FDA “Underestimates” the Time Needed to Create an NDI Notification: Complaint Sent to White House OMB

The Council for Responsible Nutrition has taken its criticisms of FDA’s new dietary ingredient (NDI) draft guidance to the Office of Information and Regulatory Affairs (OIRA), part of the Office of Management and Budget. The complaint centers on CRN’s allegations that in its NDI guidance, FDA grossly underestimates the amount of time it will take for companies to compile successful NDI notifications. CRN says that while FDA projects this should take 20 hours, a likelier estimate, based on feedback from the association’s member companies, is 100 to 350 hours. CRN targeted OIRA because part of the office’s job is to “[review] federal regulations [and] reduce paperwork burdens…”

In the Federal Register on August 19, FDA struck down complaints that the agency had underestimated the time burden, stating that its estimate of 20 hours excludes the amount of time it takes companies to gather evidence that its ingredient is safe. FDA stated that companies should already have this information in possession and that its estimate for creating NDI notifications accounts only for the administrative time needed to compile the information.

Specifically, 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 said it stands by its 20-hours-per-submission estimate.

However, in its letter to OIRA, CRN explains that its 100-to-350-hour estimation-which CRN had submitted as part of its guidance comments to FDA on July 25-did not include the time required to generate safety data and only accounts for the time to put a notification together. It says that if its estimate were also to include the amount of time necessary to generate safety evidence, “the time and resource burden would be significantly higher than 100 to 350 hours.”

In its letter to OIRA, CRN states, “In FDA’s response to industry comments published in the August 19, 2011, Federal Register, the Agency appears to have mistaken industry’s estimates to include the time necessary to generate the data (e.g., performing required safety and toxicology studies)…CRN is submitting these comments to the Office of Management and Budget (OMB) to make it clear that our estimates of 100 to 350 hours only reflect the time necessary to extract and summarize the relevant information from the company’s files.”

It also stated, “CRN members shared their experiences specific to the paperwork burden resulting from §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 FD&C Act and §190.6. CRN would like to make it clear that this estimate does not include the time required to generate the data to meet the requirements of an NDI notification, which is the information the company should already have developed as the basis for its conclusion that a dietary supplement containing an NDI will reasonably be expected to be safe.”

Read more about the time it takes to complete an NDI notification.

In other news, FDA has extended the deadline for submitting NDI draft guidance comments from October 3 to December 2.