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FDA approves its first electrically heated tobacco device from IQOS

Late last month the United States Food and Drug Administration (FDA) confirmed that it approved an IQOS electrically heated tobacco system and deemed it appropriate for the protection of public health and authorised it for sale in the United States.

This makes the IQOS (owned by Philip Morris International, PMI) device the first electrically heated tobacco product to be approved by the FDA for sale in the US. This in accordance to the 2009 law that empowers the organisation to regulate tobacco products, including oversight of innovative products in the country.

“The FDA’s decision to authorise 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 wont. The IQOS offers a smoke-free alternative to continue smoking,” said PMI’s CEO, Andrй Calantzopoulos.

Furthermore this decision follows a comprehensive assessment of PMI’s pre-market tobacco product applications (PMTAs) filed with the FDA in 2017. PMI submitted a comprehensive body of scientific evidence in support of the PMTAs and of the parallel applications for IQOSs as a Modified Tobacco Product, which the FDA continues to review, the company explains.

“The order sets out clear commercialisation guidelines, including marketing requirements that maximise the opportunity for adults to switch from cigarettes, while minimising unintended use. We fully support this objective. FDA has set a high standard and we look forward to working with them to implement the order so that IQOS is reaching the right audience who are current smokers,” explained Calantzopoulos.

PMI adds that they are determined to replace cigarettes with smoke free-alternatives that combine sophisticated technology and intensive scientific validation. To date they have already gotten an estimated 7 million to switch from cigarettes to the IQOS system.

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