Sundlof feels industry's NDI pain
This article was originally published in The Tan Sheet
Executive Summary
FDA's Center for Food Safety and Applied Nutrition currently rejects 80 percent of the new dietary ingredient notifications it receives "because industry doesn't really understand what we require," says center Director Stephen Sundlof. The NDI guidance is "still under review ... but we are pressing to get that out and we know that the industry really wants to have that guidance," Sundlof said at the Food and Drug Law Institute's annual conference April 22 in Washington. Supplement industry stakeholders have long said an NDI guidance would be a key incentive for developing new products, and Sundlof said he realizes publishing the guidance "would be really helpful" to industry. The recent switch by Sens. John McCain, R-Ariz., and Byron Dorgan, D-N.D., from sponsoring a bill that would put new burdens on the industry to backing legislation that requires FDA to complete the NDI notification guidance "as soon as possible" also could compel CFSAN's work (1"The Tan Sheet" March 15, 2010)