FDA Fails to Meet Deadline to Decide on PMTA Applications for Vapes

September 9, 2021

The day of reckoning will have to come another day.

On September 9, its longstanding deadline, the Food and Drug Administration (FDA) effectively announced that it would need more time to process the remaining premarket tobacco product applications (PMTAs) that vape companies were required to file last year to stay legally on the market. Approval would mean that products were deemed “appropriate for the protection of public health”—a potential game-changer for tobacco harm reduction in the United States.

The agency did not mention how much longer it planned to take—nor did it officially state that it was essentially giving itself an extension. In a perspective hyperlinked to a press release, though, it did state that decisions would be made on a “rolling basis.” Hundreds of thousands of PMTAs, at least—including all of those submitted by the largest vape manufacturers—are left.

We continue to work expeditiously.”

Despite this admission, the FDA did assure everybody that “significant progress” had been made, referencing its “taking action” on 93 percent of the PMTAs as well as its issuing of 132 marketing denial orders (MDOs), requiring the affected companies to immediately stop selling their products. No authorizations have so far been issued.

We continue to work expeditiously on the remaining applications that were submitted by the court’s September 9, 2020, deadline, many of which are in the final stages of review, Janet Woodcock, the acting FDA commissioner, and Mitch Zeller, the director of the FDA’s Center for Tobacco Products, said in a joint statement.

For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard.

As usual, with the FDA’s unwavering commitment to ambiguity, we are left to parse what exactly the agency means. The press release appears to imply that vaping companies with pending applications are not an enforcement priority for the agency, while those that have been sent MDOs are.

We remain stuck on the same page of a book public health officials seem incapable of flipping.

The date of September 9, 2021 had been, if not welcomed, also not completely feared by vaping advocates. Many believed that any FDA authorization would signal a broad acceptance of harm reduction and the potential for society to embrace safer nicotine alternatives.

Consequently, it was a frustrating, disappointing and anticlimactic afternoon, as anxious observers waited around for hours, on a day the FDA had long known was coming, only to be told that no decision had been reached. (“BIG NOTHING!!!” an industry insider texted me.) We remain stuck on the same page of a book public health officials seem incapable of flipping: On the one hand, tobacco harm reduction (THR) proponents keep clamoring that vaping is significantly safer than smoking; on the other, prohibition-minded organizations call for more bans.

Eyes will now be on many of those anti-nicotine groups, which previously sued the FDA and cemented the PMTA deadline that the agency just blew past. The legality of the FDA’s latest move remains an open question: After a court ruling in July 2019, and subsequent COVID-related delay, the FDA was legally supposed to make decisions by September 9. Vaping companies had until last September to submit their PMTAs, an onerous and expensive procedure that required substantial scientific and behavioral studies that would determine if each product, on a case by case basis, was authorized.

Though the FDA’s interpretation of “appropriate for the protection of public health” has been hazy, it has recently become evident that the agency is determining if each product is more likely to transition adult smokers off combustible cigarettes than it is to initiate youth to lifetime nicotine use. Many FDA critics have started to argue this may have been the plan all along: Because the rulemaking process requires quite a bit of oversight, the agency has slowly revised authorization standards at the last minute to favor a select number of players, and is hoping to avoid legal action.

While the agency had repeatedly signaled that it would not be able to review all the PMTAs in time, it did clarify that the focus would be on finishing those submitted by the major players. That was largely understood to encompass the so-called Big Five: Juul, Vuse (owned by RJ Reynolds Vapor Company, a subsidiary of Reynolds American), NJOY, Blu (owned by Imperial) and Logic. But the FDA has not been able to accomplish even that.

Regardless, worries abound among vape shop owners, smaller manufacturers and consumer advocates that, sooner or later, the government will hand the industry over to well financed producers—several of which are owned by, or have financial links to, Big Tobacco.

This self-imposed extension, while disappointing, is not necessarily a surprise: It took years, for example, for the FDA to authorize a marketing order for Philip Morris’s IQOS—a heat-not-burn product (HTP) that has taken off in countries like Japan, rapidly driving down smoking rates. The FDA now permits the marketing of IQOS as a “modified risk product” that “significantly reduces the production of harmful and potentially harmful chemicals” compared with smoking.

Plus, on the surface, it did appear as if the FDA was busy this past month, as mainstream publications checked their calendars and started to write about the reshaping of an industry that has been castigated into disarray for years: first, through headlines of a youth vaping “epidemic” that has, if it ever really existed, subsided; and second, through the botched handling of“EVALI”—the string of “vaping-related” illnesses that the Centers for Disease Control and Prevention (CDC) only belatedly acknowledged came from illicit, adulterated THC cartridges, not nicotine vapes.

Both those panics led to draconian policies intended to steer youth away from e-cigarettes, but more and more evidence is mounting that flavor bans have had a dangerous effect: They have, reputable studies show, driven teens to smoking.

“This decision brings even more uncertainty on the day FDA had previously pledged to provide the public with answers.

In early August, the FDA refused to file some 4.5 million PMTA applications from a single company, JD Nova, stating that the manufacturer had failed to provide an adequate Environmental Assessment (EA) for each of those submissions. The omission was something of a bureaucratic error, in that JD Nova did not seem to understand it needed to provide not only an EA for each flavor it makes, but for each variation of that flavor—for separate nicotine levels and bottle sizes, many of which were not even available for purchase.

But the decision gave the FDA the appearance of having boldly wiped out 4.5 million of the 6 million or so PMTA applications—about 75 percent—in one fell swoop.

Later in August, the FDA began to outright deny hundreds of thousands of PMTA applications, and manufacturers immediately sought to explore regulatory loopholes like synthetic nicotine, a legal gray area.

America’s tobacco and nicotine regulatory system is broken beyond repair,” Greg Conley, the president of the American Vaping Association, told Filter. It is absolutely absurd that the same agency that found time to ban over 6 million vaping products manufactured by small businesses is now indicating they need more time to review products with massive market shares. Even worse, after spending five-plus years peddling false hope to businesses across America, the FDA now cannot even be bothered to grant formal extensions to the remaining pending applicants. This decision brings even more uncertainty on the day FDA had previously pledged to provide the public with answers.

If smoking rates go up in 2022 and beyond, do not blame the tobacco industry, he continued. This predictable result will entirely be the fault of elected officials and regulators who have utterly failed to protect public health.

 


 

Photograph by the CDC via Unsplash

The Influence Foundation, which operates Filter, has received unrestricted grants and donations from Juul, Reynolds American, Philip Morris International and the American Vaping Association. Filter’s Editorial Independence Policy applies.

Alex Norcia

Alex is a staff writer at Filter. He previously worked as a reporter and copy editor at VICE, and has been published in The New York Times MagazineThe Columbia Journalism ReviewThe Nation and The Daily Beast, among other outlets. He was also previously a freelance editorial consultant for the Foundation for a Smoke-Free World; The Influence Foundation, which operates Filter, has received grants from the Foundation for a Smoke-Free World. Alex is currently based in Los Angeles.

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