FDA on Tuesday announced it will allow Philip Morris International to sell a hand-held device designed to heat tobacco without burning it, but the agency has not determined whether to allow the company to market the product as a safer alternative to traditional cigarettes.
About the latest 'heat-not-burn' device
Unlike e-cigarettes, which slowly heat up a nicotine-laced liquid, Philip Morris' new reusable device uses real tobacco. The device, called IQOS, gently heats up sticks of compressed tobacco until they are hot enough to release an aerosol, but not hot enough to ignite and burn the tobacco like traditional cigarettes.
The new heat-not-burn device shuts off automatically after six minutes or 14 puffs, whichever comes first. According to Philip Morris, the device contains 90% to 95% lower levels of toxic chemicals found in traditional cigarette smoke because it is only producing a nicotine-containing aerosol.
The company spent $3 billion developing IQOS and other smokeless tobacco products, amid declining sales of combustible cigarettes. IQOS currently is available in 30 markets outside of the United States.
Philip Morris in separate applications requested FDA's approval to sell IQOS in the United States and to market IQOS as a less harmful alternative to cigarettes. Philip Morris said it would exclusively market IQOS to smokers, and estimated the device could save 90,000 lives over 20 years.
However, an FDA advisory panel in January 2018 rejected Philip Morris' claims that IQOS reduces the risks and harms of smoking. FDA is not required to follow a panel's recommendation, but experts say the agency typically does.
FDA OKs sales of IQOS
FDA on Tuesday said, after a two-year review of the product, it has determined that sales of IQOS in the U.S. market are "appropriate for the protection of the public health because, among several key considerations, the produc[t] produce[s] fewer or lower levels of some toxins than combustible cigarettes."
FDA noted that research on IQOS showed:
- Current cigarette smokers were the "most likely" group to use the device;
- Smokers who switch to completely using IQOS "will have reduced toxic exposures and this is likely to lead to less risk of tobacco-related diseases"; and
- There was "low uptake" of the device among "youth and current non-smokers."
FDA said its decision to allow Philip Morris to sell IQOS "does not mean these products are safe or 'FDA approved.'" The agency added, "All tobacco products are potentially harmful and addictive and those who do not use tobacco products should continue not to."
FDA noted that IQOS will be subject to laws banning television, radio, and print advertisements of cigarettes, as well as new restrictions on social media and online advertisements, in order to discourage teenagers from using the device. FDA said IQOS will carry a similar warning label as traditional cigarettes.
FDA said it is still reviewing Philip Morris' request to market IQOS as safer than other tobacco products.
Howard Willard—CEO of Philip Morris' parent company, Altria—said the company will launch sales of IQOS this summer in Atlanta "to learn as much as possible, as quickly as possible." The company plans to open its first IQOS retail store and multiple mobile retail units in the city.
Altria also intends to sell the device's tobacco sticks under the Marlboro brand in 500 convenience stores.
Philip Morris CEO André Calantzopoulos said, "FDA's decision to authorize IQOS in the U.S. is an important step forward for the approximately 40 million American men and women who smoke. Some will quit. Most won't, and for them IQOS offers a smoke-free alternative."
But the American Lung Association said it was "deeply concerned" by FDA's decision. The association said, "FDA must take steps to protect youth from beginning a tobacco addiction with this product."
Eric Lindblom, director for tobacco control and food and drug law at Georgetown University's O'Neill Institute for National and Global Health Law, said FDA could have explicitly stated IQOS should be used only as a substitute for other tobacco products. Lindblom, who has worked in FDA's tobacco center, said, "Instead of requiring constructive labeling and preventing harmful advertising, FDA is hoping that Altria and (Philip Morris) will market IQOS responsibly" (Maloney, Wall Street Journal, 4/30; Perrone, AP/USA Today, 4/30; Kirkham, Reuters, 4/30; LaVito, CNBC, 4/30; Owens, "Vitals," Axios, 5/1; FDA release, 4/30).
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