IPCPR previously reported that because the Food and Drug Administration (FDA) believes blending pipe tobacco is “manufacturing,” retailers that plan to continue blending pipe tobacco should register with the FDA by December 31, 2016. However, earlier today (December 9), FDA extended the December 31, 2016 deadline to June 30, 2017 in certain circumstances. CLICK HERE to view the revised guidance.
A summary of the changes is below:
The FDA does not intend to enforce the submission deadline for establishment registration and product listing as long as submissions are received by FDA on or before June 30, 2017 for U.S. manufacturers of newly regulated tobacco products who first manufactured those products prior to August 8, 2016.
Persons who begin manufacturing newly regulated tobacco products in a domestic establishment on or after the August 8, 2016 effective date of the deeming rule must register and list immediately with FDA. For details on how to register and list CLICK HERE to view IPCPR's “FDA Compliance Update for Retailers.”
IPCPR believes that the extension of the registration and product listing deadline is a positive development for our members. We remain optimistic that the additional 6 months will afford FDA sufficient time to provide clarification on what constitutes manufacturing.