PMTA Deadline Raises Store-Level Uncertainty

Retailers at CRU express concern as FDA’s tobacco product application process advances
Tobacco CRU
Photograph by W. Scott Mitchell

NEW ORLEANS — With the deadline for manufacturers to submit their premarket tobacco applications (PMTAs) to the U.S. Food and Drug Administration (FDA) looming, retailers on a panel at CSP’s recent Convenience Retailing University (CRU) conference expressed concerns over how to handle products moving forward.

The FDA’s new-product review process will leave many unanswered questions around what products retailers can continue to carry, said Kraig Knudsen, category manager for Circle K’s Heartland division, Lisle, Ill. Explaining his expectations to about 50 attendees in a tobacco breakout session, he said that as of the May 12, 2020, deadline, the FDA will receive a flood of very complicated applications, many of which will be “thousands” of pages. “The science has to be reviewed, validated and verified,” he said. “It’s a huge undertaking.”

While most of his manufacturing partners have told him they are submitting applications, Knudsen said retailers won’t actually know whether suppliers have submitted PMTAs for their full portfolio or if they will be “cherry-picking SKUs” based on return on investment.

If manufacturers decide not to submit PMTAs for certain products, will they tell retailers? And if they do, will retailers take products off shelves once that May 12 deadline passes? In the real world, some might, some won’t, Knudsen said.

“We don’t want to be in direct noncompliance,” Knudsen said. “But my biggest question is enforcement: How is that going to be policed?”

And if the FDA denies an application and a product has to be removed, Knudsen asked, “What’s the timeline? Sixty days? Eighty? And who will cover the cost? I haven’t heard that information.”

Still, despite the confusion, Knudsen is grateful that innovative products such as vaping devices and nicotine pouches have arrived on the scene.

Kole Olinger, category manager for Jacksons Food Stores, Meridian, Idaho, agreed, saying that while staying on top of regulations is his top priority, managing the evolving nicotine segment is just as important.“The nicotine pool is a huge segment that’s not necessarily shrinking,” he said. “It’s the method of delivery [that’s changing].”

In terms of his strategy going forward, Olinger said, “It’s figuring out market dynamics, customer demographics, what works here, what works there … what’s going to be successful and marrying that with your store strategy.”

Next year’s Convenience Retailing University will be held Feb. 23-24, 2021, in Orlando, Fla. Click here for more information.

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