On July 7th, 2020, news broke that the FDA had authorised the IQOS tobacco heating system as modified risk tobacco heating products (MRHPs). IQOS is the second set of products to be authorised as MRHPs and is the first ever set of exposure modification orders which allow the product to be marketed to customers in the USA as “ containing a reduced level of or presenting a reduced exposure to a substance or as being free of a substance when the issuance of the order is expected to benefit the health of the population ” .

IQOS is an electronic device which heats tobacco rather than burning it. This reduces the production of harmful chemicals.

The FDA have authorised the marketing of IQOS modified risk tobacco heating products as they have evidence from scientific studies that switching from traditional cigarettes to the IQOS system significantly lowers the user’s exposure to harmful chemicals. They also found that the IQOS aerosol contains less toxic chemicals than cigarette smoke.

The FDA are quick to point out that despite the authorisation of IQOS as MRHPs, the products are not recognised as safe or FDA approved.

The authorisation requires Philip Morris Products to conduct post-market surveillance in order to understand the impact on consumer perception, behaviour and health. This includes conducting a toxicity study and working to prevent youth exposure to nicotine products.

The company will also need to ensure that they continue to comply with the requirements issued in their PMTA order .

The IQOS system has already been rolled out in countries including Japan, Spain and Italy. It brought in $900 million in sales in 2018 . Until recently, Philip Morris were not able to say that heating tobacco was safer than smoking. The FDA are still keen to say they don’t endorse the products despite authorising the IQOS system as MRHPs. 

Critics say that not enough research has been done on the potential dangers of IQOS. However, the FDA have scientific evidence that the system is significantly less harmful to users and those around them due to the lower exposure to the harmful chemicals released by smoking traditional cigarettes. However, those who oppose the system say that being safer than smoking is “not a high bar”.

This FDA approval means that more companies may follow in Philip Morris’ footsteps and start designing their own heated tobacco devices. If the product becomes mainstream and smokers completely switch to using it, the risk of them developing smoking-related diseases may be reduced. However it isn’t clear yet whether current smokers would switch to the device and quit cigarettes, or simply use the device in between smoking. Researchers from the American Cancer Society studied cigarette sales in Japan from 2014 – 2018 and found that sales declined in correlation with IQOS launches.

However, it’s still early days for this product. Ideally, research would be carried out by independent parties, to study the products themselves and their impact on health, to learn whether they really are safe, as well as continuing to ensure that products such as these and e-cigarettes comply with regulations such as the PreMarketing Tobacco Application in the USA and the Tobacco Products Directive in the European Union.

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