The FDA’s Tobacco Products Scientific Advisory Committee today found that scientific evidence Philip Morris International provided contains serious gaps and was insufficient to support its claims that its IQOS heated tobacco product reduces the risks of tobacco-related disease or that it is likely to lead adult smokers to switch completely. Critically, Philip Morris also failed to provide FDA any evidence about the impact of the product on non-smoking youth.

In an 8-0 vote (with one abstention), the committee found that evidence presented by Philip Morris did not justify a claim that “Scientific studies have shown that switching completely from cigarettes to the IQOS system can reduce the risks of tobacco-related diseases.” In a 5-4 vote, the committee also found Philip Morris had not adequately supported a proposed claim that “Switching completely to IQOS presents less risk of harm than continuing to smoke cigarettes.”

On an 8-1 vote, the committee found that Philip Morris had demonstrated that “Scientific studies have shown that switching completely from cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.” However, a large majority of the committee found it was unlikely that smokers would switch completely to IQOS and that there is a significant likelihood that smokers would become long-term dual users of IQOS and traditional cigarettes. Even if IQOS does reduce exposure to harmful chemicals, these benefits would not be realized unless smokers switch completely to IQOS. Based on the available evidence, the committee expressed strong skepticism that this would happen.

In a final 9-0 vote, the committee found that Philip Morris had not demonstrated that, after viewing the company’s proposed modified risk labeling and advertising, consumers would accurately understand the risks of IQOS.


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