The US Food and Drug Administration (FDA) has authorised Philip Morris International (PMI) to market its IQOS electronically heated tobacco system as a modified risk tobacco product (MRTP).

PMI was given the green light in April 2019 to sell IQOS, Marlboro HeatSticks, Marlboro Smooth Menthol HeatSticks and Marlboro Fresh Menthol HeatSticks in the US but with stringent marketing restrictions.

The latest action relates to separate MRTP applications for the products and now permits PMI to market them in a certain way.

This includes stating IQOS heats tobacco rather than burns it to significantly reduce the production of harmful and potentially harmful chemicals.

It marks the first time that tobacco products have received so-called ‘exposure modification’ orders, allowing them to be marketed as containing ‘a reduced level of or representing 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’.

‘HISTORIC PUBLIC HEALTH MILESTONE’

However, the action does not designate the products as either safe or FDA-approved, says the administration, and does not allow PMI to make any other modified risk claims related to this.

The authorisation requires the company to conduct post-market surveillance and studies to determine whether the MRTP orders remains appropriate, including assessing the likelihood of increased use among young people.

In a statement, PMI points out that the FDA’s decision shows IQOS is a ‘fundamentally different tobacco product and a better choice for adults who would otherwise continue smoking’.

It maintains that the action underlines how governments and public health organisations can regulate smoke-free alternatives to protect and promote public health.

“The FDA’s decision is a historic public health milestone,” declared André Calantzopoulos, Chief Executive Officer, PMI.

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

“FDA determined that scientific studies show that switching completely from conventional cigarettes to IQOS reduces exposure to harmful or potentially harmful chemicals.”

IQOS, which has proven highly popular in travel retail, produces a nicotine-containing aerosol by heating tobacco-filled sticks wrapped in paper.

The idea is by heating the tobacco rather than burning it, like in the case of cigarettes, IQOS limits the amount of harmful chemicals released.

“The best choice for health is to never start smoking or to quit altogether,” said  Calantzopoulos. “For those who don’t quit, the best thing they can do is switch to a scientifically substantiated smoke-free product.”

FDA WILL CLOSELY MONITOR USAGE

PMI estimates that as of 31 March, approximately 10.6 million adult smokers around the world have already stopped smoking and switched to IQOS.

The company has long voiced its aim to move towards a smoke-free future, one that eventually replaces cigarettes with alternative products.

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

“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.”

Mitch Zeller, J.D., Director of the FDA’s Center for Tobacco Products added: “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.

“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. It is important to note that these 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.”