IQOS has been approved for sale in the United States, more than two years after Philip Morris submitted a premarket tobacco application to the FDA. The PMTA was submitted in March 2017, along with a modified risk (MRTP) application, which the agency has still not acted upon. And often whatever happens in terms of regulations in the US, find their way here to the UK and Europe
Although the application was submitted by manufacturer Philip Morris S.A. (a division of Philip Morris International — PMI), IQOS will be sold in the U.S. by Altria Group, the nation’s largest cigarette manufacturer. Its Marlboro brand is the single most popular American cigarette brand.
The FDA marketing order for IQOS represents the first approval of a PMTA for any inhalable consumer nicotine product. (The only previously approved PMTA was for several snus products made by Swedish Match.) No vape manufacturer has yet submitted a PMTA for an traditional vapor product.
Happy IQOS approval day!
Big public health win, but it’s time for @FDATobacco to approve the MRTP claims.
https://www.fda.gov/news-events/press-announcements/fda-permits-sale-iqos-tobacco-heating-system-through-premarket-tobacco-product-application-pathway …FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application
I’m not going to celebrate that only a multi billion dollar company can get through an excruciating regulatory process that takes years, but yes, it’s a net positive for public health.168:14 PM – Apr 30, 2019Twitter Ads info and privacySee SMM’s other Tweets
While news stories often confuse them, IQOS is a heat-not-burn tobacco product, not a vaping product that uses e-liquid. The IQOS “Tobacco Heating System” has three main parts: a handheld device, a charger, and small tobacco-filled sticks (called HeatSticks or HEETS) that are heated by the device to a temperature high enough to vaporize the tobacco, but too low to cause combustion. The tobacco is not burned as it is with cigarettes, and no smoke is created. Heat-not-burn (HNB) products are also sometimes called tobacco heating products.
Scientific studies have proved that IQOS is much safer than smoking, delivering fewer toxicants than combusted tobacco. It is generally accepted that IQOS is not quite as safe as modern vaping products, which contain no tobacco. Nevertheless, HNB devices like IQOS could provide a huge public health benefit if adopted by large numbers of people who currently smoke cigarettes. In Japan and South Korea, where IQOS has been available for several years, HNB devices have been credited for huge reductions in cigarette sales.
IQOS and other HNB products are unlikely to compete with e-cigarettes for the business of existing vapers. The experience and flavor of heated tobacco is much closer to smoking than to vaping, and the retail price of the HeatStick refills is expected to mirror the price of cigarettes. Because the FDA technically classifies the HeatSticks as cigarettes, Altria will be subject to taxes and fees on the refills similar to those on cigarettes, and prohibited from advertising on TV or radio.
According to the FDA, “While today’s action permits the tobacco products to be sold in the U.S., it does not mean these products are safe or ‘FDA approved.’” But despite the FDA’s protestations, most people will probably believe that the marketing order does confer an endorsement by the health regulator, and wonder why vaping products aren’t also “FDA approved.” And the FDA may use the approval as an example of how its tobacco regulatory system is fair to manufacturers.