More Time For NDI Guidance Comment: Health And Wellness Industry News Roundup

FDA extends the comment period through Dec. 12 for its revised drat guidance on new dietary ingredient notifications it published in August, more than four years after it began revising the original draft met with widespread questions and criticism. The agency's Center for Food Safety and Applied Nutrition said in an Oct. 4 Federal Register notice that requests for 30- and 90-day extensions of the comment period "conveyed concern that the current 60-day comment period does not allow sufficient time for interested parties to develop a meaningful or thoughtful response to the draft guidance" and some "mentioned that the requests for comment may necessitate in-depth research and/or require supporting data to provide meaningful responses." CFSAN states that extending the comment period for 60 days from Oct. 11 – docket FDA-2011-D-0376 – should allow "adequate time for interested persons to submit comments without significantly delaying finalizing the guidance." (Also see "Revised NDI Notification Draft Guidance Shrinks Divide Between FDA And Industry" - HBW Insight, 12 August, 2016.)

Graceleigh Inc. recalls all lots of its Sammy’s Milk Baby Food because of possible presence of Cronobacter, a bacteria that can cause severe and sometimes fatal blood infections or meningitis in infants and because the product may not provide adequate nutritional levels of iron. The Newport Beach, Calif., firm on Sept. 30 it is conducting the voluntary recall following FDA’s determination that testing to confirm the absence of the bacteria was not performed and due to the absence of a label warning that it contains low iron and supplementation may be necessary, although the product meets FDA’s minimum requirement for iron content