SILVER SPRING, Md. — It has been nearly a year since the Sept. 9 deadline for companies to submit their premarket tobacco product applications (PMTAs) for deemed new tobacco products to the U.S. Food and Drug Administration (FDA).
As of Sept. 1, Philip Morris Products S.A.’s IQOS System holder and charger is the only product in the last year to have received a marketing order, according to the FDA’s website that tracks this information.
That could change soon, though.
“The FDA is working to review as many of the applications by Sept. 9, 2021, as possible,” an FDA spokesperson said in an Aug. 30 statement to CSP. “In general, the court gave the FDA until Sept. 9, 2021, to complete review of the applications; however, given the unprecedented number of applications, the size, complexity and diversity of the submissions and the finite nature of our review resources, among other factors, the likelihood of FDA reviewing all the applications by Sept. 9, 2021, will be challenging. We will continue to allocate our resources with the goal of working as quickly as possible to transition the current marketplace for deemed products to one in which all products available for sale have undergone a careful, science-based review by FDA.”
The FDA’s Center for Tobacco Products Director Mitch Zeller had previously told CSP that after the Sept. 9, 2021, deadline the agency can on a case-by-case basis decide to extend enforcement discretion for those products.
The FDA has already made some decisions on what products it will not authorize. It asked e-liquid company JD Nova Group LLC to remove about 4.5 million products because its PMTAs did not meeting filing requirements. Shortly after, the FDA announced marketing denial orders (MDOs) for about 55,000 flavored electronic nicotine delivery systems (ENDS) products, meaning they have to go off the market, too.
If products are not authorized by Sept. 9, and do not come off the market at that time, they risk FDA enforcement, the agency told CSP. If the FDA takes a negative action, like the issuance of an MDO, on an application prior to Sept. 9, the product must be removed from the market.
What to expect Sept. 9
There is some confusion among suppliers and convenience-store retailers on what to expect leading up to Sept. 9.
One c-store retailer, who asked to remain anonymous, told CSP he is expecting to hear “a whole lot of nothing” from the FDA regarding PMTAs before Sept. 9. He thinks the FDA will ask the U.S. District Court for the District of Maryland, which set the deadline for filing submissions, for an extension on reviews.
If no marketing orders are released by Sept. 9, the retailer plans to keep tobacco products for which PMTAs were submitted on time on the back bar—unless the FDA gives other guidance before then. While he hopes alternative tobacco products to help smokers switch from combustible cigarettes will remain on the market, if a product must be pulled, he hopes there will at least be a sell-through period.
Retailers should know the world doesn’t end on Sept. 9, one e-cigarette maker told CSP.
“I don’t think that Sept. 9 is necessarily a death knell for the industry, even if market orders haven’t been issued across the board,” Chris Howard, vice president, general counsel and chief compliance officer at E-Alternative Solutions (EAS), Darien, Conn., said on Wednesday. “But I can recognize that people are uncertain about this, and they want more information. I think that we have to give FDA the benefit of the doubt here. I think there’s more news to come between now and a week from now.”
Howard said that because the FDA has some enforcement discretion after the deadline, EAS does not plan on removing its products from the market if they haven’t heard an update on the status of their PMTA by Sept. 9.
EAS submitted PMTAs for several flavors and strengths of its Leap and Leap Go vapor products. The company’s applications made it to the scientific review state and received a deficiency letter from the FDA, to which EAS responded. After that, the FDA indicated it had accepted EAS’s response to the letter and said it would get back to them in 90 days, Howard said.
“That 90 days has passed, so we know that FDA is still working on it,” he said. “We do not intend to remove our products from the market on the Sept. 10. Hopefully the FDA will make that more clear.”
Retailers looking for more clarity should ask responsible manufactures in the industry about the status of their applications, Howard said, and check the FDA’s list to make sure its tobacco supplier’s applications were turned in on time. Those applications filed by Sept. 9, 2020, include more than 6 million tobacco products, the FDA has said.
Juul’s take
E-cigarette manufacturer Juul—the company that has, perhaps, faced the most backlash for what the U.S. Surgeon General called a youth vaping epidemic—said it would be inappropriate of the company to speculate on what the FDA is going to decide.
It believes it has presented compelling evidence, though, about its products’ abilities to convert smokers and its data-driven measures to combat underage use, a spokesperson for the San Francisco-based company told CSP.
“While millions of adult smokers have converted to our products from cigarettes, we will only be trusted to provide alternatives to adult smokers if we continue to combat underage use, respect the central role of our regulator and build on our shared commitment to science and evidence,” the spokesperson said.