"These materials are intended to help simplify the process for manufacturers and distributors, resulting in more complete NDINs submitted to the FDA and facilitating the agency’s scientific review," FDA said. 

While we welcome FDA’s attention to the important and outstanding issues associated with the NDIN requirement, the Guidance is incomplete and does not do enough in describing the master file system," said CHPA's Duffy MacKay.

FDA said the guidance responds to the supplement industry’s requests for specific guidance on recommendations about Master Files for new dietary ingredient notifications (NDINs).

FDA's guidance is to help manufacturers and distributors of new dietary ingredients (NDIs) and dietary supplements prepare and submit new dietary ingredient notifications (NDINs).