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The agency greenlit 4 Glas electronic nicotine delivery systems through the premarket tobacco product application pathway, a historic first that comes amid reported White House pressure on FDA Commissioner Marty Makary.
The FDA has authorized the marketing of 4 Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application (PMTA) pathway, the agency announced on May 5, 2026, marking the first time it has authorized nontobacco, nonmenthol flavored vaping products for sale in the US.1,2
The authorized products are e-liquid pods, each containing 50 mg/mL (5%) of tobacco-derived nicotine, marketed under the names Classic Menthol, Fresh Menthol, Gold, and Sapphire. Gold and Sapphire correspond to mango and blueberry flavors, respectively, according to the FDA release.1,2
The authorization came the same day The Wall Street Journal reported that President Donald J. Trump rebuked FDA Commissioner Marty Makary, MD, MPH, for not moving quickly enough to approve flavored vapes and nicotine products. Earlier this year, The Wall Street Journal reported that Makary was opposing the authorization of the 4 Glas products after FDA scientific advisers had authorized them. Now, the company has been authorized to legally market its products to users 21 years or older.3,4