Altria announced today that it would pull its pod vapes MarkTen Elite and Apex from the market until the FDA approves them via a premarket tobacco application or decides that “the youth issue is otherwise addressed.” They will also pull all flavors of their cigalike products MarkTen and Green Smoke except tobacco, menthol, and mint.
The move comes in response to the FDA’s mid-September demand that JUUL Labs and four major tobacco companies that also sell vapor products deliver plans within 60 days to eliminate sales to teenagers. Altria also announced support for federal Tobacco 21 legislation, which JUUL Labs also supports. Currently, six states and hundreds of municipalities have laws restricting tobacco purchases to buyers 21 and older.
The target of the FDA’s demand was clearly JUUL, since the tobacco companies’ vapor product sales are a tiny part of their business. JUUL has captured more than 70 percent of the convenience store/gas station vaping market over the last year, and has significantly grown the size of that market. The JUUL is a superior pod-based vapor product to those made by the tobacco companies, but more importantly it is actually threatening their primary source of income: cigarettes.
The Altria move is designed to put pressure on JUUL to eliminate its flavored products too. The tobacco giant knows that the upstart vape is cutting into its cigarette sales and threatens to undermine future sales of its heat-not-burn tobacco product IQOS. Altria has applied to the FDA for marketing approval for IQOS. Because IQOS is classified as a cigarette, Altria will not be allowed to sell it in any flavor except tobacco and menthol. Flavored vapes like JUUL are a clear threat to IQOS and to Altria’s cigarette sales.
FDA Commissioner Scott Gottlieb seems convinced that flavors are the driving force behind youth uptake of vapes, and has threatened to ban or restrict e-liquid flavors except tobacco. He has also suggested the agency might restrict online sales, and sales of vapor products in convenience stores.
The FDA is already in the process of regulating vaping flavors, and earlier today at a Food and Drug Law Institute conference FDA Center for Tobacco Products director Mitch Zeller said that flavors rulemaking has been fast-tracked. Most observers expect the agency to institute restrictions on e-liquid flavors, even though a major survey earlier this year showed that adult vapers overwhelmingly prefer fruit and dessert flavors to tobacco and menthol.
The FDA intended to ban flavors as part of its 2016 Deeming Rule, but the Obama White House nixed the flavor ban for unknown reasons. Since then the agency has been under constant pressure from tobacco control groups and Democratic politicians to use its deeming authority to restrict flavor choices. There is also a current bipartisan Senate bill that would ban flavors except tobacco.
Unlike the tobacco companies, vapor products depend on flavors. Altria’s move signals to the FDA that it will gladly play along with the agency’s plan to restrict availability and move vapor products into a ghettoized vape shop market. Even if the FDA doesn’t approve IQOS, a tobacco landscape without effective flavored vapor products being sold right next to cigarettes would leave the tobacco companies in control of the market. And when the FDA then restricts flavors, vape shops will wither and die.
Post time: Oct-26-2018