US regulator authorises IQOS as modified risk tobacco product

The US Food and Drug Administration (FDA) has authorised the marketing of IQOS, Philip Morris International’s (PMI) electrically heated tobacco system, as a modified risk tobacco product (MRTP).

The “exposure modification” orders from the FDA is issued when the products is expected to benefit public health. It permits the marketing of a product as containing a reduced level of or presenting a reduced exposure to a substance or as being free of a substance.

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

“The FDA will closely monitor how IQOS is used by consumers to determine if these products meet this potential and do not cause increased use among youth.”

The FDA noted that available evidence to date shows that the IQOS system, which heats tobacco without burning it, significantly reduces the production of harmful and potentially harmful chemicals.

“Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals,” it added.

Terming the decision as a “historic public health milestone,” PMI said the order provides a regulatory example to differentiate smoke-free alternatives from cigarettes to promote the public health.

“Now—more than ever—there is an urgent need for a fundamentally different conversation on a cooperative approach to achieve a smoke-free future,” commented André Calantzopoulos, PMI’s chief executive.

“The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health.”

PMI said an estimated 10.6 million adult smokers around the world have already stopped smoking and switched to IQOS as of 31 March 2020.

The FDA, however, rejected a claim by Philip Morris for a “risk modification” order, the second type of MRTP order. The regulator said the evidence did not support issuing risk modification orders at this time.

The company also needs to conduct post-market surveillance and studies to determine the impact of the order on consumer perception, behavior and health.