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Prof. Dr. Mustafa Özdoğan · Medical Oncologist

On the FDA Allowing the Sale of IQOS, an E-Cigarette (a Tobacco Product That Burns at Low Heat)

On the FDA Allowing the Sale of IQOS, an E-Cigarette (a Tobacco Product That Burns at Low Heat)

On 07 July 2020, the United States Food and Drug Administration (FDA) announced that it had "authorized" the sale of the e-cigarette brand IQOS (authorization does not mean that it is an approved product).

Toward the end of 2019, the FDA had stated that it was considering a ban on all e-cigarettes and similar electronic nicotine delivery systems (ENDS). By January 2020, the FDA decided to stop the sale of flavored e-cigarette cartridges, which particularly appeal to children and adolescents. Instead of imposing a ban, only a warning had been issued. Nevertheless, this seemed to be a very positive development; looking at the news at that moment, an authority such as the FDA did not want flavored e-cigarette products to be sold. But when we look at the overall situation rather than a single moment, what happened to the promise made 4 months earlier to ban all e-cigarettes? After the "warning to stop" flavored cartridges announced in January, one of our articles included the following paragraph: "In conclusion, as an overall assessment, the fact that flavored e-cigarette cartridges will not be sold can be regarded as a positive development. However, while a ban on all e-cigarettes was being considered 4 months earlier, the continued sale of tobacco- and menthol-flavored cigarettes may be a major loss for us. This development, which could also clear the way for large e-cigarette manufacturers moving toward a monopoly, remains a significant threat given the alarming epidemic among young people. Moreover, in its announcement, the FDA specifically stated that it was not imposing a "ban" on flavored cartridges, a phrase that gives pause to those of us expecting enforcement on e-cigarettes."

We can readily say that the United States has never before witnessed a substance-use epidemic spreading as quickly as the e-cigarette epidemic among young people.

E-cigarettes are used by 27.5% of high school students and 10.5% of middle school students in America. In its announcement authorizing the sale of the IQOS product, the FDA draws attention to the high use of e-cigarette products among young people and recommends that people who do not use tobacco products never start using products such as IQOS either.

IQOS, developed by Philip Morris, is an e-cigarette marketed as a "tobacco product that is heated but does not burn." In a conventional cigarette, the burning temperature at the tip can reach 750 degrees, whereas IQOS is designed to provide more controlled burning. However, we do not consider the term "does not burn" or marketing it in this way appropriate; even if this product does not burn at 750 degrees, burning occurs at 350 degrees, and it is clear that calling this "heating rather than burning" would not be accurate. As with many substances, the higher the temperature at which tobacco burns, the more carcinogens (cancer-causing substances) it releases. "Burning" at a low temperature may reduce the amount of carcinogens released, but it does not eliminate them. On the other hand, consuming it more heavily and widely because it is considered less harmful, and lowering the age at which use begins, are major risks that are being overlooked.

In conclusion, it is important to state that these products are not safe. They should not be regarded as a treatment option. The FDA's authorization does not mean that these products are safe, approved, or harmless. As with every tobacco product, it should be emphasized that this product should also be avoided. The actual outcomes associated with the product will become clear through monitoring studies among young people.

Sources

FDA Authorizes Marketing of IQOS Tobacco Heating System with ‘Reduced Exposure’ Information (07.07.2020)
fda.gov 07 July 2020
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