WASHINGTON—The Council for Responsible Nutrition (CRN) told the Office of Management and Budget Review (OMB) that FDA has grossly underestimated the burden of submitting new dietary ingredient notifications (NDINs) in terms of time and resources. In comments to the OMB, CRN said FDA’s 20-hour estimate is well below its own calculations. FDA said a NDIN will take 20 hours; however, CRN estimated at least 100 hours per NDIN.
“FDA, with no actual experience extracting and summarizing the necessary information, has decided to disagree without a reasonable basis," wrote Douglas MacKay, ND, vice president, scientific and regulatory affairs; and Taylor C. Wallace, Ph.D., senior director, scientific and regulatory affairs, CRN.
FDA’s estimated burden on the dietary supplement industry to generate data to meet the requirements of NDINs was published in the Federal Register on June 3, 2011 (docket number FDA-2011-0410).
On July 25, 2011, CRN submitted comments on behalf of its more than 75 industry members—many of which have filed NDI notifications—providing estimates for the time to prepare NDINs that significantly exceed FDA’s estimate of 20 hours. CRN members shared their experiences specific to the paperwork burden resulting from 21 CFR 190.6, and reported committing 100 to 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 Food, Drug and Cosmetic (FD&C) Act and §190.6.
Further, CRN noted this estimate does not include the time required to generate the data to meet the requirements of an NDIN, which is information the company should already have developed as the basis for its conclusions that a dietary supplement containing an NDI will reasonably be expected to be safe.
CRN submitted the comments to OMB to make it clear that its estimates of 100 to 350 hours per NDIN only reflects the time necessary to extract and summarize the relevant information from the company’s files.
FDA responded to CRN in the Aug. 19, 2011, Federal Register, but CRN said the agency again mistook the industry’s estimates to include the time necessary to generate the data; specially, CRN said FDA underestimated how long it would take to perform required safety and toxicology studies.
CRN disagreed with FDA’s Aug. 19 statement: “There is minimal burden on the industry to generate data…because the agency is requesting only that information that the manufacturer or distributor should already have developed as the basis for its conclusion that a dietary supplement containing an NDI will reasonably be expected to be safe."
CRN is a Washington-based trade association representing the responsible dietary supplement industry. To hear more of FDA’s and CRN’s takes on the burden on industry, attend the NDI Town Hall meeting on Oct. 12 from 2 to 5 p.m. at SupplySide West, and visit INSIDER’s NDI Immersion Center.
