March 28, 2018

Providers, public health groups sue FDA for delaying new e-cig regs

Daily Briefing

    Several pediatricians and medical and public health groups on Tuesday filed a lawsuit against FDA over the agency's decision to delay implementation of a final rule that requires electronic cigarette manufacturers to submit their products to the agency for review, Reuters reports.

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    The lawsuit comes amid FDA's recent push to review its tobacco regulations as part of the agency's comprehensive plan to reduce tobacco-related disease and deaths. FDA in recent weeks has issued three separate advance notices of proposed rulemaking related to tobacco flavors, nicotine levels in cigarettes, and regulations regarding so-called "premium" cigars.

    Lawsuit details

    The lawsuit focuses on 2017 guidance that delayed the effective date of a provisions within the final rule that required e-cigarette and cigar producers to submit their products for regulatory review. Both provisions were set to take effect August 2018, but the 2017 guidance delayed the effective date until August 2022 for e-cigarette producers, and August 2021 for cigar producers.

    The plaintiffs in the lawsuit claim FDA exceeded its authority under the Family Smoking Prevention and Tobacco Control Act and violated federal law when it issued the 2017 guidance delaying the provisions' implementation. The lawsuit states, "FDA has no legal authority to absolve regulated entities of their legal obligation to comply with statutory mandates in that manner."

    The lawsuits alleges that FDA violated the Administrative Procedure Act because it issued the guidance without providing the public an opportunity to comment on the agency's decision to delay the provisions. Further, the lawsuit claims that FDA "fundamentally altered the statutory duties and responsibilities of manufacturers of newly deemed tobacco products" and "offered no meaningful justification for ripping a hole in the statutory framework."

    According to the lawsuit, FDA's decision to delay the final rule allows tobacco products that target teenagers and children, such as e-cigarettes, to stay on the market for several years without undergoing a regulatory review, posing a threat to their health. "Consumers will continue to be exposed for many years to thousands of tobacco products containing lethal and addictive components that have not met the statutory requirements," the lawsuit claims. The plaintiffs, which filed the lawsuit in the U.S. District Court for the District of Maryland, include five pediatricians, as well as the:

    • American Academy of Pediatrics, as well as the academy's Maryland chapter;
    • American Cancer Society Cancer Action Network;
    • American Heart Association;
    • American Lung Association (ALA);
    • Campaign for Tobacco-Free Kids; and
    • Truth Initiative.


    Erika Sward, assistant vice president of national advocacy at ALA, said filing a lawsuit "was the only remedy [ALA] thought [it] could take." Sward noted that use of nicotine products—such as e-cigarettes and cigars—among teens increased to 20.2%, while cigarette use declined to 8%.

    FDA declined to comment on the lawsuit, according to Reuters. However, FDA Commissioner Scott Gottlieb in a tweet Tuesday wrote that FDA "shares the belief that tobacco products, including e-cigs, should never be marketed to, sold to, or used by kids and the agency will be taking new steps soon to help keep kids from using tobacco products" (Raymond/Mincer, Reuters, 3/27; Perrone, AP/Sacramento Bee, 3/27; Drage O'Reilly, Axios, 3/28; McGinley, "To Your Health," Washington Post, 3/27; Wheeler, The Hill, 3/27; Gottlieb tweet, 3/27).

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