Juul Labs Awaits FDA Decision On Vaping Products
With a Sept. 9 deadline looming, the clock is ticking for the Food and Drug Administration to decide if Juul Labs' vaping products should remain on the U.S. market as an alternative for smokers.
The New York Times on Monday reported on Juul's precarious status and how the FDA's decision may rest on two questions: "Will more smokers use Juul products as an off-ramp from traditional cigarettes than nonsmokers will use it as an on-ramp to nicotine? And can Juul really keep the products away from kids?"
Meanwhile, Juul may not be helping its cause in the eyes of the FDA. The same Times report offered a glimpse into Juul's efforts to change the perceptions of e-cigarettes in a move that likely backfired. The entire May-June issue of American Journal of Health Behavior consisted of 11 Juul-funded studies that cost $51,000 and made, among other arguments, that e-cigarettes could “avert millions of premature deaths in the U.S.”
The publication's decision to run the studies prompted three editorial board members to resign.
The Washington, D.C.-based company has not made public its 125,000-page application to the FDA and major health organizations have asked the FDA to reject Juul’s application. Should the FDA approve Juul products, the company will still be subject to thousands of lawsuits and face other business hurdles.
Juul's controversial popularity among young people has seen a steep decline with sales plummeting by $500 million. On June 28, Juul said it would pay $40 million to the state of North Carolina over allegations it aggressively marketed its products to young people.
Juul had denied any claims of intentionally targeting their products towards youths.
On the company's website, a page shows up that reads: "Our mission is to transition the world's billion adult smokers away from combustible cigarettes, eliminate their use, and combat underage usage of our products. To access all JUUL products and online benefits, you must start the age verification process to create a 21+ account."
Juul's public-relations battle bears similarities to the uphill struggles for the tobacco industry, which Juul has sought to avoid. Among other lawsuits, New York's attorney general in 2001 filed a lawsuit against the R.J. Reynolds Tobacco Co. for utilizing billboard advertising in violation of the tobacco Master Settlement Agreement.
“We have a bigger opportunity to convert smokers than ever before, but we will get that opportunity if and only if we continue to combat underage usage and continue to act like the highly regulated company that we are,” Joe Murillo, Juul’s chief regulatory officer, told the Times.
Founded in 2015, within three years Juul was the sixth most valuable U.S. startup, according to Dow Jones VentureSource.
In December 2018, Marlboro maker Altria Group paid $12.8 billion to acquire a 35% stake in the company. In January 2019, Altria reported that Juul posted more than $1 billion in sales in 2018, up from about $200 million in 2017.
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