FDA Plans to Defer PMTA Enforcement for Some Cigars; Not Vapes

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.

“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

— American Vaping Assn (@AVABoard) August 6, 2020

The agency also says a large number of PMTA submissions by cigar manufacturers would prevent the regulators from focusing on review of vaping product applications.

“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 agency says. “The forthcoming guidance will allow the FDA to focus its limited enforcement resources on premarket applications for other types of deemed products posing greater risk for youth initiation or use (of which the FDA anticipates receiving a significant volume by the September 9, 2020 deadline).”

The Sept. 9 deadline was originally set for May 12. It was postponed by the FDA, with permission from Judge Grimm, because of challenges to PMTA filers and the agency caused by the coronavirus pandemic.

Yesterday’s letter may indicate that the agency does not intend to ask Judge Grimm for another delay of the submission deadline. Many small vaping manufacturers have requested a second delay, because of limited access to laboratories,shipping delays, and travel restrictions created by the pandemic. While it remains possible that the FDA will request another postponement of the deadline, it seems likely that the agency would have done that before proposing major changes to guidance for manufacturers.

The letter also suggests that the agency will use its enforcement discretion to pursue vaping manufacturers almost exclusively, and ignore combustible tobacco products. The FDA clearly is not planning to offer open-system vaping manufacturers an opportunity to request enforcement delays—even if they can prove that adolescents are not interested in their products.

FDA may be finally recognizing that the PMTA process is too complicated and costly for small businesses with hundreds or thousands of SKUs ... So long as your small business makes premium cigars and not vaping products. pic.twitter.com/0saNJDbG6W

— Gregory Conley (@GregTHR) August 6, 2020

The FDA must get permission from Judge Grimm for any changes to PMTA enforcement because Grimm ruled against the agency last year in a lawsuit brought by a group of anti-vaping organizations, led by the American Academy of Pediatrics. The plaintiffs had challenged the FDA’s 2017 postponement of the PMTA deadline until 2022 based on administrative requirements. Grimm set the new deadline, and a federal appeals court upheld the decision earlier this year.

The anti-tobacco plaintiffs oppose the FDA’s plan to exempt premium cigar manufacturers from PMTA enforcement, according to the letter from the agency, and will respond to the judge themselves by Aug. 17.

The plaintiffs, which include the Campaign for Tobacco-Free Kids, probably fear any chink in the PMTA wall. Although premium cigars are not widely used by youth, allowing enforcement exemptions for one product might lead to concessions for others. A favorable ruling on premium cigar enforcement might even lead to lawsuits by vaping manufacturers challenging the FDA’s decision to exclude their products from deferral.

After all, if vaping manufacturers can show that their products are not popular with and have never been sold to teenagers, why should they be prioritized for enforcement over actual combustible tobacco products?

Meanwhile, the most dangerous tobacco product of all—combustible cigarettes—is safe from enforcement: grandfathered onto the market, and available in every convenience store and gas station in the country. Unlike vaping products, cigarettes are not required to prove that they are “appropriate for the protection of public health.”

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Article Author: Jim McDonald