SILVER SPRING, Md. -- Seven health and medical groups have filed a lawsuit against the U.S. Food and Drug Administration (FDA), targeting the agency’s extension of new-product application deadlines for electronic nicotine delivery systems (ENDS) and cigars.
Filed in a federal court in Maryland on March 27, the lawsuit targets the FDA’s extension of 2018 deadlines for manufacturers of new nicotine-delivery products to submit either a substantial equivalency (SE) report saying a product was essentially the same as a something already on the market or a separate report for brand-new product types, called a premarket tobacco application (PMTA). Once received, the FDA would review the submissions to decide whether to allow manufacturers to market and sell those products in the United States. Initially, the FDA set filing deadlines of Feb. 8, 2018, for SE reports and Aug. 8, 2018, for PMTAs. However, in July 2017, the FDA revised the application deadlines for all combustible products to Aug. 8, 2021, and to Aug. 8, 2022, for noncombustible products,
The original deadlines were part of the FDA’s so-called “deeming rule,” implemented in August 2016. Soon after the fall 2016 elections, however, a new commissioner, Dr. Scott Gottlieb, took charge of the FDA and announced the deadline extensions. The Silver Spring, Md.-based FDA also said that these products can remain on the market indefinitely during the review process and did not set a deadline for completing its review, according to the complant.
The lawsuit alleges that the FDA’s extension of the product-review deadlines exceeds the agency’s authority under the Family Smoking Prevention and Tobacco Control Act, the 2009 law that established FDA oversight of tobacco products. It also alleges that the FDA’s decision violates the Administrative Procedure Act because the FDA did not give the public an opportunity to comment on the change and did not articulate an adequate, factual basis for the change from the deadlines the FDA itself established in the deeming rule.
The FDA “offered no meaningful justification for ripping a hole in the statutory framework by exempting, for more than half a decade, newly deemed products from premarket review—review the FDA previously described as ‘central’ to the regulatory scheme Congress enacted for tobacco products,” the lawsuit says.
Plaintiffs in the lawsuit include the Washington, D.C.-based Campaign for Tobacco-Free Kids; the American Academy of Pediatrics, Itasca, Ill., and its Maryland chapter; American Cancer Society Cancer Action Network, Washington, D.C.; American Heart Association, Dallas; American Lung Association, Washington, D.C.; Truth Initiative, Washington, D.C.; and five individual pediatricians.