US ruling a boost to smoke-free alternatives

MANILA, Philippines — The move of the US Food and Drug Administration (FDA) to allow the marketing of electrically heated tobacco product IQOS as a modified risk tobacco product (MRTP) to reduce exposure to harmful substances showed how smoke-free alternatives to cigarettes could be regulated differently from cigarette products to promote public health, Philip Morris International (PMI) said.

In a statement, PMI chief executive officer André Calantzopoulos said the US FDA’s decision earlier this week to authorize the company to market IQOS as MRTP is a public health milestone.

“Many of the tens of millions of American men and women who smoke today will quit – but many won’t. Today’s decision makes it possible to inform these adults that switching completely to IQOS is a better choice than continuing to smoke,” he said.

He said IQOS is a different product from combustible cigarettes and must be regulated differently, as the US FDA has recognized.

“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 organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health,” he said.

IQOS is the first and only electronic nicotine product to be granted marketing orders through the FDA’s MRTP process.

For a company to be allowed to market its product as MRTP, it should show the US FDA that such product would or is expected to benefit the population as a whole.

The US FDA said in a statement that the agency authorized PMI to market IQOS with the following information: the product heats tobacco but does not burn it; it significantly reduces the production of harmful and potentially harmful chemicals and scientific studies show switching completely from conventional cigarettes to the IQOS system reduces the body’s exposure to harmful or potentially harmful chemicals.

It said it would closely monitor how IQOS is used by consumers to determine if the product does not cause increased use among youth.

It added the products are not safe so people, especially young people who do not currently use tobacco products, should not start using them or any other tobacco product.

The agency’s latest move follows a decision it made last year to authorize the commercialization of IQOS in the US.

“We are excited that this important decision will help guide the choices of adult smokers in the US. The best choice for health is to never start smoking or to quit altogether. For those who don’t quit, the best thing they can do is switch to a scientifically substantiated smoke-free product,” Calantzopoulos said.

As of end-March, PMI estimates there are 10.6 million adult smokers globally who have quit smoking and switched to IQOS.

“We believe that this decision can help to further accelerate the transition of US adults away from cigarettes. We, along with our licensee Altria, are committed to guarding against unintended use and fully support FDA’s focus on protecting youth,” Calantzopoulos said.

He said PMI would continue to work with the US FDA to provide any additional information needed in order to market IQOS with reduced risk claims.

He said “harnessing innovations like IQOS to dramatically 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.”