Litigation Stifles FDA Efforts

Graphic warnings on cigarette packages, shifting PMTA deadlines create confusion, NATO says
Photograph by CSP Staff

BROOMFIELD, Colo. — Litigation and the questionable lawfulness of recent U.S. Food and Drug Administration (FDA) efforts—ranging from graphic warning labels to new-product application deadlines—have created confusion for tobacco manufacturers and retailers, said an official with tobacco retailing association NATO at a recent conference.

Speaking at a special seminar affiliated with the 23rd annual Smoker Friendly conference and tobacco festival in Broomfield, Colo., Tom Briant, executive director of Lakeville, Minn.-based NATO, said litigation can often lead to uncertainty. In the case of the deadlines for premarket tobacco applications (PMTAs), the FDA has changed the deadline five times in recent years due in part to litigation.

The most recent deadline for manufacturers to submit PMTAs is May 11, 2020, but a new lawsuit is asking a federal court to move that deadline yet again. In that lawsuit filed Aug. 14, the Vapor Technology Association (VTA), Washington, D.C., alleges that the FDA set the May 2020 deadline in response to a federal court’s direction that did not involve proposing the new deadline through the required rulemaking process under the law.

“The VTA asked the court to let the FDA file a new guidance to fully explain what needs to be included in a completed PMTA application, as the current guidance did not provide all the information needed,” Briant said at the Aug. 22 seminar. “Let the FDA finish its guidance document, then change the May 2020 deadline to a reasonable date in future. Otherwise the deadline will be here and products will have to come off the market.”

In a related matter, Briant said the FDA’s recently produced draft guidance on graphic warning labels may see challenges in the courts because the FDA’s first set of graphic cigarette health warnings proposed in 2010 were struck down as a result of a manufacturer lawsuit. The newly proposed warning labels mirror European paradigms, visually depicting the illnesses that can result from habitual tobacco use.

Before an audience of about 400 tobacco suppliers and retailers, Briant also talked about local and state efforts to regulate tobacco, ranging from raising the minimum age to purchase products from the federal standard of 18 to 21 to banning flavored products. He suggested retailers be preemptive by reaching out to lawmakers and helping them understand the effect such measures would have on their businesses.

“Invite the city councilman to your store and explain your business model,” Briant said. “Build a relationship beforehand and they’ll remember how it will impact your store.”

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