- E-cigarette makers face an existential threat. By May, they must submit applications to the U.S. Food and Drug Administration proving that their products provide a net benefit to public health. If a company fails to make its case, the FDA has the power to order its products off the market.
"I don't see it as a surmountable hurdle," Suzanne Colby, a tobacco researcher at Brown University, said of the FDA standard for public health benefits."The data look like their product differentially attracts youth instead of adults, in such great numbers." Some studies show dual use could be more harmful than smoking alone. A study last December found people who used both products tested higher than cigarette smokers for a range of volatile organic compounds and other toxins associated with tobacco-related disease. A separate study last year of heart disease risk among e-cigarette users found that dual use was"more dangerous than using either product alone.
In written responses to questions from Reuters, Juul said it believes its products"already are playing a critical role in transitioning adult smokers from combustible cigarettes and have the potential to convert tens of millions of smokers in the U.S." The company cited studies it has commissioned showing that between 30% to 50% of adult smokers who use Juul"switch completely from smoking cigarettes within six months.
Anthony Hemsley, an executive for Japan Tobacco International's U.S. division, acknowledged the population-wide trends in e-cigarette and cigarette use. But he pointed out that the FDA's decision on net public health benefit will be made on a product-by-product basis - not across the entire industry. He added that Juul has"a significant challenge ahead of them, in overcoming the concerns that exist out there.
Graphic: Rise of vaping amid regulatory delays https://graphics.reuters.com/JUUL-ECIGARETTES-FDA/0100B4QR2G3/JUUL-ECIGARETTES-FDA2.jpgJuul and the FDA did not respond to questions on Gottlieb’s assertion that the agency should immediately remove Juul and similar products from the market. E-cigarettes have been available in the United States since at least 2007, but the FDA did not formally get authority over the industry until nine years later, in 2016.
Mmhmm'
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