In a presentation at this week’s American Herbal Products Association webinar on the FDA’s controversial new draft guidance on NDIs, Alan Feldstein of New York-based legal firm Collins, McDonald & Gann said this insistence would place “an impossible burden” on industry.
He added: “There is no logic in requiring each and every company issuing NDI notifications for each and every product containing an NDI.”
According to the guidance, NDI notifications are applicable only to the specific manufacturer that submits them and firms making even small changes to formulas/target groups/conditions of use for supplements containing NDIs must prepare fresh notifications for each new supplement.
A raw materials firm supplying the NDI to multiple customers was far better placed to amortize the cost, rather than supplying it to 100 different customers that would then be required to submit individual NDI notifications, even if they were all making identical products, added Feldstein.
The FDA was concerned about how the NDI could interact with other ingredients in different formulations, he acknowledged. But in reality, the risks were very low, he claimed, challenging the FDA to look at adverse event report records and see “if there is a statistically significant amount where an ingredient approved as safe in one product caused safety issues in another”.
Conventional foods vs dietary supplements
Paul Rubin, a partner at Washington DC-based law firm Patton Boggs, said the guidance went “far beyond what is legally justified”.
His biggest gripe related to the FDA’s stance that an ingredient was only ‘grandfathered in’ if you could prove it was a dietary ingredient that had been marketed in dietary supplements prior to 1994 - and not in conventional foods.
The fact FDA was now insisting that an ingredient’s presence in a conventional food prior to 1994 was “irrelevant” was both baffling and inconsistent with the Dietary Supplements Health and Education Act (DSHEA) that the guidance was designed to clarify, he claimed.
“The Congressional definition of new dietary ingredient does not contain any limiting language that excludes conventional foods.”
What will enforcement look like?
Anthony Young, a partner with Washington DC-based law firm Kleinfeld, Kaplan and Becker said the FDA was “covering itself” with its broad definition of NDIs, but in reality had neither the time nor inclination to hunt out all of the firms that should submit notifications.
Instead, he predicted, it would focus on pursuing cases where AER reports suggested a safety issue or where firms were marketing something that was “unpronounceable” and obviously brand new, most likely in the sports nutrition field, rather than something that had been around for years but should probably submit an NDI because extraction methods had changed.
“The FDA will pick its cases carefully.”