India Philip Morris welcomed the April 30, 2019 confirmation by the US Food and Drug Administration (FDA) that IQOS, Philip Morris International’s (PMI) electrically heated tobacco system, is appropriate for the protection of public health and its authorization for sale in the United States, and has urged the Indian government to create a regulatory environment for scientifically substantiated smoke-free alternatives.

IQOS is the first electrically heated tobacco product to qualify for sale in the US under the 2009 law that empowers the agency to regulate tobacco products, including regulatory responsibility for innovative products. The US now joins 47 other countries where IQOS can be legally sold.  In just two years, 7.3 million people around the world have abandoned cigarettes and switched completely to IQOS.

Unlike cigarettes, the IQOS system heats but does not burn tobacco.

Commenting on the FDA’s announcement, Alexander Reisch, Managing Director of IPM India Wholesale Trading, said, “I welcome the FDA’s decision and encourage everyone, including the Indian Government, to read the US FDA’s statement. Hopefully the Indian Government can one day create a regulatory environment where a variety of scientifically substantiated smoke-free alternatives can be made accessible to the more than 100 million adult smokers in India.”

PMI submitted a comprehensive body of scientific evidence in support of the application, which was submitted alongside an application in parallel for IQOS to be categorized as a ‘Modified Risk Tobacco Product”. This is still under review.

The company is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke.

“The FDA's announcement is a historic milestone. The 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 to continued smoking. All of us at PMI are determined to replace cigarettes with smoke-free alternatives that combine sophisticated technology and intensive scientific validation,” Alexander adds.

"The FDA order sets out clear commercialization guidelines, including marketing requirements, that maximize the opportunity for adults to switch from cigarettes, while minimizing unintended use. We fully support this objective, and would welcome the opportunity to engage with the Indian authorities to develop a set of similar high standards for commercialization of such products in India, which will ensure that these products reach only the right audience – current adult smokers.”, Alexander adds.