FDA has grossly underestimated the burden of its New Dietary Ingredient (NDI) notification process on the dietary supplement industry in terms of time resources, according to the Council for Responsible Nutrition (CRN), Washington, D.C., which submitted comments to the Office of Management and Budget.

FDA estimated the average time necessary to generate data to meet the requirements of an NDI notification at 20 hours. However, CRN members with experience filing NDI notifications have provided estimates that significantly exceed that amount of time.

“CRN members shared their experiences specific to the paperwork burden resulting from §190.6 and reported committing 100-350 hours to extract and summarize the relevant information from the company’s files, and present it in the format that will meet the requirements of section 413 (a) of the FD&C Act and §190.6.

CRN emphasized that estimate does not include the time required to generate data needed to meet the requirements of an NDI notification (e.g., performing required safety and toxicology studies). “Our estimates of 100-350 hours only reflect the time necessary to extract and summarize the relevant information from the company’s files.”

FDA continues to use “uninformed assumptions” to derive its estimation of 20 hours, CRN added. “CRN feels strongly that FDA has grossly underestimated the NDI notification process’ burden on the dietary supplement industry in terms of time resources. Accordingly, CRN seeks consideration of its comments by the OMB in determining the actual burden on industry.”