The FDA has authorized marketing of two vaping devices and tobacco-flavored refills made by Logic Technology Development LLC, the vape product arm of Japan Tobacco International (JTI). These are the only vaping products authorized by the agency since Vuse Solo became the first in October 2021—more than five months ago.
The FDA gave nods to the Logic Power and Logic Pro, and tobacco-flavored refills for both. Premarket Tobacco Applications (PMTAs) for both devices’ menthol refills remain under FDA review, as have nearly all menthol applications submitted to the agency. Logic submitted PMTAs for the Power and Pro devices and refills in 2019. They were among the earliest submissions—more than a year before the Sept. 9, 2020 PMTA submission deadline.
Logic received Marketing Denial Orders (MDOs) for other flavored refills, according to the FDA. Since those flavors are not currently being marketed, they are not included on the FDA’s PMTA lists. According to Filter’s Alex Norcia, Logic said it is “reviewing the FDA’s determination and rationale before taking further action.”
Dozens of smaller vaping companies have challenged MDOs for non-tobacco flavors in court, but so far none of the tobacco companies or tobacco-associated vaping companies that submitted PMTAs have taken action to protect flavored products receiving marketing denials.
Also today, the FDA authorized sale of the Logic Vapeleaf heated tobacco product (HTP) and unflavored tobacco refill capsules for the device. The Vapeleaf is the only FDA-authorized HTP other than Philip Morris International’s IQOS, which is currently not being sold in the U.S. because of a patent dispute.
The Vapeleaf is sold in other countries under JTI’s PLOOM TECH brand. Some PLOOM TECH products are based on technology JTI bought from the company now known as PAX Labs, which was spun off from Juul Labs in 2017. The original PAX product was also sold under the Ploom name.
The Logic Power is a rechargeable cigalike-style device with traditional screw-in cartomizer refills. The Logic Pro is a vape pen with drop-in sealed capsules that hold 1.5 mL of e-liquid. Vaping360’s 2019 review found the Logic Pro to be a solid choice for a no-frills eGo-style vape pen.
Neither the Logic products authorized today nor the Vuse Solo own a substantial share of the U.S. vaping market. The most popular mass-market vape products, like the JUUL and Vuse Alto pod-style vapes, remain under FDA review.
In a statement announcing the FDA actions, new Commissioner Robert Califf repeated the Campaign for Tobacco-Free Kids talking point that “millions of youth are using these products and getting addicted to nicotine,” and endorsed the FDA Center for Tobacco Products’ surprise 2021 decision to authorize only tobacco flavors unless manufacturers produce extraordinary evidence that flavored products will not attract youth use.
Did you see the release letter? I think the glaring subtext here is flavored tobacco products will not make PMTA, but unflavored might. There are always hidden messages in FDA rulings and releases. I believe the message here is forget about flavors including menthol. A good example is only the tobacco flavored products passed and their flavored products all recieved MDOs. Flavored tobacco products seem to be a thing of the past.
Yes, I wrote about that last summer.