Last week the FDA announced a major shakeup to the agency’s policy on e-cigarettes which includes the de-nicotinization of cigarettes, and a PMTA deadline delay. Following that announcement, the FDA has now issued a guidance titled Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule, in order to formalize and explain this deadline extension.
This four year delay is considered by most a positive first step forward, as it gives everyone time to reevaluate and influence the current regulations into more sensible ones.
“The further extension of premarket review compliance deadlines covered by this guidance applies to all categories of newly regulated products that were on the market on August 8, 2016, including ENDS (e.g. e-cigarettes and e-cigars), hookah, pipe tobacco, and cigars. The compliance dates are being extended from November 8, 2017 (SE EX requests), May 8, 2018 (SE reports), and November 8, 2018 (PMTAs) to August 8, 2021 (SE EX requests, SE reports, and PMTAs for newly regulated combustible tobacco products, such as most cigars, pipe tobacco and hookah tobacco) and August 8, 2022 (SE EX requests, SE reports, and PMTAs for newly regulated noncombustible tobacco products, such as most ENDS or ecigarettes).” reads the guidance.
“The further extension of premarket review compliance deadlines covered by this guidance applies to all categories of newly regulated products that were on the market on August 8, 2016, including ENDS (e.g. e-cigarettes and e-cigars), hookah, pipe tobacco, and cigars.”US Food and Drug Administration
Under this new comprehensive plan for tobacco and nicotine regulation, the much disputed PreMarket Tobacco Applications (PMTA), will be delayed for four years until 2022. However as harm reduction advocates have pointed out, although a start, this motion is far from perfect.
A positive first step in the right direction
The extension only applies to existing products, as any new ones will still require a PMTA before they can go on sale. Additionally, there is also no change in the controversial grandfather date of February 2007, which is considered as one of the harshest aspects of the infamous deeming rule. Having said all this, this four year delay is considered by most a positive first step forward, as it gives everyone time to reevaluate and influence the current regulations into more sensible ones.
Reactions to the FDA’s tobacco plan announcement
