Docket No. FDA-2013-S-0610

Dear Secretary Azar and Commissioner Hahn:

On behalf of the small vapor product manufacturers, retailers, and trade associations listed below (“Petitioners”), as well as similarly situated businesses, the undersigned submit this citizen petition under 21 C.F.R. § 10.30 and the Family Smoking Prevention and Tobacco Control Act (“TCA”). Petitioners request that the Food and Drug Administration (“FDA”) seek, pursuant to Fed. R. Civ. P. 60(b), a 180-day extension of the September 9, 2020 deadline for filing Premarket Tobacco Product Applications (“PMTA”), which was set by the United States District Court for the District of Maryland, due to the on-going COVID-19 pandemic. Small manufacturers continue to experience significant delays caused by the coronavirus outbreak in their efforts to complete and file timely PMTAs by the current deadline. These businesses will likely not be able to file compliant applications by the cutoff, and thus could be forced to lay-off thousands of employees and close their doors permanently if the extension is not granted.

See FDA Docket here.

See PDF of Petition here.

Keller and Heckman LLP – Food and Drug Administration – August 24, 2020.

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