FDA Marketing Application Deadline Passes: What Happens Now?

    FDA Marketing Application Deadline Passes: What Happens Now?

    Sept. 9, 2020, was the U.S. Food and Drug Administration’s (FDA) deadline for manufacturers to submit either a substantial equivalence (SE) report or a premarket tobacco product application (PMTA) for “deemed” tobacco products that were introduced into the marketplace between Feb. 15, 2007, and Aug. 8, 2016. Tobacco products subject to the PMTA requirements include cigars (with the exception of “premium cigars” as noted below), pipe tobaccos, electronic cigarettes, nicotine vapor products, hookah tobacco, alternative nicotine products and heated nicotine products.

    Many brands of domestic cigars, pipe tobaccos and hookah tobacco products were already on the market as of Feb. 15, 2007, therefore they qualify for grandfather status and do not need an SE or PMTA to remain on the market. For those domestic cigars, pipe tobacco and hookah tobacco products that are not grandfathered, manufacturers must have filed either an SE or PMTA application with the FDA by Sept. 9, 2020.

    Because there were no electronic cigarette, vapor or alternative nicotine products on the market as of Feb. 15, 2007, they will not be grandfathered, and there is generally no substantially similar product to rely on to file an SE application. For these products, manufacturers were required to file PMTAs with the FDA by Sept. 9 or their products could no longer be sold to the public.

    As “premium cigars” only, a federal court ruling issued in August of this year deferred enforcement of the FDA’s Sept. 9 application filing deadline, preventing the FDA from enforcing the application requirement against premium cigars until the agency creates a streamlined SE application process for them. “Premium cigars” are defined as a cigar that: (1) is wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) contains at least 50 percent (of the filler by weight) long-filler tobacco (i.e., whole tobacco leaves that run the length of the cigar); (4) is handmade or hand-rolled (i.e., no machinery was used apart from simple tools, such as scissors, to cut the tobacco prior to rolling); (5) has no filter, nontobacco tip or nontobacco mouthpiece; (6) does not have a characterizing flavor other than tobacco; (7) contains only tobacco, water and vegetable gum, with no other ingredients or additives; and (8) weighs more than six pounds per 1,000 units.
    Once a manufacturer files an SE or PMTA with the FDA, the agency follows a five-step process.

    First, the FDA conducts a preliminary review of an application to see if everything is complete. If so, the FDA issues a letter accepting the application. Second, the agency files the application if all of the scientific studies, evidence and other data are complete. Third, the FDA undertakes its substantive review of the application and supporting documentation and studies, which can take up to one year. Fourth, the FDA issues an order either approving or not approving the application. In order to approve an application, the FDA needs to determine that the product “is appropriate for the protection of the public health.” This is the standard set down by Congress to determine whether a tobacco product is approved for marketing in the United States. Lastly, the FDA publicizes the approval order or non-approval order.