The US Food and Drug Administration (FDA) has previously estimated that it takes about 20 hours to extract and summarize relevant information required to prepare an New Dietary Ingredient (NDI) notification.
However, following consultation with its members, CRN has estimated that the time demands will be between 100 and 350 hours, and that this “only reflect[s] the time necessary to extract and summarize the relevant information from the company’s files”, and does not include data collection.
“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),” write Douglas MacKay, ND, VP of scientific and regulatory affairs, and Taylor Wallace, PhD, senior director of scientific & regulatory affairs in a letter to OMB.
“If this were the case, the time and resource burden would be significantly higher than 100-350 hours,” they added.
Disagree without a reasonable basis
According to FDA (Federal Register, August 19, 2011), the agency is only requesting safety information that the manufacturer or distributor should already have in its possession, and that he time required to generate data is a “minimal burden on the industry”.
“CRN members with experience submitting NDI notifications have responded with thoughtful comments; however, FDA, with no actual experience extracting and summarizing the necessary information, has decided to disagree without a reasonable basis,” write Drs MacKay and Wallace.
“FDA continues to use uninformed assumptions to derive the 20 hour estimation for extracting and summarizing relevant information required to prepare an NDI notification in light of the collective data provided by CRN members who are among those companies that submit NDI notifications annually.
“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,” they add.
Please click here to read the full letter.