ARLINGTON HEIGHTS, IL (April 30, 2019) – The U.S. Food and Drug Administration (FDA) today approved a product made by Philip Morris International (PMI) that is an alternative to smoking conventional cigarettes. The device, called IQOS, is similar to vaping and e-cigarettes in that it delivers nicotine to the user without the harmful toxins that come with smoking.
The IQOS is a tube that gently heats up a stick of tobacco, but does not burn it, and the user inhales the vapor, which contains controllable amounts of nicotine. It has been available outside the United States for several years.
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“The approval was issued two years (or one million smoker deaths) after PMI’s application, which is about a year and a half past the agency’s own deadline. IQOS is only the second product approved under the Premarket Tobacco Product Applications (PMTA) pathway. The first was in 2015 for eight general snus products from Swedish Match.
“The FDA action is both good and bad news for e-cigarette and vapor manufacturers and retailers. The good news is that the PMTA process works. The bad news is that it took years, and hundreds of millions of research dollars, for PMI to obtain this approval. By 2022, manufacturers and retailers – who already sell tens of thousands of e-cigarettes and vapor products but don’t have the resources of PMI – will be required to submit PMTAs to the FDA, or risk having them ordered off the market.”
“In a significant development for tobacco harm reduction, I must applaud the U.S. Food and Drug Administration for allowing one of the most-revolutionary tobacco harm reduction products to hit the U.S. market.
“Millions of Americans suffer an addiction to combustible cigarettes. Many of these people have tried every imaginable nicotine replacement therapy option available to no avail. Newer tobacco-harm-reduction devices have come about in the last 10 to 20 years, including e-cigarettes and vaping devices, and heat-not-burn products, such as IQOS.
“In America, there are 34 million U.S. adult smokers and only 10 million adult vapers, indicating the e-cigarettes have not gone far enough to reach the millions of adult smokers that continue to smoke.
“Heat-not-burn technology is a unique product quite similar to a cigarette that is appealing to millions of current of adult smokers and provides them with a tobacco-harm-reduction product that fits their needs. As a technology that has already advanced in other markets, it is exciting to see the possibility of millions of more American adult smokers having access to these tobacco-harm-reduction products.”
“It’s very encouraging news to see the FDA take positive steps on tobacco harm reduction with today’s announcement on IQOS. This ruling is recognition that expediting safer alternatives to traditional combustible tobacco products will save lives, improve public health, and ultimately deliver cost savings for health care expenditures. Let’s hope this is a sign that the agency is adopting a broader harm reduction approach while increasing consumer choice and paving the way for technological innovation in this space.”
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