FDA Strikes Down First Batch of NDI Guidance Complaints, Says Burden on Firms is Minimal

In the August 19 Federal Register, FDA commented on several complaints thus far submitted to the agency relating to new dietary ingredient (NDI) draft guidance. Notably, FDA disagreed with complaints that the agency has underestimated the time and cost required for filing NDI notifications.

FDA disagreed with allegations that the agency has significantly underestimated the time required to generate data for a NDI notification. FDA estimates this task should take 20 hours. By contrast, comments have argued, the time could range between 100 to 350 hours.

In its disagreement, FDA stated: “The Agency stands by its estimate of the paperwork burden resulting from §190.6 [of the Food, Drug, and Cosmetic Act]…The Agency believes that there is minimal burden on the industry to generate data to meet the requirements of the premarket notification program because the Agency is requesting only that information that the manufacturer or distributer should already have developed as the basis for its conclusion that a dietary supplement containing an NDI will be reasonably expected to be safe.” The agency says it stands by its 20-hours-per-submission estimate.

FDA’s forecast that it will receive a mere 55 notifications annually was also questioned. However, FDA argues that its estimate is accurate and based on the average number of notifications it has received in the last three years-77 notifications in 2008, 39 in 2009, and 48 in 2010.

Industry concern is that if FDA receives more notifications than it can process in a timely manner, FDA may become delayed in delivering responses, beyond the 75-day premarket notification period that covers the time of submission to the time of response. Industry has stated that FDA could receive far more notifications than it estimates-especially if notification requirements are product- rather than ingredient-specific, which would require that companies submit a far higher number of notifications.

Another compliant regarded FDA’s assumption that notifications would not require any capital costs. FDA responded negatively to this, stating the agency considers capital costs to be “costs for equipment, machinery, and construction that, if not for FDA’s request or requirement, the respondent would not incur.”

Moreover, it stated, “Capital costs do not include costs to achieve regulatory compliance with requirements not associated with the information collection. Hiring consultants to extract and summarize information for NDI notifications, paying for full-text scientific journal articles, and obtaining legal review of NDI notifications are costs associated with developing information that the manufacturer or distributor uses to satisfy itself that a dietary supplement containing an NDI is in full compliance with section 413(a) of the FD&C Act; thus, these costs are not a capital cost because they are costs associated with achieving regulatory compliance with requirements of the FD&C Act, not costs associated specifically with filing a notification under §190.6.”

Finally, regarding the argument that FDA underestimated the burden of notification procedures under §190.6 because it did not take into account provisions of the new draft guidance, FDA disagreed, stating, “The notification requirements set forth in §190.6 remain unchanged.”

Nutritional Outlook thanks Harry Rice, PhD, for the tip.