FDA permits IQOS to be sold as a “reduced tobacco exposure product”

By May 28, 2021May 31st, 2021IQOS

The US Food & Drug Administration (FDA) announced on July 7 (local time) that “risk-modified (reduced) tobacco” from Philip Morris International (PMI)’s heat-not-burn tobacco product “IQOS”. The “Modified Risk Tobacco Products (MRTP) application” was approved for sale in the United States as a “reduced exposure tobacco product.”

What does this decision, based on US legislation, mean for the domestic tobacco market?

What are exposure-reduced tobacco products?

Reduced exposure means that “the number and amount of harmful and harmful components detected in the body of adult smokers who use the product is reduced compared to smoking cigarettes.”
Scientific validation of IQOS has been repeatedly shown.

Cigarettes “burn” tobacco leaves at temperatures above 600 degrees Celsius, producing smoke containing harmful components. On the other hand, IQOS “heatsticks” tobacco leaves at temperatures below 350 degrees Celsius, so it does not generate ash or smoke.

IQOS produces nicotine-containing aerosols, which significantly reduce the levels of harmful chemicals compared to cigarettes. A survey of 18 FDA-designated “hazardous substances to reduce” found that the chemicals contained in IQOS were reduced by more than 90% compared to cigarettes.

Based on these scientifically validated data, the FDA has determined that “risk reduction” is not supported at this time, but that “exposure reduction” is supported, and this decision was made.

It was concluded that IQOS is a radically different tobacco product from cigarettes and has been shown by previous scientific validation data to be a better option for adult smokers who continue to smoke.

In this decision, the FDA has indicated that selling IQOS with the following communications is appropriate to promote public health.

  • IQOS heatsticks tobacco leaves without burning
  • This will significantly reduce the amount of harmful and harmful components generated.
  • Scientific research shows that a complete switch from traditional cigarettes to IQOS reduces exposure of adult smokers to harmful and harmful components in the body.

A chance to think about how regulations should be according to risk characteristics

Philip Morris Japan (PMJ) held an online briefing for the press on July 21, following the FDA’s permission to sell IQOS as a reduced-exposure tobacco product.
Mr. Satoshi Inoue, Executive Vice President of PMJ, said, “For health reasons, it is best not to start smoking and to quit smoking.” We would like you to switch to a scientifically proven smoke-free product, “he called for a switch from cigarettes to heat-not-burn tobacco.

In addition, this decision gives an example of tobacco regulation in the US legal framework, but “In Japan, not all tobacco products are treated in the same way, but based on scientific data, the risk characteristics of the products I hope this will be an opportunity to think about how the regulations should be adapted. ”

The government and public health authorities will be closely watching how to distinguish between smoke-free alternative products and cigarettes and regulate them.

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