FDA vote throws doubt on iQOS as reduced-risk product

Adjust Comment Print

Philip Morris International Inc told a US advisory panel on Wednesday that it expects around 6 million smokers to switch completely to its iQOS electronic tobacco device if the company is allowed to claim it is less risky than cigarettes.

The new technology, called IQOS, consists of a tube that gently heats up sticks of tobacco instead of burning them. If the panel endorsed IQOS, the device would be the first tobacco product marketed under a "modified risk" claim in the USA, suggesting it's safer than smoking.

The Johns Hopkins Bloomberg School of Public Health joined 16 other schools of public health across the USA and Canada today in stating that it will refuse research funding from an anti-smoking group backed by tobacco industry giant Philip Morris.

PMI wants FDA approval to market iQOS as providing reduced harm or reduced risk to public health when compared with combustible cigarettes. But even if I didn't think that, I'd be in favor of letting companies make accurate claims about the safety of their products. A cigarette burns at more than 1,000 degrees Fahrenheit, according to Philip Morris.

IQOS is said to come somewhere between trendy vaping products and traditional cigarettes on the scale of harm. Then the FDA will continue its review.

Philip Morris International (PM) shares fell after losing two key FDA committee votes on its smoke-free device, but recovered somewhat on a third ruling.

The FDA usually follows its advisory panels' recommendations, but not always. But animal and laboratory studies submitted by the company also suggested the chemicals could still be toxic and contribute to precancerous growths.

Results of a study in mice that could shed additional light on additional cancer risk are expected in June.

Under a 2009 law, the FDA gained authority to regulate a number of aspects of the tobacco industry.

"We are encouraged by the recognition of the risk reduction potential of IQOS that clearly emerged from the statements of the Committee members", the company said. In company studies, less than 20 percent of U.S. users switched completely to iQOS over six weeks.

Philip Morris and other global tobacco companies are diversifying their products beyond traditional cigarettes, making investments in e-cigarettes, heated tobacco products and chewable tobacco pouches, among other alternatives.

The cigarette has triggered debate and worries among health experts about whether IQOS will help or hurt public health in this country.

FDA Commissioner Scott Gottlieb recently proposed a broad tobacco policy shift that would reduce nicotine in cigarettes to "non-addictive" levels while increasing development of lower-risk alternatives for those unable to quit.