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Statement From Vital Strategies On The FDA’s Decision To Approve IQOS For Sale In The USA

(New York, USA) — Vital Strategies today expressed concern over the US Food and Drug Administration’s decision to approve Philip Morris International’s IQOS product for sale in the United States. The FDA has made this decision in spite of increasing concern about the potential health impacts of e-cigarettes and devices such as IQOS, and rising e-cigarette use among children and teens, which is strongly associated with eventual initiation of tobacco use.

Vital Strategies Senior Advisor for Science, Dr. Neil Schluger said:

“As the FDA states, IQOS is a tobacco product, and there is no safe level of tobacco use. Users may be exposed to fewer or lower levels of certain chemicals compared with combustible cigarettes, but there are no long-term human studies to provide assurances on safety. This product should not be used by non-smokers, currently not exposing themselves to tobacco-related health risks, and no-one should assume this product can be used without risking nicotine addiction, and potentially their health.

“IQOS will be treated as a tobacco product, barred from advertising on TV and radio and limited in its ability to market online, but use by non-smokers, especially children, is still a concern as these new products will be available through a vast retail market. We urge the FDA to carefully monitor the marketing and sale of  this product, to ensure that children and youth are protected. The FDA should also apply to IQOS all regulations that pertain to combustible cigarettes – including bans on use in smoke-free public places.

“Smoking rates in the US are at all time lows. The introduction and mass marketing of e-cigarettes and IQOS puts that at risk, almost guaranteeing that more people will start to use tobacco products. We’re also concerned that IQOS features one of the world’s most recognizable combustible cigarette tobacco brands (IQOS devices use Marlboro-branded ‘heatsticks’) and that flavored heatsticks are available. There is strong potential for cross-marketing, and disruption to efforts to regulate flavored tobacco products, which encourage tobacco initiation.

“To really protect health, we should continue to implement proven tobacco control strategies that deliver reductions in tobacco use, and not be distracted by big tobacco’s latest scheme.”

For more information about Vital Strategies’ work on tobacco control, visit

About Vital Strategies

Vital Strategies is a global health organization that believes every person should be protected by a strong public health system. We work with governments and civil society in 73 countries to design and implement evidence-based strategies that tackle their most pressing public health problems. Our goal is to see governments adopt promising interventions at scale as rapidly as possible. To find out more, please visit or Twitter @VitalStrat.