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Lawmakers Want the FDA to Remove Vaping Products from the Market Again

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04/09/2021
insidesources.com

insidesources.com

House Democrats have asked acting Food and Drug Administration (FDA) Commissioner Janet Woodcock to remove all vaping products from the market during an ongoing product approval process, despite evidence showing millions of Americans have used these alternatives to stop smoking traditional cigarettes.

“Flavored e-cigarettes are putting a new generation of kids at risk of nicotine addiction and the serious health harms that result from tobacco use. And these products are widely available and popular with kids,” notes the letter signed by Reps. Debbie Wasserman Schultz, D-Fla., Diana DeGette, D-Colo. and 40 of their colleagues.

The lawmakers believe the availability of certain flavored electronic cigarettes and vaping products still poses an immediate risk to potentially susceptible youth. Given the fruity flavors and the vast availability of these products, these Democrats want the FDA’s Center for Tobacco Products to take action by removing products from the market during a process known as the premarket tobacco applications pathway.

A law passed in 2009, the Tobacco Control Act, requires every tobacco product sold in the United States to go through a review process by the FDA.

Wasserman Shultz’s office clarified that the lawmakers have specifically asked the FDA to remove from the market all flavored e-cigarettes that are currently under review by the tobacco regulator. The letter asks the agency to “deny applications for any flavored e-cigarettes and other flavored tobacco products, and to deny issuing a marketing order for any e-cigarette that poses an increased risk of youth initiation or addiction.”

Industry groups and public health experts who see the benefit of e-cigarettes as a tool to help adults quit smoking urge caution to Woodcock and Mitch Zeller—the FDA’s tobacco chief.

“Zeller would be wise to ignore calls from members of the House Prohibition Caucus to disregard the clear language of the Tobacco Control Act on product authorizations,” said Gregory Conley, president of the American Vaping Association. “If these elected officials want to change the population-level health standard for PMTAs, the proper route is through legislation, not invective-filled, substance-free letters organized by lobbyists.”

Riccardo Polosa, a professor of internal medicine at the University of Catania in Italy, also told Inside Sources that the sentiments behind the letter from House Democrats are problematic.

“As it happened with the previous President Donald Trump, the new Biden administration is under pressure to ban or limited the e-cigarettes penetration in the market,” Polosa said. He added, “such political (but also moral) bias will result in the wiping out of any implementation of tobacco harm reduction policies thus restricting any less harmful alternatives to conventional cigarettes.”

The FDA and the CDC both recognize the potential harm reduction characteristics of these products. Tobacco control groups and their political allies in both parties, however, continue to promote the premise that vaping is as high-risk — or even worse –than smoking.

However, multiple studies have found that long-term smokers who give up traditional combustible cigarettes for vaping and e-cigarettes experience measurable health improvements. A 2019 study, for example, found improved vascular function compared with those who continued smoking. And Scotland’s National Health System declared in 2017 that “e-cigs are definitely less harmful than smoking,” and are incorporating this data into their goal to make the nation smoke-free as of 2034.

And in America, more smokers are either shifting toward vaping or quitting nicotine products altogether. That’s significant in a nation where, CDC data shows, 1 in 7 adults still use some form of tobacco.

The good news from a public health standpoint is that smoking among adults has been falling since 1965, when more than 40 percent of Americans were cigarette smokers. Today that number is around 14 percent, and part of that reduction correlates with an increase in the use of electronic cigarettes and other vaping products.

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