iQOS: FDA authorizes the sale of a Philip Morris-free tobacco device

The Food and Drug Administration has approved Philip Morris's iQOS – a burn-free tobacco device designed to replace conventional cigarettes – for sale in the United States.

The product consists of a tube that gently warms the tobacco sticks instead of burning them, making it less harmful to inhale. Philip Morris has made the device a key part of his future growth. The device is already sold in dozens of other countries with varying degrees of success, but it sparked a debate among US health experts over whether iQOS could help or hinder public health.

In announcing this decision, the FDA has stated that the sale of these devices is "appropriate" for public health because "the products produce levels of toxins lower or lower than those of combustible cigarettes". products in order to prevent minors from using the device.

Health experts are concerned that the scheme will attract minors and people who did not smoke before, or that current smokers may adopt it without quitting smoking, exacerbating their health risks from tobacco rather than improving them. .

FDA experts and external experts have pointed out that although the product is authorized for sale, it has not been officially "approved" by the FDA. This is because all tobacco products are potentially harmful and addictive, and those who do not use them should continue to do so, the agency said.

Mitch Zeller, director of the FDA's Center for Tobacco Products, said the review process took into account the risks and benefits for the population as a whole. "This includes the impact of these products on the use of nicotine and tobacco by young people, and the potential of these products to completely keep adult smokers away from the use of combustible cigarettes," did he declare.

The agency has not yet made a decision regarding a separate application from the company to market the product stating that it is less harmful than other tobacco products or that it would reduce the risk of illness.

Philip Morris is the manufacturer of the device and thermal sticks, but Altria will sell it and market it in the United States.

Although the product is a "do not heat and do not burn" device, it meets the technical definition of a cigarette under the federal Food, Drugs and Cosmetics Act. Thus, Philip Morris and Altria will be banned from advertising the device on television and on the radio. In addition, said the FDA, it imposes restrictions on product marketing on websites and social media platforms.

While smoking in the United States has fallen to its all-time low, Philip Morris has made huge investments in iQOS and other smokeless tobacco products, spending $ 3 billion on developing them.

According to Philip Morris, using heat rather than flame, iQOS removes 90-95% of the toxic compounds in cigarette smoke.

The announcement made Tuesday by the FDA will certainly stimulate a lively debate in the coming months.

"Those who oppose it will rightly say that it is not safe. People on the other side are going to point out that it's less harmful than smoking and that it could be a good alternative, "said Michael Eriksen, former head of the CDC and tobacco expert at Georgia State University. smoking. "

Studies in other countries have yielded mixed results. Some smokers have tried alternatives, such as vaping or heated tobacco, by adopting it in addition to conventional smoking.

"If Americans end up using devices like this in addition to smoking, it would have been better for them never to have bought it," Eriksen said.

Now that iQOS is licensed for sales in the United States, the fierce debate over iQOS will focus on how it is marketed. Last year, an FDA advisory group rejected claims by Philip Morris International that iQOS reduces the risks and harms of smoking.

The committee agreed with the company's claim that its smokeless cigarette would reduce smokers' exposure to harmful toxins, but stated that the company had not conclusively proven that it would result in less damage and more harm. diseases.

How the FDA's marketing rules could affect the success of the device at the national level. If the FDA approves the company's commercialization request, iQOS would be the first tobacco product to carry the seal of the US government as a less harmful alternative to cigarettes – a marketing move for Philip Morris.