Perspective: FDA’s Progress on Review of Tobacco Product Applications
By Mitch Zeller, Director of the FDA’s Center for Tobacco Products (CTP)
February 16, 2021
"We are working to review applications as quickly as possible. However, given the unprecedented number of applications and other factors discussed above, the likelihood of FDA reviewing all the applications by Sept. 9, 2021 is low. We will continue to allocate our resources with the goal of working as quickly as possible to transition the current marketplace for deemed products to one in which all products available for sale have undergone a careful, science-based review by FDA. We will focus resources on products where scientific review will have the greatest public health impact,
based on their market share, while also committing to providing an opportunity for review to all companies regardless of size, prior to Sept. 9, 2021,
at which time they risk FDA enforcement per FDA’s guidance."
"based on their market share"
So I was surprised to see the first rejections to be smallish companies, or, maybe not... targeting flavored products for annihilation announcement first to appease the ANTZ while sitting on those with a big market share (Vuse, Juul, Blu etc.) To announce approval before the deadline...
Morgan Stanley thinks September 9th could be a big day for the tobacco sector due to an anticipated FDA decision.
Analyst Pamela Kaufman expects favorable decisions for many of the big names like Altria (MO +0.1%), British American Tobacco (BTI +0.6%), Swedish Match (OTCPK:SWMAF -2.2%) and Imperial Brands (OTCQX:IMBBY +0.8%) for their various brands. Some of those companies could see a significant competitive advantage if their product is approved, while a rival product is rejected. While there is a chance that the FDA extends the timeline on the decision, Kaufman thinks big determinations are more likely.
Aug. 11, 2021
Tobacco stocks could soar on September 9th due FDA decision on PMTA | Seeking Alpha
So the waiting question is what happens on Sept 10th to vape shops selling non-approved items?