FDA authorizes marketing of four menthol-flavored e-cigarette products

The Food and Drug Administration announced it authorized the marketing of four e-cigarette products in the United States through the premarket tobacco product application, or PMTA, pathway. The FDA issued marketing granted orders to NJOY LLC for four menthol-flavored e-cigarette products – NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5%, and NJOY DAILY EXTRA Menthol 6%. The two authorized ACE products are sealed, pre-filled, non-refillable pods that are used with the previously authorized ACE device, and the two authorized DAILY products are disposable e-cigarettes with a prefilled, non-refillable e-liquid reservoir. “Today’s authorizations mark the first non-tobacco flavored e-cigarette products to be authorized by the FDA. Importantly, each application is reviewed on a case-by-case basis and today’s actions are specific to these four products only – the authorizations do not apply to any other menthol-flavored e-cigarette products,” the FDA stated. Publicly traded companies in the tobacco products space include Altria Group (MO), British American Tobacco (BTI), Imperial Brands (IMBBY) and Philip Morris (PM).

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