US authorises sale of IQOS 'Tobacco Heating System' in American market

The US federal health agency has authorised the sale of an electronic device designed as an alternative to conventional cigarettes in the American market. The Food and Drug Administration, however, placed stringent marketing restrictions on the IQOS 'Tobacco Heating System' in an effort to prevent youth access and exposure, the agency said in a statement on Tuesday.

Following a rigorous science-based review through the premarket tobacco product application (PMTA) pathway, the agency determined that authorising the Philip Morris International's electrically heated tobacco system for sale in the US market was "appropriate for the protection of public health". Among several key considerations, the products produce fewer or lower levels of some toxins than combustible cigarettes, it added.

Under the PMTA pathway, manufacturers must demonstrate to the agency, among other things, that marketing of the new tobacco product would be appropriate for the protection of public health. The product consists of a tube that heats up tobacco sticks instead of burning them. The products authorised for sale include the IQOS device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks, the statement said.

The agency said that while it permits the tobacco products to be sold in the US, it does not mean these products are safe or "FDA approved." "All tobacco products are potentially harmful and addictive and those who do not use tobacco products should continue not to," it added.

"While the authorisation of new tobacco products does not mean they are safe, the review process makes certain that the marketing of the products is appropriate for the protection of the public health," said Mitch Zeller, director of the FDA's Center for Tobacco Products. The agency will be keeping a close watch on the marketplace, including how the company is marketing these products, Zeller said, adding it will take necessary actions to ensure the continued sale of these products in the US remains appropriate.

Through the scientific evaluation of the company's applications, peer-reviewed published literature and other sources, the agency found that the aerosol produced by the IQOS Tobacco Heating System contains fewer toxic chemicals than cigarette smoke, and many of the toxins identified are present at lower levels than in cigarette smoke, the FDA statement said. Additionally, IQOS delivers nicotine in levels close to combustible cigarettes suggesting a likelihood that IQOS users may be able to completely transition away from combustible cigarettes and use IQOS exclusively, it said.

The agency also asked the manufacturer to include a warning about the addictiveness of nicotine, in addition to other warnings required for cigarettes, on all package labels and advertisements for these products. The PMI estimates that approximately 7.3 million adult smokers around the world have already stopped smoking and switched to PMI's heat-not-burn product, which is currently available for sale in 47 markets in key cities or nationwide under the IQOS brand, the company said.

According to the Washington Post, an estimated 14 per cent of adults in the United States, or 34 million adults, smoke cigarettes. "Smoking remains the country's leading cause of preventable disease and death, accounting for about 1 in 5 deaths every year. Companies and some experts have pushed devices like IQOS as possible alternatives to help bring down those rates," the paper said.

Over 11 per cent of 6.4 million deaths worldwide were caused by smoking in 2015 and 52.2 per cent of them took place in China, India, the US, and Russia, according to the estimates in the Global Burden of Disease (GBD) study published in the medical journal The Lancet in 2017.