Today, December 9, 2016, FDA sent out a notification that the deadline for domestic manufacturers to submit Establishment Registration and Product Listing has been pushed back from December 31, 2016 and are now due June 30, 2017. This change has been formally noted in Revised Guidance published in November. See here for Revised Guidance

“The guidance has been revised again to clarify that for U.S. manufacturers of newly regulated tobacco products who first manufactured those products prior to August 8, 2016, the FDA does not intend to enforce the submission deadline for establishment registration and product listing as long as submissions are received by the FDA on or before June 30, 2017.”

This is an interesting development, and raises the question of whether the more onerous submissions coming due in the next few months will also have extended deadlines.

Please contact Tom Norby or Lindsey Streicher for more information.