The FDA is Threatening to Yank E-Cigarettes off the Market

The FDA is Threatening to Yank E-Cigarettes off the Market
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In the past year, it has become increasingly-evident that there is a vaping epidemic among the nation’s youth. Though it’s unknown how much of a ‘gateway’ vaping may be to regular tobacco use among teens and young adults, it’s certainly true that many more kids who wouldn’t smoke at all are trying e-cigarettes. To tackle the problem, the U.S. Food and Drug Administration (FDA) is threatening to remove e-cigarette products from the market.

Why not regular tobacco cigarettes? Let’s be honest – there’s too much money wrapped up in the tobacco industry to do that.

FDA Commissioner Scott Gottlieb said in mid-January that e-cigarette makers face an “existential threat” if they don’t take strict action to prevent youth vaping.

Read: Vaping May Be Overriding Efforts to Get Kids to Quit Smoking

“I still believe e-cigs offer an opportunity for currently addicted adult smokers to transition off cigarettes and onto products that may not have the same level of risks. But if youth use continues to rise, the entire category faces an existential threat.

I believe if every currently addicted adult smoker switched completely to e-cigs it would provide a tremendous public health gain. But that opportunity is in significant risk if kids’ use continues to rise.”

The rise in youth vaping is indeed shocking. From 2017 to 2018, there was a 78% increase in current e-cigarette use among high school students and a 48% increase among middle school students, the 2018 National Youth Tobacco Survey shows.

With e-cigarette use skyrocketing among teens and pre-teens, Gottlieb said he is ready to yank all vape products from store shelves if e-cigarette makers don’t take the problem seriously and make strides toward tackling the issue.

“[I]f the epidemic continues to mount, I’m sure that the debate will change to one of whether these products should continue to be marketed at all without authorized pre-market tobacco applications.

It could be ‘game over’ for some of these products until they can successfully traverse the regulatory process. I think the stakes are that high. And would be a blow for all of the currently addicted adult smokers who, I believe, could potentially benefit from these products.”

Groups such as the Campaign for Tobacco-Free Kids, the American Heart Association, and the American Cancer Society Cancer Action Network would love to see e-cigarette products go through the formal FDA approval process, and have lamented the fact that the products have made it onto store shelves without it. [2]

No More Messing Around

But now the FDA isn’t playing around. In September 2018, the agency gave e-cigarette manufacturers 2 months to come up with a plan to prevent the sale of their products to young people. Failure to do so, the FDA warned, could result in the agency requiring companies to change their sales and marketing practices, stop distributing products to retailers who sell to kids, and remove flavored e-cigarette and nicotine products from the market. The warning was aimed particularly at Juul, a popular USB drive-like vaping device which dominates the e-cigarette market and is especially popular among kids.

Then, in October 2018, the FDA raided the office of Juul and confiscated thousands of documents as part of an investigation into whether the company was deliberately targeting minors in its sales and marketing practices.

Later that month, Marlboro maker Altria said that it would pull its pod-based e-cigarettes from store shelves. And in November, Juul promised to pull some of its flavored pods from retail stores, shut down all of its social media accounts, and introduce stricter age-verification tools on its website.

But that appeared to be a ruse to buy time, as Juul and Altria announced earlier this month that Altria had agreed to purchase a 35% stake in Juul, and Altria had agreed to give Juul access to shelf space in 230,000 retail outlets where Marlboro cigarettes and other Altria products are sold.

Gottlieb is skeptical that e-cigarette companies take the youth vaping epidemic seriously.

“I have questions about whether they are living up to the very modest promises that they made. It matters if the e-cig makers can’t honor even modest, voluntary commitments that they made to the FDA.” [2]

Dr. Bonnie Halpern-Felsher, who studies youth e-cigarette use at Stanford Children’s Health, says the FDA isn’t doing itself or young people any favors by consistently pointing out that vape products are safer than combustible cigarettes.

“We need to stop saying that e-cigarettes are safe or safer and prevent e-cigarette companies from making these unauthorized risk claims. Youth hear them. We need to stop saying that e-cigarettes help adults stop smoking when there is not enough clear evidence that this is the case.

That is giving them the idea that they are therefore safe and okay to use.”


[1] Consumer Affairs

[2] NBC News