The FDA faces a court deadline of tomorrow, September 9, to issue Premarket Tobacco Product Application (PTPA) orders for every brand of e-cigarette on the market. The Covid shutdowns led to an extension to the original deadline.
It may sound counterintuitive for e-cigarettes that are already being sold to have to a "premarket" applications. But the rule is the result of a court order involving challenges to the legality of e-cigarette sales.
Until now, e-cigarettes have been sold despite no official FDA approval. Critics have blamed e-cigarettes and the "vaping" trend for harming the health of youth.
The FDA has been issuing approvals along the way for some products whose companies have submitted applications.
The agency has already issued warning letters to companies that missed the deadline to submit their applications.
But even if companies get the official green light, their products could ultimately be pulled from the market pending an overarching decision yet to come from FDA: should the products be allowed at all? The FDA has been analyzing the public health impact of e-cigarettes and related products and could ultimately withdraw any marketing approvals that are issued.
According to the FDA:
On August 8, 2016, FDA’s tobacco authorities were extended to all “deemed” tobacco products (except for accessories of deemed tobacco products), such as e-cigarettes, cigars, hookah tobacco, pipe tobacco, nicotine gels and certain dissolvables. These authorities include the requirement that deemed products that meet the definition of a new tobacco product must receive premarket authorization from the FDA to be legally marketed. Consistent with a court order, applications for premarket review for certain deemed new tobacco products on the market as of August 8, 2016 were required to be submitted to FDA by September 9, 2020. 1 For companies that submitted timely applications (by September 9, 2020), FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by FDA on the application.FDA