Senate Democrats Decry FDA Extension of 'Deeming Rule' Deadline for E-Cigarettes
Thirteen Senate Democrats in an Aug. 4 letter to FDA Commissioner Scott Gottlieb expressed displeasure about his agency’s decision to delay by five years the implementation of rules that will deem e-cigarettes, cigars and pipe tobacco subject to FDA’s tobacco regulations. The “deeming rule” was originally set to take effect on May 10, before the FDA delayed the deadline by three months (see 1705120035). Under revised timelines announced July 28, the FDA will accept applications for newly regulated combustible products like cigars, pipe tobacco and hookah tobacco through Aug. 8, 2021, as well as applications for non-combustible products such as “electronic nicotine delivery systems” and e-cigarettes through Aug. 8, 2022.
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“There is no reason for the Agency to delay oversight of newly-regulated tobacco products, including electronic cigarettes (e-cigarettes) and cigars that contain kid-appealing flavors and are actively marketed to children,” says the letter led by Senate Minority Whip Dick Durbin of Illinois and Sens. Patty Murray of Washington and Jeff Merkley of Oregon. The senators commended the FDA for parts of the new tobacco plan that could lead to reduced nicotine in cigarettes, but also complained about the “potentially prolonged timeframe” to implement such measures. The letter says that postponing the “deeming rule” is an abandonment of FDA’s duty to safeguard public health, citing a 2016 Surgeon General report that found e-cigarettes are marketed by promoting flavors that appeal to children, including candy and fruit flavorings, leading to greater use among kids and teens. The senators pushed Gottlieb to develop a plan to reduce nicotine in cigarettes quickly, including soon issuing an advance notice of proposed rulemaking and setting a time frame for completion of a final rule.