WASHINGTON, D.C. — This afternoon, after two-plus years of waiting and delays, the Food & Drug Administration announced that it had approved premarket tobacco applications for Philip Morris’ IQOS device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks. This clears the way for Altria to distribute the product in the United States.
The FDA has yet to issue a decision on PMI’s modified risk tobacco product applications for the products. Through those applications, PMI is seeking to inform adult consumers that completely switching to IQOS reduces a user’s disease risk and/or exposure to harmful chemicals.
IQOS is not a traditional vaping product. Whereas traditional vaping products heat a liquid solution in order to produce a vapor, IQOS and and other tobacco vaping products use real tobacco. However, because there is no smoke, levels of harmful constituents found in cigarette smoke are eliminated or reduced by 90%-plus.
In Japan and South Korea, remarkable declines in cigarette sales have followed the introduction of IQOS and other tobacco vaping products to the market. For example, in Japan — where traditional vaping products are banned unless approved as drugs — the cigarette market has shrunk by a third in just three years. Heated tobacco products now make up 23% of the Japanese tobacco market.
AVA President Gregory Conley commented on the approval:
“This is a big win for public health and adult smokers who are seeking out satisfying reduced-risk alternatives. Heated tobacco products are not safer than traditional vaping products, but both products are clearly far less hazardous than smoking cigarettes. With IQOS freely available in several dozen countries, it would have been a travesty of justice if the FDA had denied this application.
“No one should confuse the FDA’s approval of IQOS with a sign that the FDA’s tobacco regulatory system is actually working in an efficient manner. PMI spent billions of dollars to establish the necessary scientific basis to file this application with the FDA. The FDA then ignored statutory requirements and took more than two years to issue a decision on just one part of PMI’s application. Unless the FDA’s regulatory system is reformed, no one but the largest of tobacco companies will ever get a vaping product through the FDA’s premarket approval process.”
“Now that the FDA has approved IQOS’ sale and marketing, the agency should act promptly on PMI’s application to truthfully inform adult smokers that completely switching to IQOS will reduce disease risks and chemical exposure. Hiding the truth from adult smokers, many of whom are confused about the potential benefits of smoke-free alternatives, is unjustifiable with the extensive science we have about this product.”
About the American Vaping Association
The American Vaping Association is a nonprofit organization that advocates for fair and sensible regulation of vapor products, otherwise known as electronic cigarettes, with the goal of maximizing the number of adult smokers who use these products to quit smoking. The AVA was founded by Gregory Conley, a consumer and industry advocate with a long track record of advocating for vapor products dating back to 2010.
We are dedicated to educating the public and government officials about public health benefits offered by vapor products, which are battery-powered devices that heat a liquid nicotine or nicotine-free solution and create an inhalable vapor. The AVA is not a trade group and does not speak for any particular businesses, including our industry sponsors.