PHILIP MORRIS INTERNATIONAL ANNOUNCES ABOUT PERMITTING PERMITTED SANITARY SUPERVISION MANAGEMENT OF US FOOD AND MEDICINES(FDA) FOR SALE DEVICES IQOS IN USA
New York, United States - April 30, 2019 - The US Food and Drug Administration (FDA) has confirmed that the IQOS tobacco heating electrical system, produced by Philip Morris International (PMI), is consistent with public health objectives and has allowed the sale of the device in the United States. This decision was made based on the results of a comprehensive assessment of the pre-sale application submitted by the FMI for review by the Office in 2017.
Unlike cigarettes, in IQOS there is no burning, but heating of tobacco. IQOS is the first electric tobacco heating system, approved for sale in the United States after the adoption of the Legislative Act in 2009, which entrusted the FDA with the regulation of tobacco products, including the supervision of innovative products.
PMI CEO Andre Kalantzopoulos commented on the news:
"The FDA's decision to allow IQOS to be sold in the United States is a crucial step towards almost 40 million Americans - men and women who smoke. Some of them will give up this habit, but most will not, and for them Iqos is a smokeless alternative to which they can go, instead of continuing to smoke. In just two years, 7.3 million people around the world have given up cigarettes and completely switched to IQOS. Today's FDA decision provides adult smokers with access to this alternative. Our company aims to replace cigarettes with smokeless alternative products, which are behind not only advanced technologies, but also serious scientific research and scrupulous evaluation. The FDA statement is a truly historic moment. "
Andre Calantzopoulos added: "The FDA decides on clear rules for introducing products to the market, including requirements for marketing practices that should maximize the opportunities for adult smokers to switch to new products without giving up cigarettes and at the same time ensure a minimum level of unintended use. We We fully support these goals. The FDA has set high standards, and we look forward to working with them to implement the ruling so that IQOS reaches its audience adult smokers. "
PMI will bring IQOS to the US market through an exclusive license agreement with Altria Group, Inc. and its subsidiary Philip Morris USA, which has the necessary infrastructure and market knowledge to successfully launch IQOS in the USA.
The FMI has submitted to the FDA a package of scientific documentation for IQOS pre-sale approval, and in parallel with this an application for IQOS to be recognized as “modified tobacco risk tobacco products”, the decision on which has not yet been made.