NDI filings coming in at expected rate, FDA says, but questions on GRAS process remain

05-Jul-2018 - Last updated on 05-Jul-2018 at 17:31 GMT

The confused picture on New Dietary Ingredients became a bit clearer this week when FDA updated the public docket on filings and said it does not expect there to be a significant change in how many companies are choosing to go through the process.

Until quite recently, the public docket on NDI Notifications maintained by FDA included only one filing for this year. When queried, FDA said at the time the docket was up to date, which raised the question of whether the industry was starting to have serious second thoughts about the utility of the process. It also raised the question of whether companies were concluding that putting together a self-affirmed GRAS dossier was a safer bet for getting some regulatory cover for a new ingredient they planned to bring to market.

The public docket, which can be viewed here, now contains listings for seven NDI Notifications filed this year. FDA spokesperson Corinne Newhart said there is a 90-day window during which the NDI filing remains confidential before it goes up on the website. There was anomalous spike last year, when more than 100 new notifications flooded in. This reportedly was the result of a major retailer requiring NDI Notifications on a host of new products from its suppliers.

“We do not anticipate that the number of NDI Notifications this year will differ meaningfully from the number received in recent years,” Newhart told NutraIngredients-USA.

Fewer farcical filings

One thing that does seem to have changed, and for the better, is the number of notifications to which FDA has not objected. (The agency doesn’t actually ‘approve’ the safety of a new ingredient.) This could in part be attributed to companies taking advantage of pre filing meetings offered by the agency to forestall some of the unnecessary or poorly compiled notifications that have come in to the agency in the past.

“We continue to engage with stakeholders regarding potential NDI Notifications and we encourage firms that are preparing to submit a notification to meet with our staff before they do so. Our preliminary data reflect that notifications are more likely to have a successful outcome when firms take advantage of the opportunity to engage with our staff before submitting their notification,” Newhart said.

Attorney Marc Ullman, of counsel with the firm Rivkin Radler, has participated in several NDI Notifications over the years. He said he has noticed that the system seems to have matured somewhat.

“I have been told by FDA that they have been seeing fewer of the silly NDI notifications because people seem to be taking advantage of the pre notification procedure. As a result they get few facially ridiculous NDI notifications, like someone saying, ‘I want to do an NDI for vitamin C.’ That’s going to push the numerator down,” Ullman said.

“It is helpful that we are having improved communication with FDA on this part of the process,” he said.

Still, the number of NDI filings lags behind the number of new products in the market. The open secret in the industry is even if the NDI filing process seems to be functioning as it has been and could even be said to have improved somewhat, a number of companies are not choosing to go that route and are opting for the self-affirmed GRAS process instead. Newhart said FDA is fully aware of the situation.

“We have also been told that some firms choose to utilize the GRAS process rather than submit an NDI Notification. Under the law, notification is not required for a new dietary ingredient which has been present in the food supply as an article used for food in a form in which the food has not been chemically altered. An ingredient that is marketed pursuant to the self-affirmed GRAS process should have undergone the safety evaluation that is necessary for that process. In order for a dietary ingredient to be lawfully marketed based on its GRAS status, the conditions of use for the dietary supplement product should be carefully reviewed to ensure the ingredient is reasonably expected to be safe. We encourage firms to consult with the agency if they have questions,” she said.

More clarity needed on GRAS alternative

Ullman said there is little clarity on what ‘present in the food supply’ means. Can you take your new ingredient, put it in 1,000 demo nutrition bars, and fulfill the requirement that way? Without a better definition on this, Ullman said the self-affirmed process runs the risk of being degraded into a mere loophole.

“As positive as I am about what is going on with the prenotification meetings, I continue to be baffled by FDA’s lack of clarity on this. I think this is something the agency absolutely needs to speak to,” he said.

“I have personally seen situations where companies get a ‘bad day’ letter from FDA with serious, substantiative questions on their NDI. And they show up with a self-affirmed GRAS on the same ingredient and the ingredient is being sold in supplements shortly thereafter,” he said.

“There seems to be some disconnect between the GRAS program and the NDI program and that needs to be fixed. The agency needs to speak with one mind on the issue,” said Daniel Fabricant, PhD, president and CEO of the Natural Products Association.