Programs at the FDA, during the recent CRN/ ACI Annual Legal, Regulatory & Compliance Forum on Dietary Supplements​, there was a willingness from Tave for the Agency to sit down and talk to some companies that are selling full-spectrum hemp extracts about the possibility of filing a new dietary ingredient (NDI) notification.

“Up until this point, the FDA had seemed pretty negative towards entertaining an NDI for CBD products – again, we’re not talking about isolates but the full spectrum,” ​Mister told us.

“To be clear, he [Tave] didn’t say, ‘absolutely, submit your NDIs’. I asked him about this provision in the definition of dietary supplement that creates the race to market between the pharmaceutical and the dietary supplement. ​

“If we look back to the lovastatin-red yeast rice case from the 1990s, there was a distinction made between red yeast rice containing naturally occurring levels of lovastatin [monacolin K] and the pure versions of the statin drugs. So, based on that comparison I said, ‘would FDA consider looking at full spectrum hemp products as not being the article studied in the pharmaceuticals?’. And he said, ‘That’s an interesting argument. We would certainly be willing to sit down with a company that was prepared to make the legal arguments that what they’re selling is not the article used in the drug. We [FDA] would be interested in having that conversation.’ ​

“I thought that was the first time we had heard any flexibility from the Agency on that point, and I know for a number of people who were part of that legal conference their ears perked up.”​

But NDIs need to be enforced and protected​

But if a company was to go through the effort and investment in submitting an NDI – and this applies to any NDI, not just a full-spectrum hemp extract – then there would need to be enforcement of the NDI provision, said Mister.

 “The point that we keep stressing with the Agency, and we had a conversation with FDA [this week] about this very topic, none of that works unless there is enforcement of the NDI provisions. ​

“If a company goes to all that effort and research to develop a product and bring an NDI to market, and get a non-objection letter, then FDA has to help protect that,” ​he said.

Mister added that it is not only about protecting the intellectual property of the company – which is certainly an important issue – but it’s also a public safety argument.

In the above video, Mister also discusses the importance of Master Files for NDI notifications, the strategy behind CRN’s recent citizen’s petition on CBD, FDA restarting GMP inspections, and the association’s success at the recent NutraIngredients-USA Awards where its Label Wise initiative won our Editor’s Award for Industry Initiative of the Year.