Restrictions on the use of flavors for “Logic” vaping products in the United States

In one of its sales authorization decisions, the Food and Drug Administration (FDA) indicated that it only authorized tobacco-flavored e-cigarettes under the Logic brand of the manufacturer Japan Tobacco International (JTI), with the issue of menthol remaining unresolved. A decision applauded by anti-tobacco campaigners, who nevertheless deplore the exceptions granted to menthol flavors.

After authorizing the sale of certain Vuse products by RJ Reynolds (British American Tobacco/BAT) in November 2021, the FDA also granted authorization on March 24 to the Logic brand, owned by Japan Tobacco International, to market its electronic cigarettes. As with Vuse, only tobacco flavors were authorized, with flavors of other flavors having to be withdrawn from the market under penalty of prosecution.[1]. Pending a decision on the menthol issue, Logic products with menthol flavors will still be allowed to be sold. The FDA has also specified that Logic products should not be marketed to young consumers and that this point will be closely monitored. Acquired by JTI in 2015, Logic currently represents just under 1% of the U.S. e-cigarette market, which is dominated by the tobacco majors with their JUUL, Vuse, Blu and NJOY brands.

Controversial arguments about the benefits of vaping products

Some of the arguments put forward by the FDA to explain these two decisions are, however, perplexing. The FDA justifies the authorization of sale of electronic cigarettes from the two manufacturers by invoking the fact that they have proven their effectiveness in helping dependent adults quit smoking. However, as the president of the American Medical Association (AMA), Gerald Harmon, pointed out after the authorization granted to Vuse, this therapeutic indication is not sufficiently clear and has not yet been formally validated to date by independent studies.[2].

The FDA also highlights the benefits of e-cigarettes in reducing the number of cigarettes smoked daily. However, it has long been demonstrated that simply reducing smoking is insufficient to prevent the onset of tobacco-related diseases and that the therapeutic benefits of e-cigarettes can only be understood from complete smoking cessation.[3].

While the FDA acknowledges the role of fruity and sweet flavors in e-cigarettes as an incentive for young people to start using e-cigarettes, it nevertheless considers that starting e-cigarettes does not lead to starting smoking, even though this point has not been formally established and data from independent studies show the opposite.[4].

Tolerance to menthol flavors

The FDA also says that tobacco flavors would not be a gateway to vaping for youth, but it is not ruling on menthol flavors. By delaying its decision on menthol flavors, it is leaving nearly 30% of e-cigarette flavors on the market, which are very popular with youth. The Truth Initiative, for its part, points out that the FDA's restrictions on flavors since 2019 have greatly benefited menthol-flavored products, which doubled their presence among e-cigarettes between 2019 and 2020.[5]. Truth Initiative is calling on the FDA to remove all menthol-flavored tobacco and nicotine products from the market as quickly as possible.[6].

New Governance for the FDA

The FDA has once again made a point of reminding consumers that its marketing authorization decisions do not in any way constitute an “approval” of e-cigarette products, as some manufacturers are tempted to claim. It has also emphasized that all tobacco and vaping products are dangerous and potentially addictive. As is often the case, the exceptions and loopholes in the regulations issued by the FDA are exploited by the tobacco and nicotine industries. Menthol flavors represent a considerable stake in the initiation and maintenance of addiction, on which manufacturers are banking and retreating.[7].

Keywords: United States, FDA, Logic, Japan Tobacco International, flavors, menthol

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[1] FDA Issues Decisions on Additional E-Cigarette Products, FDA, published March 24, 2022, accessed March 28, 2022. [2] Harmon G, FDA made the wrong choice in allowing Vuse marketing, AMA, published November 19, 2022, accessed March 28, 2022. [3] Berlin I, Is risk and harm reduction effective and what are its limits in tobacco?, Alcohology and Addictology, 2017;39(2):128-137. [4] Owotomo O, Stritzel H, McCabe SE, Boyd C, Maslowsky J, Smoking Intention and Progression From E-Cigarette Use to Cigarette Smoking, Pediatrics, 2020;146(6). [5] Weak restrictions on flavored e-cigarettes lead to explosive menthol sales, Truth Initiative, published September 30, 2020, accessed March 28, 2022. [6] FDA's on Logic's e-cigarette products underscores urgent announcement need for decisions on top e-cigarette brands including 75% of the market and should include menthol flavors, Truth Initiative, published March 25, 2022, accessed March 28, 2022. [7] United States: Manufacturers focus advertising efforts on menthol e-cigarettes, Generation Without Tobacco, published on February 21, 2022, consulted on March 12, 2022. National Committee Against Smoking |