Logic has been granted FDA authorization for sale of a number of their vape products in the US market. The Japanese vape and e-cigarette company, owned by Japan Tobacco International (JTI), is now the second e-cigarette company to have been given this approval by the FDA. News of the decision was released last week on March 24th.
The approval authorizes Logic to market a number of e-cigarettes and heat-not-burn products including their Logic Vapeleaf, Logic Power and Logic Pro brands and their devices. These electronic nicotine delivery systems (ENDS) will now be able to be freely marketed within the United States, with strict restrictions still in place over their flavored e-liquids.
At the time of writing, the FDA had already denied most of Logic’s flavored products, with only menthol-flavored products pending a decision from the agency.
What You Need to Know About the Decision
As this is an FDA authorization, it grants only the ability for Logic and their subsequent brands to be sold and marketed within the United States. Their marketing has also been given strict restrictions, citing the relationship between underage tobacco usage and youth exposure to tobacco advertising as the main reason for this. These strict operating parameters will result in stern monitoring by the FDA for all marketed products, ensuring they do not breach the outlined statutory or regulatory requirements outlined.
“The FDA will closely monitor how these ENDS products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers – including youth – using these products,” according to the FDA release statement.
It is important to note that this does not mean this array of Logic’s products themselves are “FDA approved”, with an official statement expressing this. “While today’s action permits these specific products to be sold in the U.S., it does not mean these products are safe nor are they ‘FDA approved,’” the FDA expressed in their news release.
According to the official FDA news release, the agency came to this decision purely based on the possible tobacco harm reduction (THR) potential that the Logic product line may offer. “These products were authorized after the agency’s review of the product applications concluded, among other things, that the likely benefit for adult smokers who significantly reduce their cigarette use (or who switch completely and experience cigarette use cessation) outweighs the risk to youth, provided that the company follows post marketing requirements to reduce youth access and youth exposure to their marketing.”
This is the chief reason why only non-flavored e-liquids have been permitted to market. The FDA made it clear in their news release that they believe the availability of flavored e-liquids is a driving factor behind young people taking up vaping. “As evidenced through data collected via the National Youth Tobacco Survey, compared to users of non-tobacco-flavored ENDS products, young people are less likely to start using tobacco-flavored ENDS products.
The only other similar FDA approval of this nature is that of the Vuse Solo. This approval came in October 2021. The nature of these approvals hold two significant features in common. One of these commonalities between the two authorized brands is the incredibly low market share they possess. The Vuse Solo is an extremely outdated piece of technology, which is not widely used by the vaping community. On the side of Logic, their products hold only a 1% market share within the United States. The other similarity is that both companies are owned by a big tobacco brand.
It is believed that without the significant backing of cigarette sales of JTI, Logic may never have been able to acquire this authorization. Despite a vape brand receiving what appears to be a step in the direction of progress, Greg Conley, the president of the American Vaping Association, believes this decision does not help vaping. “If JTI did not have cigarette sales to subsidize their minimal effort offerings in next-gen products, market forces would have caused them to stop selling these products years ago,” Conley stated.
As mentioned, the approved products consist of JTI’s Logic Vapeleaf, Logic Power and Logic Pro brands. Logic Vapeleaf is a heated tobacco product sold under JTI’s PLOOM TECH. This non-heat technology was purchased by JTI in 2017 from a branch off of Juul Labs. Logic Power is the company’s e-cigarette offering. And finally, Logic Pro is the brand’s disposable pod system.
Logic and their brands, Logic Vapeleaf, Logic Power, and Logic Pro have received authorization by the FDA for marketing and selling in the United States. As the FDA made clear, the benefits to adult smokers attempting to reduce cigarette usage outweighs the risks of underage youth. The FDA also mentioned their attempts to allow only the marketing of non-flavored e-liquids, as they have cited flavored e-liquid as a significant driving factor behind underage vaping.
With significant backing from the sale of cigarettes by JTI, this authorization can be seen as only a miniscule victory for the vaping community as the PMTA process remains to be unforgiving to the many other products that form the market. This is especially true when considering the very small market share Logic boasts within the United States. The best takeaway from this event is that it appears the FDA is slowly beginning to accept the benefits of vaping when considering tobacco harm reduction. However, with only two authorizations of this nature in the past two years and synthetic nicotine regulations becoming stricter, it is unclear if this can be considered progress.