The agency added that this marketing authorization is not an MRTP. “Additionally, this action is not an authorization or indication of appropriateness to market these products as modified risk tobacco products.” On asking Professor of Medicine at the University of Louisville, and tobacco harm reduction expert Dr. Brad Rodu to clarify what all these seemingly contradictory statements mean, he told Vaping Post that for any “new” tobacco products, and all e-cigarettes are considered as such, there are two separate approvals from the FDA.
Rodu explained that the first approval is the Pre-Market Tobacco Application (PMTA), which allows the product(s) on the market, while the second “and optional approval” is the MRTP (modified risk tobacco product). “So far only Swedish Match’s General snus (for reduced risk) and Iqos (for reduced exposure) have achieved those,” he added.
The FDA stated that there is a public health benefit for adults who switch entirely from traditional cigarettes to these new products or significantly reduce their smoking. The agency added that this benefit outweighs the potential risk to youth, especially sincethe FDA emphasized that while the approval means that these products are considered “appropriate for the protection of public health,” this does not mean that they are safe or “FDA approved,”
Other Vuse applications
Previously, the FDA banned Vuse Alto menthol and fruit-flavored e-cigarettes due to their popularity among minors. This ban is currently being challenged in court by British American Tobacco, Reynolds’s parent company.
R.J. Reynolds has also just submitted its final Pre-Market Tobacco Product Application (PMTA) to the FDA, for its Vuse Pro e-cigarette device which features an age verification technology. This system uses a mobile application connected to a third-party provider, to verify the user’s age before the device can be unlocked for use. In a media release announcing the approval, Reynolds revealed that it has provided the FDA with nearly 80,000 pages of scientific data, including 97 scientific studies.
A mishandled process
Meanwhile, in the last couple of years, the FDA has been under scrutiny for its mismanagement of PMTAs. The agency has infamously fallen behind in reviewing the submitted applications, as well as failing to meet its own deadlines. In fact, the intended date to complete the reviews was set for the end of 2023, yet the process is still ongoing with no end in sight. Moreover, the agency has been sued for rejecting countless applications without properly reviewing them.
During this period, Vuse and other brands have been allowed to continue selling their products while awaiting the results of their applications. The FDA has authorized only a few products and rejected over 26 million applications.
The FDA is Blasted For The Way It’s Handling (And Not Handling) Its PMTA Process
