The Union’s statement on FDA’s decision to authorise sale of IQOS in the US

The Union is concerned with the US Food and Drug Administration’s (FDA) decision this week to authorise Philip Morris International’s (PMI) IQOS – which heat rather than burn tobacco using a battery-powered system – for sale in the United States.

The FDA decision comes despite growing concerns from public health organisations about the health impacts of heated tobacco products (HTPs). The potential benefits and risks from HTPs to the public health remain undetermined but early independent research indicates that tobacco companies are understating the risks.

The Union is concerned that decisions like the FDA’s authorization of the sale of IQOS should not be made until more independent evidence on the health impact is available.

One of the biggest risks of allowing IQOS to be sold is the uptake of use among non-smokers and young people. We need much more evidence in this area before products should be allowed to be marketed in order to protect non-smokers and young people from the scourge of tobacco.

Furthermore, this decision sets a dangerous precedent to governments around the world who are similarly under pressure to allow IQOS to market. This is of particular concern in low- and middle-income countries where the tobacco industry is already aggressively targeting consumers and the tobacco control policies are not yet strong enough or well implemented to protect non-smokers and young people.

It is a small consolation that a decision on the separate modified risk tobacco product (MRTP) application that PMI also submitted for these products to market them with claims of reduced exposure or reduced risk has not yet been made. This means that PMI cannot make any explicit or implicit claim that IQOS are less harmful than cigarettes.

The FDA decision comes with marketing restrictions on the products in an effort to prevent youth access and exposure. This means that the products have been banned from advertising on TV and radio, and online marketing. The Union is concerned that the enforcement of IQOS marketing restrictions will be difficult, especially on social media, where children and young people are particularly vulnerable.

The Union urges the FDA to carefully monitor and analyse the marketing and sale of this product to protect children and young people. To assess the impact of the FDA’s decision, it will be crucial to establish post-market assessment of the uptake of IQOS among non-smokers and youth.