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The FDA Approves ‘Heat Not Burn’ IQOS Cigarettes For American Sale


The Food and Drug Administration (FDA) handed Philip Morris International (PMI) a victory yesterday as it approved for sale in the United States their IQOS product of “heat not burn” cigarettes. After three years of study, the FDA will now allow IQOS, which PMI and many scientists say drastically reduces harmful chemicals users ingest, to be sold in American stores.

The product is a battery-charged, handheld device into which “heat sticks,” which look like mini cigarettes, are inserted. The device heats the tobacco in the “heat sticks” to a level that releases nicotine, the addictive substance in tobacco, without any burning of the leaves. It is this lack of combustion that results in reduced harm. Unlike vaping, IQOS uses real tobacco, which means that for many of its users it more closely resembles the sensation of traditional smoking.

Commenting on the FDA’s announcement, André Calantzopoulos, PMI’s CEO, said:

The FDA’s decision to authorize IQOS in the U.S. is an important step forward for the approximately 40 million American men and women who smoke. Some will quit. Most won’t, and for them IQOS offers a smoke-free alternative to continued smoking. In just two years, 7.3 million people around the world have abandoned cigarettes and switched completely to IQOS. Today’s decision by FDA makes this opportunity available to American adult smokers. All of us at PMI are determined to replace cigarettes with smoke-free alternatives that combine sophisticated technology and intensive scientific validation. FDA’s announcement is a historic milestone.

For PMI, the decision could not have come too soon. Its American sister company, Altria, which will distribute IQOS in the United States, last year bought a large share in Juul, a vape product that has quickly taken up 70 percent of the market. This created tension between PMI and Altria, as the former saw the move as a detriment to their rollout of IQOS. Now Altria will be free to sell and promote IQOS, alongside Juul.

Over the past year, Juul has come under increasing attack for its sales to minors. The product has been part of the cause of an enormous spike in youth vaping. Importantly, the FDA decision on IQOS specifically stated that IQOS would not be attractive to youth users, a claim backed up by data from the 47 countries in which IQOS has been introduced.

But PMI’s battle with the FDA over IQOS is only half won. In 2016, along with its application to sell the product, PMI submitted an application for the product to receive a Modified Risk Tobacco Product (MRTP) label, introduced under the Obama administration, but which the FDA has never granted to a product. The MRTP label is essentially an FDA stamp of approval that a given product truly is less harmful than traditional smoking. That application is still pending.

The label is important not only because it gives consumers confidence that the product is actually less harmful, but it can also make the price point of IQOS significantly lower than other products. Two states so far—Kentucky and Connecticut—have already passed laws stating that products with the MRTP label will be taxed at half the rate of products without it.

Experts I have spoken to over the years tell me that this use of the tax code to encourage the adoption of lower-risk products is a key component to lowering the overall rate of smoking. As more states adopt such tax remedies, the significant difference in price between more and less harmful products could be a game changer in smoking cessation.

It is intriguing that this decision comes quickly on the heels of the departure of former FDA commissioner Scott Gottlieb. During his tenure, Gottlieb soured on vaping and other reduced-risk products because of the rise of youth adoption. This decision could signal that the agency is now more open to these products.

All in all, the FDA decision is a positive move for Americans who wish to stop smoking traditional cigarettes. Having used the product myself, it is clear to me that the “heat not burn” method produces an experience much different from vaping, and research shows that the more alternatives that exist, the more people will stop using traditional cigarettes.

However, the FDA did say it would be closely monitoring the advertising PMI and Altria use to market IQOS, especially in regard to youth sales. On this issue, the entire industry would do well to take proactive steps to keep these products out of the hands of minors. But these concerns aside, yesterday’s decision was a good one for Americans looking to quit smoking. In short order, there will be another option for them, and that is extremely positive.