In a recent letter to U.S. District Court Judge Paul Grimm, the FDA has requested permission to defer PMTA enforcement against manufacturers of premium cigars rather than vaping products. September 9 is the deadline to submit Premarket Tobacco Applications for all deemed tobacco products, including cigars and vapor products. This letter dated August 5 and was signed by the Department of Justice attorneys working on behalf of the FDA.
In this letter, it states:
"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."
"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 claims the deferrals are necessary to preserve scarce agency resources and more effective enforcement against the most significant target, which points to flavored e-cigarettes.
"The FDA's top priority for premarket review of deemed products remains products that pose the greatest risk for initiation or use by underage persons, such as flavored, cartridge-based e-cigarette products targeted to or easily accessible to youth. Because the FDA's current information indicates that youth smoke premium cigars comparatively less than most other deemed tobacco products, like e-cigarettes, premium cigars remain the FDA's lowest priority for premarket review."
"Open systems — the products used least by youth but most at risk of being banned by the FDA — will continue to be sold, but in new illicit markets with limited or no safety controls instead of in regulated vape shops."#pmtareform https://t.co/lDpgjaGfwp
Moreover, the agency said:
"At the same time, premium cigars are made in many varieties with thousands of stock units, which could entail a large influx of premarket applications for premium cigars on the market as of the deeming rule's effective date."
"The forthcoming guidance will allow the FDA to focus its limited enforcement resources on premarket applications for other types of deemed products posing a greater risk for youth initiation or use (of which the FDA anticipates receiving a significant volume by the September 9, 2020 deadline)."
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