From America came the approval to marketing of Iqos cigarettes by Philip Morris. Since last April 30, in fact, the US Food and Drug Administration (FDA) has confirmed that the electronic tobacco heating system of Philip Morris International it is "an instrument suitable for the purpose of protecting public health and has authorized its sale throughout the American territory", as stated in the company's official press release.
This is the first electronic system for heating tobacco to receive marketing authorization in the US.
“The FDA's decision to authorize the marketing of Iqos in the US 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 to continuing to smoke. In just two years, 7.3 million people around the world gave up cigarettes and switched completely to Iqos. The FDA decision grants this opportunity to American adult smokers. All of us at PMI are determined to replace cigarettes with smoke-free alternatives that combine sophisticated technology and a rigorous scientific validation process. The FDA's announcement is a historic milestone,” commented André Calantzopoulos, CEO of Philip Morris International.
The decision of the FDA, the American body that deals with the regulation of food and pharmaceutical products, comes following the overall assessment of the request presented by Philip Morris International for the U.S. market introduction of tobacco products filed with the same agency in 2017.
“A choice made following a rigorous verification process that took into account both the scientific evidence presented by Philip Morris and that currently available in peer-reviewed reading. The rigorous scientific process carried out by the FDA in recent years represents an example of how different actors, respecting their roles, can work together to solve a problem such as that of smoking and stimulates us to move forward in this direction to continue to put further evidence in support of alternative products, such as Iqos, is available to the scientific community and regulatory bodies, helping to fuel the debate on harm reduction”, explained Marco Hannappel, new CEO of Philip Morris Italy.
Through the FDA's scientific evaluation of the company's submitted filings, the US agency found that smoking the cigarette produced by the Iqos Tobacco Heating System contains fewer toxic chemicals than commonly known cigarette smoke, and many of the identified toxins are present at lower levels than cigarette smoke. However, as the FDA note continues, the American agency places stringent restrictions on the marketing of heated tobacco products, aimed at preventing access and exposure of young people to new products. To have obtained the marketing authorization are the Iqos device, “Marlboro Heatsticks”, “Marlboro Smooth Menthol Heatsticks” and “Marlboro Fresh Menthol Heatsticks”. This decision allows the listed products to be sold within the United States, but does not imply that these products are safe or "FDA-approved," explained Mitch Zeller, JD, director of the FDA's Center for Tobacco Products.
“Ensuring that new tobacco products undergo robust premarket evaluation by the FDA is a key part of our mission to protect society, especially young people, and reduce tobacco-related disease and deaths. The authorization of new tobacco products does not mean that they are safe, but the verification process ensures that the marketing of such products is adequate for the protection of public health, taking into account the risks and benefits for the population as a whole. This includes how these products may impact nicotine and tobacco use by young people and the potential for these products to completely displace adult smokers away from combustible cigarette use,” said Mitch Zeller, JD, director of the FDA Center for Tobacco Products,” Zeller concluded.
According to Philip Morris's official note, the news has "significant relevance for the Italian market since the heated tobacco products authorized for sale in the States will initially be produced by Philip Morris International in Bologna, where the first and most important industrial plant of the company entirely dedicated to innovative products. A growth prospect for Philip Morris Manufacturing & Technology Bologna, if we consider that the American market represents the largest market in the world after China”.
As per the 2018 sales data published by Philip Morris International, the heated tobacco product units sold in the markets are almost doubled compared to the previous year by +93,2%, going from 22,9 billion units in 2017 to 44,3 in 2018.
As of March 31, 2019, there are more than 10 million Iqos consumers globally, of which the 70% quit smoking to switch entirely to Iqos, currently available in 47 markets.
