How to Prioritize Potential NDI Notifications

Photo © iStockphoto.com/csepei aliz

Industry responses to last month’s release of FDA’s revised new dietary ingredient (NDI) draft guidance have ranged from the cautiously receptive to the borderline apocalyptic. But regardless of just how big of a burden the latest NDI guidance would place on industry, all ingredient firms will likely want to consider their top priorities when submitting NDI notifications (NDINs).

Of course, much uncertainty still surrounds the need for NDINs of certain ingredients, especially since so many of the guidance provisions have to do with changes that have happened since the Dietary Supplement Health and Education Act of 1994 (DSHEA). With more than 20 years behind us, it’s bound to be difficult to establish whether ingredient manufacturing processes have changed since 1994, or sufficient materials still exist to show an ingredient was even on the market before DSHEA.

Nonetheless, there are still a few clear starting points for firms looking to stay on FDA’s good side.

High-Risk Ingredients

From the perspective of an ingredient supplier or manufacturer, the first step in addressing the need for new NDINs may be to look at the most successful ingredients or products.

“Start with your best-selling products, the products that you really care the most about in terms of revenue, in terms of sales, and do an NDI analysis,” advised Ashish Talati, a member of law firm Amin Talati & Upadhye, during a September–7 webinar hosted by the Council for Responsible Nutrition (CRN; Washington, DC). Once a firm ensures its top ingredients pass FDA’s NDI muster, then it’s a matter of prioritizing any other ingredients based on the likelihood a NDIN is required, Talati said.

In some cases, ingredient firms will likely identify ingredients that clearly require an NDIN, possibly because there is no history of marketing before 1994 or there is no NDI exemption due to presence in the food supply. These go on a high priority list, Talati said. After that, consider ingredients for which the regulatory status may be a bit murkier under the revised NDI draft guidance, he explained. This would include old, pre-DSHEA ingredients that may actually require a NDIN due to a chemical alteration or a change in manufacturing process since 1994, such as the use of a different extraction solvent.

“I think this is where companies need to pay more attention, because you could be thinking you’re using an ingredient that’s been sold for 20 or 30 years, but your supplier could be using a different extraction method,” Talati advised manufacturers. “If you don’t know it, obviously you’re not going to address that issue.”

FDA Resources

But aside from what a firm should prioritize in its NDI analysis, there’s also the question of what FDA’s priorities will be in taking enforcement action. Several industry experts have noted that the agency tends to use the NDI provision as an administrative tool only when an ingredient raises safety issues.

“If you look at the warning letters that [FDA has] written over the last five years, and there have actually been quite a few now where they have cited the failure to file a NDI notification in the warning letter, they don’t typically do that for something unless they have a genuine safety concern about it,” Steve Mister, president and CEO of CRN, told Nutritional Outlook. For instance, he noted that FDA has invoked the provision in recent warning letters against DMAA, DMBA, and Acacia rigidiula.

“But you don’t see them using it willy nilly for just any ingredient out there,” Mister said. “It’s only when they already have a safety concern and it allows them to act. And I think that’s how they’re apt to move forward after the guidance, is that they will continue to use the NDI provision where they already have real concerns about safety.”

Talati shared Mister’s take on FDA’s priorities, adding that commonly used ingredients have a “very low” risk of FDA enforcement action.

“I don’t anticipate that FDA is going after any ingredient that it certainly does not have any safety concern [for],” said Talati. “In the short term they just don’t have the resources to do that. That doesn’t mean that you as a company shouldn’t file it. It’s just, what is your risk?”

Read more:

Waters Still Murky for Omega-3s in NDI Draft Guidance?

Would FDA’s NDI Guidance Really Cost Industry Billions of Dollars?

Company Submits First NDI Master File to FDA. Plus, Will Master Files and Piggybacking Really Be Useful in Practice?

Michael Crane
Associate Editor
Nutritional Outlook Magazine
michael.crane@ubm.com