CRN Pushes Budget Office To Seek FDA Review Of NDI Notification Costs

The Council for Responsible Nutrition has gone to the White House budget office with its challenge of FDA’s estimate of the cost to comply with its new dietary ingredient notification guidance.

CRN submitted a comment to the Office of Management and Budget Sept. 19 contesting FDA’s Aug. 19 estimate that supplement firms need 20 hours to compile and submit an NDI notification.

The trade group estimates that a firm needs 100 to 350 hours to prepare an NDI notification.

With its comment, CRN seeks to prompt OMB to start a process that could lead to FDA aligning its NDI notification draft guidance more with the industry’s understanding of the requirement.

“This NDI draft guidance has potentially far-reaching implication for the future of the industry. We just want to be sure that we provide feedback every chance we can,” said Douglas “Duffy” MacKay, CRN’s VP for scientific and regulatory affairs.

Chief among the implications is FDA’s contention that under the Dietary Supplement Health and Education Act, NDI notifications are required for all products made with a new ingredient, rather than only for the first use of an actual new ingredient (Also see "Industry Pushes FDA For Narrower Policy On NDI Notifications" - Pink Sheet, 8 Aug, 2011.).

Regulatory Burden

FDA and other federal agencies must submit to OMB estimates on industries’ costs for complying with regulations. From CRN’s comment, OMB could determine FDA’s estimate does not accurately reflect the supplement industry’s compliance burden and that costs linked to the NDI notification requirement are “economically significant” – an impact of at least $100 million on the industry.

According to OMB, economically significant regulatory actions are returned to agencies for a more detailed assessment of the likely benefits and costs of the action, including a quantification of the effects, and an analysis of “potentially effective and reasonably feasible alternatives.”

“The regulation has to be reasonable in light of the burden it’s placing on industry,” said food and drug attorney Marc Ullman, a partner at Ullman, Shapiro & Ullman in New York.

Ullman pointed out OMB returned FDA’s supplement good manufacturing practices final rule with questions about the economic impact before clearing the rule in 2007. In comments following the proposed GMP rule's publication, stakeholders characterized the requirements for finished product batch testing as exhaustive and expensive (Also see "Dietary Supplement GMPs Back To FDA; Publication Expected In June" - Pink Sheet, 14 May, 2007.).

Preparation Exceeds Estimate, Says CRN

CRN submitted comments to FDA in August disagreeing with the agency’s NDI notification estimate published June 3. However, FDA dismissed CRN’s and other stakeholders’ comments contesting the estimate and directed the commenters to submit statements to OMB if they chose to continue their argument (Also see "FDA Defends Estimate For NDI Notification Preparation" - Pink Sheet, 29 Aug, 2011.).

“We really think it’s a clear underestimate,” said MacKay. He and Taylor Wallace, CRN’s senior director of scientific and regulatory affairs, submitted the OMB comment.

He said FDA’s view of NDI notifications could stem from a lack of experience among agency staff in working with the information.

“They review them and they know how much time it takes to review them. That’s fair, but they don’t know how long it takes to develop them,” MacKay said.

On the other hand, after stakeholders with “real-life experience” submitted comments, “it’s odd that [FDA] would just completely ignore them or assume that we were misinterpreting something,” he added.

CRN also argues FDA’s estimate does not accurately represent the division of time between research on an ingredient’s safety and actual preparation of an NDI notification.

CRN agrees with FDA that the information for an NDI notification should be available from research a firm has completed on an ingredient. However, the trade group argues preparing the information to submit to FDA requires much more time than the agency estimates, even though this work does not require repeating the safety research.

“It doesn’t include the time necessary to run your studies and do your safety evaluation, toxicology studies and such,” MacKay said, adding that CRN “thought it was important just to restate clearly that, in fact, our estimate is just the time needed to extract and summarize the required information.”

Ullman observed that if NDI notifications could be completed as quickly as FDA estimates, the agency would receive more of them.

After investing in research for a new ingredient and in manufacturing a product, a supplement firm should not cut corners on the NDI notification it must submit to FDA within 75 days of launching the new product.

“It is prudent to have a lawyer and an independent consultant work to assemble the package,” Ullman said. “Your odds are greatly increased” that FDA will not have questions about a notification, he added.

FDA appears to expect firms merely to “take their raw data, make copies of it, put a couple staples in it and send it in,” he said.

By Malcolm Spicer