FDA authorises marketing of IQOS as a modified risk tobacco product to help addicted smokers transition away from combustible cigarettes

This follows after the FDA authorised IQOS to be sold in the US in 2019.

The US Food and Drug Administration (FDA) authorised the marketing of IQOS, Philip Morris international’s (PMI) electrically heated tobacco system, as a modified risk tobacco product (MRTP), on 7 July. The agency found that an IQOS exposure modification order is appropriate to promote the public health and can reduce consumers’ exposure to harmful chemicals found in combustible cigarettes.

The FDA last year authorised IQOS to be sold in the US, and to date, IQOS is the first and only electronic nicotine product to be granted marketing orders through the FDA’s MRTP process. The FDA on Tuesday said that the available scientific evidence shows IQOS heats tobacco rather than burning it and this significantly reduces the production of harmful and potentially harmful chemicals, and switching completely to IQOS from combustible cigarette also reduces one’s exposure to such chemicals.

“Data submitted by the company shows that marketing these particular products with the authorised information could help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals, but only if they completely switch,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a statement.

PMI welcomes FDA’s announcement as it is a historic decision, it marks the first time the FDA has granted MRTP marketing orders for an innovative electronic alternative to combustible cigarettes. It illustrates that the IQOS system is distinctly different to combustible cigarettes and a better choice for adults who would otherwise continue smoking.

“IQOS is a fundamentally different product than combustible cigarettes and must be regulated differently, as the FDA has recognised. Now—more than ever—there is an urgent need for a fundamentally different conversation on a cooperative approach to achieve a smoke-free future. The FDA’s decision provides an important example of how governments and public health organisations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health,” said Brett Cooper, General Manager of Philip Morris Asia Limited.

It is believed that this milestone can help further accelerate the transition of adults away from combustible cigarettes, and is committed to guarding against unintended use and fully support FDA’s focus on protecting youth.

“This decision is a result of our ongoing commitment to put science at the forefront as we continue on our quest to replace cigarettes with smoke-free alternatives as quickly as possible,” Cooper added.

Harnessing innovations like smoking alternatives might be able to speed-up the decline in cigarette smoking is the opportunity of this century. Comprehensive, science-based regulation can help to rapidly shift adult smokers who would otherwise continue smoking to better options, while simultaneously guarding against unintended consequences.