In 2018, the FDA has completed a review of the device and found that it contains fewer toxic chemicals and lower levels of toxins than in cigarette smoke. This time, the FDA said it will set stringent restrictions on how the IQOS will be marketed, specifically online and on social media. Philip Morris will have to adhere to the same advertising and other federal restriction and must include a label warning that nicotine is addictive.
"Ensuring new tobacco products undergo a robust premarket evaluation by the FDA is a critical part of our mission to protect the public, particularly youth, and to reduce tobacco-related disease and death," said Mitch Zeller, FDA director for the Center for Tobacco Products.
No-Smoke Tobacco Sticks
Despite claims of reduced risk, this permission from the regulatory agency marks a win for Philip Morris and its parent company, Altria Group, as they try to pivot beyond cigarettes and market tobacco heating systems that are said to be safer than conventional and electronic cigarettes.
The pen-like IQOS device has three components: a holder, tobacco stick, and a charger. It also contains a ceramic and gold plate that heats Philip Morris-branded tobacco sticks up to 350 degrees Celsius. The device can heat tobacco to a temperature that is high enough to create vapor without the smoke. It will only heat up the tobacco sticks wrapped in paper and create an aerosol containing nicotine.
The product is currently available in 40 countries including Japan, Canada, Italy, and the UK. Altria will sell IQOS in the United States, with initial plans to introduce the device in Atlanta in the next few months. IQOS will compete with products of vaping giant Juul Labs, which currently controls more than 70 percent of the e-cigarette market in the United States.
More Risks Than Benefits
The product targets smokers who want to taste tobacco but with less smell and no smoke. However, experts in the UK have previously argued that "heat-not-burn" tobacco products are also harmful to health even though they are said to be safer than ordinary cigarettes.
The UK's Committee on Toxicity advisory panel said such devices produce a number of compounds of concern, including some that can cause cancer. There is also no clear evidence that tobacco sticks would help smokers quit.
FDA clarified that its authorization for marketing does not mean that tobacco heating products are safe. The agency has not yet even approved a separate application to declare IQOS as a lower-risk alternative to cigarettes.
"All tobacco products are potentially harmful and addictive and those who do not use tobacco products should continue not to," the FDA said in a statement.
Experts advised that quitting smoking altogether is still the best alternative, as there are no safe levels for smoking.