The FDA Will Take More Time To Determine If Benefits Of Juul Products Outweigh Harm

Sep 9, 2021
Originally published on September 9, 2021 8:21 pm
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SCOTT DETROW, HOST:

The FDA released a set of decisions today on which e-cigarette products can be sold in the U.S. and which will not be allowed on the market. But the agency did not make a decision on whether JUUL products, which account for 40% of the e-cigarette market - whether they can continue to be sold. NPR's Allison Aubrey joins us.

Hey, Allison.

ALLISON AUBREY, BYLINE: Hey there, Scott.

DETROW: So what has the agency decided so far?

AUBREY: Well, the FDA has reviewed hundreds of applications from the makers of electronic nicotine products to determine if the benefit for adult users who are trying to quit cigarettes outweighs the risk to youth who use the products and become addicted. So far, the agency has denied about 130 or so applications, covering more than 900,000 flavored vaping products. The FDA says these applications lacked sufficient evidence of a benefit to adult smokers, and many sound like products that were really designed to appeal to teenagers - flavors such as apple crumble, Dr. Cola, cinnamon toast cereal. Sounds like something you'd want to eat.

DETROW: Yeah.

AUBREY: So these products will not be allowed to be sold in the U.S. But the agency has yet to make a decision on some of the big players in this space, including, as you pointed out, JUUL.

DETROW: But we mentioned 40% of the market. Why did they not make a determination on JUUL?

AUBREY: You know, it's a big one. I mean, JUUL is asking to continue to sell both its tobacco and menthol-flavored products with two different concentrations of nicotine. The company has really tried to pivot from being the brand associated with teens to a company focused on harm reduction for adult smokers.

Now, JUUL has been in kind of a reset mode, trying to make the case to regulators that its products can be beneficial for adults trying to quit cigarettes. And, you know, JUUL has such name recognition. It controls 40% of the market, as we just said. It's clearly a big player. But the FDA has been under pressure from anti-tobacco advocacy groups to deny JUUL's application. Here is Erika Sward of the American Lung Association.

ERIKA SWARD: No JUUL product, whether it be tobacco-flavored or menthol-flavored, should be allowed to remain on the market. And the history and their actions are clear that they're interested in addicting a new generation.

AUBREY: Now, an FDA spokesperson told me this afternoon that the agency is still evaluating JUUL's application, that it's been devoting tremendous resources to this and other applications and that many of the remaining applications are in what they say are the final stages of review.

DETROW: OK, but since JUUL was not included, will today's actions make any difference when it comes to reducing teens' access to these vaping products?

AUBREY: You know, the anti-tobacco groups say today's announcements are kind of a step in the right direction. I mean, remember, the FDA was ordered by a federal judge to take action by today as part of a lawsuit brought by a number of these anti-tobacco groups. The agency was asked to make a determination on all of the e-cigarette products, and this just hasn't happened yet. Here is Matt Myers of the Campaign for Tobacco-Free Kids.

MATT MYERS: The most important decisions are those that have not yet been made. If we're going to reverse the youth e-cigarette epidemic, FDA has to eliminate the flavored products by the major manufacturers and they have to do so quickly.

AUBREY: And he argues that this should include JUUL and its menthol products, that they should come off the market. He says menthol e-cigarettes are currently driving the vaping epidemic among young people.

DETROW: Yeah. That's NPR health correspondent Allison Aubrey.

Thanks, Allison.

AUBREY: Thank you. Transcript provided by NPR, Copyright NPR.