Emily Saunders, Regulatory Operations Manager, takes a look at the potential delay to the Tobacco Product Directive (TPD3) and the future of TPD notifications.
Nicotine
On May 10th, 2016, FDA issued a final rule extending its tobacco product authority to all tobacco products (except for accessories of newly deemed tobacco products), including electronic nicotine delivery systems (ENDS) – for example: e-cigarettes and vape pens.
Tobacco products for which timely premarket submissions have been submitted by the applicable compliance date will be subject to a ‘continued compliance period’ for 12 months after the initial compliance period. Once the continued compliance period ends, new tobacco products on the market without authorisation will be subject to enforcement.
We are therefore advising Manufacturers and Importers to take advantage of this continued compliance period with timely premarket submissions.
**** UPDATE: The dates described have now been updated by the FDA Click Here for these new dates ****
