Federal Court Rules on FDA Product Application Deadlines

NATO NEWS

Federal Court Rules on FDA Product Application Deadlines

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Both the FDA and the industry find themselves in a tough spot at the hand of a Federal court, which overruled delayed deadlines for new product applications and sped up the process.

>BY THOMAS BRIANT

On July 12th, U.S. District Court Judge Paul Grimm issued a decision in favor of a coalition of public health groups that will require makers and importers of electronic cigarettes—and certain other tobacco products like cigars and pipe tobacco—to submit product applications to the FDA’s Center for Tobacco Products within ten months. In response, acting FDA Commissioner Ned Sharpless announced that FDA stood ready to accelerate the review of these new tobacco product applications.

Under the revised application timetable, Pre-Market Tobacco Authorization (PMTA) submissions for electronic cigarettes and Substantial Equivalence (SE) applications for cigars and pipe tobacco products must both be filed with the FDA by May 11, 2020 in order for products currently on the market to remain on the market pending review. Three major cigar industry associations – the Cigar Association of America, the Premium Cigar Association, and the Cigar Rights of America – fought to maintain the original extended deadlines as previously adjusted by the FDA.

In August 2016, the FDA expanded the reach of the Family Smoking Prevention and Tobacco Control Act (the Act) to include cigars, pipe tobacco, electronic cigarettes, hookah tobacco and dissolvable tobacco products. Under the Act, any newly deemed tobacco product that was not on the market as of February 15, 2007 or for which a SE or PMTA application had not been filed and approved by the FDA since the February 15, 2007 date, was technically not compliant to sell in the U.S.

In the initial deeming rule in 2016, the FDA provided 12-month, 18-month or 24-month time periods within which companies could file SE or PMTAs for the new products. In 2017, then-FDA Commissioner Scott Gottlieb extended the product application deadlines twice, ultimately to August 2021 for combustible tobacco (cigars, pipe tobacco and hookah) and to August 2022 for non-combustible products (electronic cigarettes). This extension allowed the manufacturers to keep their newly deemed products on the market while SE or PMTA applications were compiled.

A coalition of tobacco control and public health organizations (the American Academy of Pediatrics, the Maryland Chapter of the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco Free Kids, the Truth Initiative and several doctors) challenged the FDA’s deadline extensions in federal court in March 2018, claiming the deadline extensions exceeded the authority granted to the FDA under the Tobacco Control Act. Judge Grimm ruled in favor of the plaintiffs and ultimately ordered the deadlines moved up.

In responding to the Court and proposing remedies, the coalition of health and tobacco control groups pushed for a deadline shorter than the 120 days issued by the Court, but have largely supported the decision to move up the deadlines and the Court specifically mandating that application review from the FDA be completed within a year following submissions.

Despite deeming cigars, pipe tobacco, hookah and electronic cigarettes as tobacco products within the jurisdiction of the Tobacco Control Act in 2016, it was not until earlier this year that the FDA issued a proposed final guidance on market application deadlines. NATO submitted public comments with concerns about the proposed guidance and its ambiguities and impacts on retailers of combustible and non-combustible tobacco products. The guidance has yet to be finalized. With a considerable number of registrations for new vapor products and a likely significant number of PMTA and SE applications to consider for cigars and pipe tobacco, it remains to be seen how FDA might expedite its process to meet the deadlines set by Judge Grimm.

Thomas Briant is executive director of the National Association of Tobacco Outlets (NATO), Toll-free: (866) 869-8888, Web: www.natocentral.org.