FDA NDI Notification Cost Estimate Widens Gulf With Stakeholders

Stakeholders widely criticize FDA estimates for the industry’s NDI costs – 20 hours to prepare a notification and no capital costs. Industry reps argue the agency’s evolving approach to NDIs will increase costs, and the two sides disagree over the role and cost of research.

Stakeholders say FDA steeply lowballs costs in its latest estimate for the burden on industry of new dietary ingredient notifications, further underscoring the gap between agency and industry over NDI issues.

The agency estimates a firm needs 20 hours to prepare an NDI notification and says no capital costs are associated with the compliance, in a notice on extending the agency’s collection of information conducted through NDI notifications published in the Aug. 26 Federal Register. FDA also estimates 55 NDI notifications to be submitted annually in the U.S.

The estimates are based on averages for the past three years and match the agency’s last round of estimates published in November 2011.

“There is a real disconnect between the numbers of NDIs and the amount of time it would take to put a submission together according to the notice in the Federal Register, and then the rhetoric that you hear out of FDA about each manufacturer being required to file an NDI and the amount of information they want in the NDI.”

– CRN President Steve Mister

Despite supplement industry stakeholders’ objections in 2011, FDA stuck to its estimates and the White House Office of Management and Budget endorsed those reflections of industry’s regulatory costs (Also see "FDA “Undercuts” NDI Guidance Opposition With Compliance Cost Estimate – CRN" - Pink Sheet, 21 Nov, 2011.).

FDA explains in the latest notice that it rejected the objections because the industry’s calculations inappropriately included firms’ research costs as part of their NDI notification burdens.

“In the past, commenters argued that our burden estimate is too low. We revisited this issue and believe [the industry’s estimate] included the time it takes to research and generate safety data for a new dietary ingredient,” according to the notice.

However, FDA adds that firms should research ingredients for a reasonable expectation of safety regardless of whether they plan to introduce an NDI. Under this argument, NDI notification costs are separate from and lower than a firm’s research costs.

Industry stakeholders contend their costs for NDI notifications are linked directly to their research on those ingredients.

Comments on the notice are due by Oct. 25. Following comments, FDA will submit the information for OMB review. The effective periods for information collection notices are set by OMB, often at three years but in some cases one or two years.

NDI Argument Expands

In July 2012 FDA said it would revise the NDI notifications draft guidance and would consult with supplement industry stakeholders, though the agency has not formally withdrawn the document published in July 2011 (Also see "FDA Revision Of NDI Draft Guidance Starts With Grandfathered List" - Pink Sheet, 25 Jun, 2012.).

One of the fundamental components of the disagreement is over the criteria for determining whether an ingredient should be the subject of an NDI notification. Stakeholders argue the requirements FDA proposes in the draft go well beyond the NDI provisions of the Dietary Supplement Health and Education Act, generally that ingredients present in the food supply at the time of DSHEA’s passage in 1994 can be used in supplements without notifications (Also see "Supplement NDI Draft Guidance Discussions Snagged On Basic Criteria" - Pink Sheet, 12 Jul, 2013.).

Now, the differences between the agency’s and the industry’s views on NDI costs compound the disagreement about the draft.

“There is a real disconnect between the numbers of NDIs and the amount of time it would take to put a submission together according to the notice in the Federal Register and then the rhetoric that you hear out of FDA about each manufacturer being required to file an NDI and the amount of information they want in the NDI,” said Council for Responsible Nutrition President and CEO Steve Mister.

“That disconnection illustrates the problem with the guidance,” he added.

FDA’s interpretation of DSHEA’s NDI language is reflected in the draft guidance and in agency officials’ contention that the industry should be submitting far more notifications than are being received at the Center for Food Safety and Applied Nutrition.

At a conference in June 2013, Division of Dietary Supplement Programs Director Daniel Fabricant said while the number of supplement products available in the U.S. has grown from 4,000 to more than 85,000 in less than 20 years since DSHEA was passed as a framework for supplement industry regulation, FDA has received only 450 notifications specifically addressing the use of new ingredients.

Meetings Positive, Forecast Unclear

Mister and Duffy MacKay, CRN VP for scientific and regulatory affairs, noted that stakeholders this year have had four meetings with FDA officials to share their ideas about revisions to the NDI draft guidance.

CFSAN Director Michael Landa and Fabricant have participated in the meetings for FDA.

MacKay said the sessions are one-way talks because FDA officials are not sharing any information that is not already public. “They’re really in a listening mode it. It really forces us to say, ‘This is what we’ve heard you say. This is what we think about it and here are some other ideas,’” he said.

“They can’t respond to those ideas necessarily, but I’m fairly confident that they’ve heard us. They’ve been given a chance to ask clarifying question and they will take very seriously the things that we put forth.”

Mister also described the meetings as positive and said signs point to FDA publishing a second draft guidance before proceeding to a final guidance. “We are optimistic, based on our conversation with the FDA over the year. … We’ve been told that it is a priority at the agency but we have no timeframe as to when we’ll see it.”

CFSAN officials declined to comment on when to expect another draft, or whether the agency will, in fact, post a second draft for comment before publishing a final guidance.

Food and drug attorney Wes Siegner, who was highly critical of the July 2011 draft guidance, says he does not expect a second draft to be available soon. Moreover, he does not expect FDA or the industry to cede ground in the argument.

“In my view FDA is kind of playing a waiting game. That draft guidance is so far off base, I don’t see how they can get to step two. The industry’s view versus FDA’s view are just miles and miles apart,” said Siegner, of Hyman, Phelps & McNamara in Washington.