Is iqos authorized by FDA in the United States? Is new tobacco products really coming out?


On July 7, 2020, the U.S. Food and Drug Administration (FDA) authorized the sale of iqos, a heated tobacco product, in accordance with the federal food, drug and Cosmetic Act. As a result, the relevant industries hailed the victory, believing that the heated tobacco products were recognized as “harm reduction products”, and the “Prejudice” in the past would eventually disappear, and people could safely use such products.

Is that true? When we carefully analyze the relevant decisions of the US FDA, we will find that the FDA only approved the temporary market authorization limited to the United States, allowing Philip Morris (iqos manufacturer) to declare that iqos can reduce the production of harmful and potentially harmful chemicals.

At the same time, the US FDA Statement pointed out that “these products are neither safe nor” FDA approved products “, nor does FDA allow Philip Morris to make any statement or suggestion on risk reduction to mislead consumers. The US FDA has rejected the claim that iqos is less harmful or reduces health risks than other tobacco products. And clearly do not allow the relevant production enterprises to mislead consumers, so that they mistakenly believe that the use of iqos is safe. The FDA also requires Philip Morris to monitor the awareness and use of iqos among teenagers and prevent them from obtaining and using the product.

Reducing harmful substances ≠ reducing health risk

For traditional tobacco products, “coke reduction” is not equal to “harm reduction”, which has been the consensus of the international community. For the new tobacco products in recent years, reducing the production of harmful substances does not mean reducing the related health risks.

Due to the complexity of the relationship between hazardous substance exposure and health effects, long-term follow-up studies and analysis are needed to confirm the relationship. Due to the short marketing time of heated tobacco products, the potential hazards of this product have not been fully studied, and people’s perception of the risk of such products is still very limited.

The content of nicotine in heated tobacco products is similar to that in traditional cigarettes. We know that nicotine is highly toxic and highly addictive, so the use of heated tobacco products will also be addictive.

Secondly, the toxic substances released from heated tobacco products are similar to cigarette smoke, including many carcinogens. Although the concentration of some toxic substances in heated tobacco products is lower than that in traditional cigarettes, at least 20 kinds of toxic substances are still higher than the smoke produced by traditional cigarette combustion, and may contain new substances that are not found in traditional cigarette combustion. Therefore, there is a second-hand smoke problem in the same use of heated tobacco products, which is harmful to the surrounding people and the environment.

A statement issued by the World Health Organization on the matter reiterated that reducing exposure to hazardous chemicals in heated tobacco products would not make them harmless or reduce the risk to human health. In fact, the content of some toxins in the heated tobacco smoke is higher than that in the traditional cigarette smoke, and there are some toxins in the heated tobacco smoke that are not found in the traditional cigarette smoke. The health effects of exposure to these substances are unclear. Moreover, whether the use of such a new product will attract more young people to smoke, or even use a variety of tobacco products at the same time, it is still unclear whether such a new product will attract more young people to smoke. Therefore, in the case of insufficient evidence to prove that heated tobacco products are safer than traditional tobacco products, we should be alert to the relevant industries to market their products with the name of “harm reduction” products and mislead consumers.

Can iqos help quit smoking?

So another question we are concerned about, even if iqos is not a “harm reduction” product, can it help quit smoking?

Strictly speaking, iqos products are not electronic cigarettes, but heated tobacco products. Some people mistakenly believe that iqos is an electronic cigarette because it is used in a similar way to that of an electronic cigarette. It is heated by a battery powered heating system to atomize and inhale nicotine. Iqos is the representative of the heating temperature of tobacco products, the heating temperature is generally not more than 600 ℃, far lower than the central temperature of tobacco combustion (about 800 ℃), so it is also known as low-temperature smoke. Similar to the electronic cigarette, the whole process uses an electronic heating system without open fire, which is non combustion. However, a big difference is that the electronic cigarette heats the cooking oil, which usually includes nicotine, propylene glycol, glycerin, and some flavoring agents, while iqos heats tobacco sticks, so iqos is actually tobacco products.

Since iqos itself is a tobacco product, the argument that iqos helps to quit smoking is self defeating. It is only equivalent to switching from smoking a to smoking B, which is just a change of smoking method.

Under the current tobacco management system in China, iqos and other heated tobacco products are prohibited to be sold in China, but in fact, many consumers have used the product abroad or through purchasing on behalf of others, especially among some young people who advocate health and fashion. The so-called “tobacco products” are often misled by the so-called “smoking cessation” products.

There are no safe tobacco products, no safe way to smoke. At the present time when the epidemic situation of Xinguan is still spreading all over the world, we should cherish our health and cherish every free breath. The existing scientific evidence shows that smokers have a higher risk of developing into new crown and death. In order to better stabilize the anti epidemic achievements and protect their health, non-smokers, especially young people, should stay away from tobacco for life. Smokers should take evidence-based smoking cessation measures to quit smoking as soon as possible, including calling the quit hotline for support and receiving professional consultation and treatment through the smoking cessation clinic Etc.

(the author is a professor of School of public health, Fudan University)



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