‘Heat-not burn’ tobacco device approved in US

The US Food and Drug Administration has approved the sale of a "heat-not-burn" tobacco device but warned it had not declared its use safe.

The device, called IQOS (pronounced EYE-kose) is manufactured by Philip Morris International and differs from e-cigarettes because it uses tobacco rather than flavored liquid nicotine. The new device is designed to heat disposable tobacco sticks to produce a nicotine-rich aerosol that provides the taste of tobacco without releasing the dangerous chemicals created by lighting traditional cigarettes.

"While the authorization of new tobacco products doesn't mean they are safe, the review process makes certain that the marketing of the products is appropriate for the protection of the public health, taking into account the risks and benefits to the population as a whole," Mitch Zeller, director of the FDA's Center for Tobacco Products, said in a statement. "This includes how the products may impact youth use of nicotine and tobacco, and the potential for the products to completely move adult smokers away from use of combustible cigarettes."

The FDA said it would continue to scrutinize the device although it had approved its sale but did not set a deadline for further review.

In the US, Altria, the parent company of Philip Morris USA, will sell the IQOS device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks. Philip Morris International will sell the items overseas. Anti-tobacco activists have long warned the menthol flavor attracts young people and may make it harder for users to quit.

Philip Morris International first marketed the device in 2014 and it quickly became popular in Japan. The device is now available in 47 countries. Philip Morris filed its application to sell the device in the US in 2016.

IQOS will compete with vaping devices marketed by Juul Labs that now represent about 70 percent of sales in the sector. Altria invested $12.8 billion in the San Francisco-based Juul company. Anti-smoking advocates have criticized the company for an increase in teen vaping.

"The FDA's decision to authorize IQOS in the US is an important step forward for the approximately 40 million American men and women who smoke," Andre Calantzopoulos, CEO of Philip Morris International, said in a statement. "Some will quit. Most won't and for them IQOS offers a smoke-free alternative to continued smoking. In just two years, 7.3 million people around the world have abandoned cigarettes and switched completely to IQOS."

Calantzopoulos said the company is "determined to replace cigarettes with smoke-free alternatives''.

However, a study published in ERJ Open Research found heat-not-burn devices are apparently no safer than ordinary cigarettes and therefore may not be a healthier substitute for cigarettes.

While more research is needed into the new heat-not-burn devices, preliminary evidence suggests they "are not less toxic than conventional cigarettes," Dr Pawan Sharma, a researcher at the Wollcock Institute of Medical Research in Sydney, Australia, said in a research paper.

Pending further research, users should therefore not conclude heat-not-burn devices are safer than conventional cigarettes, Sharma wrote.

Sharma and his team found cigarette smoke and heated tobacco vapor are "highly toxic" to cells and the new device delivers nicotine at levels commonly associated with "chronic smokers''.

"What we do know is that damage to lung cells can destroy lung tissue leading to fatal diseases such as chronic obstructive pulmonary disease, lung cancer and pneumonia, and can increase the risk of developing asthma, so we should not assume that these devices are a safer option," he said.

In April Philip Morris International launched an insurance company called Reviti. It will initially sell life insurance in the UK with plans to expand into more markets overseas. Smokers will receive discounts if they stop, quit or switch to a possibly less carcinogenic product, like Philip Morris' vaping devices or its heated tobacco product IQOS.