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October 19, 2021

PMTA News: FDA Authorizes Zombie Nicotine Product

The FDA today added a nicotine chew to its short list of authorized consumer nicotine products. It becomes the second product authorized in the last seven days, after RJ Reynolds’ Vuse Solo earned a go-ahead last week.

The agency has granted marketing authorization to four variations of Altria’s VERVE—a small three-sided oral product coated with nicotine. The FDA gave the green light to both a soft version (Chews) and a hard one (Discs), each in two mint flavors, and all four containing just 1.5 milligrams of nicotine.

The only problem for consumers is that VERVE was removed from the market in December 2018, at the same time the company shut down its MarkTen and Green Smoke e-cigarette brands. (Exactly two weeks later, Altria announced it was buying a 35 percent share in Juul Labs.)

After submitting Premarket Tobacco Applications (PMTAs) for VERVE in July 2018, Altria subsidiary U.S. Smokeless Tobacco Company continued the back-and-forth process with the FDA even after removing VERVE from the market.

According to the FDA’s “decision summary,” Altria’s PMTA for VERVE did not include any “product-specific” evidence about its risk as a flavored product to youth. Rather, the PMTA used data bridged from previous studies and surveys on other oral products—something the agency now says is not acceptable for flavored vaping products.

It’s not known if this lower bar will apply to other modern oral products like nicotine pouches and lozenges. Altria submitted PMTAs, including more than 66,000 pages of documentation, for all of its On! nicotine pouches—and other manufacturers also have pending PMTAs for flavored pouches and other oral products.

“While these are mint-flavored products, data submitted to the FDA show the risk for youth uptake of these particular products is low, and stringent marketing restrictions will help prevent youth exposure,” FDA Center for Tobacco Products Director Mitch Zeller said in a statement. “Importantly, evidence shows these products could help addicted smokers who use the most harmful combusted products completely switch to a product with potentially fewer harmful chemicals.”

It’s questionable whether “addicted smokers” would get any relief from an oral product containing 1.5 mg of nicotine, but it’s also a moot point—at least for now. Altria hasn’t manufactured or sold VERVE since 2018, and the company has not said that it intends to put VERVE back into production.

While it was being test-marketed in Virginia in 2012, Campaign for Tobacco-Free Kids President Matthew Myers complained that Verve was an example of why the FDA urgently needed to capture authority of non-combustible nicotine products. The FDA did just that in 2016, issuing the Deeming Rule that granted the FDA dominion over all consumer products made with tobacco-derived nicotine.

Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I’m a member of the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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2 years ago

Trump should have never signed the PACT ACT without further evaluation. A lot of people will die because there’s no other enjoyable option than plain juices or go back to the bacco. #wevapewevote

King Magnolia
King Magnolia
2 years ago

It is my opinion that the FDA should’ve taken authority over ALL nicotine products, not just non-combustibles. Then seen what smokers had to say about this when the FDA took those away, period – that being the most unhealthy legal nicotine product to date. When there are no options left for adults either, I think it has become a double-edged sword keeping the “youth” “safe”. The only reason all of this is happening to begin with is because the tobacco industry has enough money to lobby these legislators into making laws that keep smoking ? in the game and everything… Read more »