Seven health and medical groups filed suit against the FDA for its extension of new-product application deadlines for ENDS and cigars, according to one of the groups filing the suit.
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,” or SE, report (saying a product was essentially the same as a something already on the market) or one for brand-new products, 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. Instead of Feb. 8, 2018, for SE reports and Aug. 8, 2018, for PMTAs, the FDA revised application deadlines for all combustible products to Aug. 8, 2021, and Aug. 8, 2022, for noncombustible products, according to the filing.
The original deadlines were part of the FDA’s so-called “deeming” rule, implemented in August 2016. Soon after the fall 2016 elections, Gottlieb, took charge of the FDA and in July 2017 announced the deadline extensions. The FDA has also said that these products will remain on the market indefinitely during the review process and did not set a deadline for completing its review, according to the Washington, D.C.-based Campaign for Tobacco-Free Kids.
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 said.
In addition to the Campaign for Tobacco-Free Kids, plaintiffs include 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.