In a letter to U.S. District Court Judge Paul Grimm, the FDA has requested permission to defer PMTA enforcement against manufacturers of premium cigars—but not vaping products.
The deadline to submit Premarket Tobacco Applications for all deemed tobacco products (including cigars and all vapor products) is Sept.9. The letter, dated Aug. 5, was signed by Department of Justice attorneys working on behalf of the FDA.
Because the judge had granted the FDA the ability to exempt products from the application requirements on a case-by-case basis, the agency is now proposing that individual cigar manufacturers be allowed to submit requests for deferral.
“The FDA intends to exercise its retained discretion by deferring enforcement of the premarket authorization requirement for premium cigar manufacturers and importers on a case-by-case basis,” says the letter. “The deferrals are intended to help prioritize the use of the FDA’s limited enforcement resources while the agency undertakes a new research effort to evaluate the public health impact of premium cigars. The FDA intends to describe how manufacturers and importers can submit deferral requests in a guidance document that would take effect immediately upon issuance.”
The FDA says the deferrals are necessary to preserve scarce agency resources for more effective enforcement against the most important target: flavored e-cigarettes.
Jim McDonald – Vaping360 – August 6, 2020.
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