Supplement ingredients being sold without undergoing the NDI notification process rank among top concerns for FDA's Center for Food Safety and Applied Nutrition, according to center Director Robert E. Brackett.

"Apparently new dietary ingredients are being used in some supplements without notices being sent to the agency, and we're particularly looking here - where we see this happening - at what enforcement options can be done," Brackett said Oct. 4 during the Council for Responsible Nutrition's annual conference in Scottsdale, Ariz.

Imported new dietary ingredients used in products without prior notification to FDA are an area of particular interest to the agency, according to Brackett.

FDA is looking at "what we can do if you have a product coming from another country and there are new dietary ingredients listed on them and [the companies] have not informed the agency the way they're supposed to and then used questionable dietary ingredients," he said.

The new dietary ingredient program, which Brackett characterized as a "safety gatekeeper," deals with ingredients not marketed before the passage of the Dietary Supplement Health and Education Act in 1994.

Producers of new dietary ingredients must notify the agency 75 days prior to marketing the product. "In many cases, this is not being done," Brackett stated.

New dietary ingredient notifications are essential to the agency to establish "a reasonable expectation of safety" for new ingredients, he explained. In the absence of an agency guidance, though, some companies provide incomplete submissions, which result in FDA objections.

The agency is still working on issuing an NDI guidance, which has been a recurrent priority for the center in recent years (¹ Also see "CFSAN Seeks Recommendations On Fiscal 2008 Priorities" - Pink Sheet, 9 July, 2007., p. 11). The agency anticipates completing the guidance by the end of fiscal year 2008.

The Complete NDI

Many cases of incomplete submissions come from "new companies who just don't know how to package the materials the way that they should," Brackett said.

"The burden is on the notifier - that is the industry - to establish a reasonable expectation of safety for the product that they're going to market, and the burden is on us at the FDA to establish whether the evidence that's been submitted to us actually establishes that safety," he said.

"In some cases, we have a fair number of these that do not do this and it doesn't necessarily mean that the ingredient is unsafe, but just that evidence has not been provided," Brackett stated.

"One of the biggest problems that we've seen is often the notifier doesn't really know what they should tell us and so we're going to hopefully establish more of a rapport with the industry so that when these submissions do come, they can be more complete."

Brackett outlined some of the information CFSAN looks for when reviewing a new dietary ingredient notification for safety data which, if absent, may result in the notice receiving an objection.

"When we do an NDI review there are several different aspects that are looked at, one of which is the identity of the substance, if the substance can be identified. Is the substance even eligible to be called a dietary supplement under the act? ... Does the data and information submitted to the agency establish that the ingredient will be reasonably expected to be safe?"

"In some cases, the identity of the actual ingredient was unclear. They may have included a mixture or they may have been a bit vague about what was actually being declared," he said.

FDA also seeks to determine if the "safety information that's provided relates to a product in commerce."

In some cases, "the safety of the substance was unrelated to the ingredient. It was something similar, it was an analogue, but it really wasn't established for that ingredient itself," Brackett explained.

Additionally, history-of-use information on the ingredient provided by the notifying party may be inadequate, he said.

"So having all that material together sometimes helps the notifier in having a better package to submit to us and makes things go a lot faster for us," Brackett said.

- Jessica Lake (j.lake@elsevier.com)

NDI Notification Failures Concern FDA; Complete Submissions Urged

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