In a recent revision to the guidance on Ingredient Listings, FDA has postponed the deadline for the Ingredient Listing–which was previously due on February 8, 2017.

However, FDA recognizes that some manufacturers of newly deemed products are not familiar with the forms for listing ingredients and, therefore, may need additional time to complete them accurately. In addition, we are aware that some manufacturers may need to prepare and submit multiple lists. Therefore, at this time, for manufacturers and importers of newly deemed tobacco products (21 CFR part 1100) that were introduced into interstate commerce on or before August 8, 2016, FDA does not intend to enforce the requirement to submit ingredient information according to section 904(a)(1) until August 8, 2017.

(See Guidance at 14, emphasis added)

The new deadline is set for August 8, 2017, or February 8, 2018 for small manufacturers. This will come as good news to those in the industry who were grappling with the onerous challenge of compiling data to complete these applications.

Find the guidance here: Revised Guidance

For more information, please contact Tom Norby or Lindsey Streicher.