FDA Authorizes the Marketing of IQOS Devices


by James Bickford

Updated: August 7, 2020

iqos sale permitted by fda

On April 30th, 2019, the United States Food and Drug Administration completed a review of the Pre-Market Tobacco Product Application (PMTPA) submitted by Philip Morris International, and authorized them to market their IQOS products.

The FDA came to this decision after determining that marketing these new products would not be detrimental to the health of consumers. They believe IQOS products produce fewer harmful toxicants than traditional tobacco products.

While the authorization of new tobacco products doesn’t mean they are safe, the review process makes certain that the marketing of the products is appropriate for the protection of the public health, taking into account the risks and benefits to the population as a whole

– said Mitch Zeller, head of the FDA’s Center for Tobacco Products

Mr. Zeller went on to say in his statement that the FDA would be monitoring the frequency of youth uptake of these devices, and that they would take all precautions necessary under the law to make sure Philip Morris prevents their access to underage citizens.

The PMTPA pathway requires that all tobacco companies introducing a new product demonstrate that it will not endanger public health. The application must include scientific research that supports the position of the tobacco company.

What is an IQOS Device and Are They Safe?


An IQOS is a device that heats a tobacco stick to 350 degrees fahrenheit, but creates no combustion or smoke. The products available for use with the IQOS are Marlboro Heatsticks, Marlboro Smooth Menthol, and Marlboro Fresh Menthol Heatsticks. According to Philip Morris, this new product produces fewer toxic chemicals than traditional cigarettes.

After a six month study of random American adults, they determined that eight biomarkers for cancer had improved in those who had began using their device.

Dr. Stanton Glantz, a professor at the University of California San Francisco, is not convinced that these devices are safer than cigarettes. He examined the differences between IQOS and cigarettes and found no difference in 23 of 24 biomarkers for cancer in Americans and 10 of 13 for Japanese.
Staford also concerns regarding this news

He also reports that while the level of some toxicants in the devices and their products is lower, there are higher levels of others, some of which might cause liver damage. Dr. Glantz also believes that Philip Morris’s marketing techniques will attract younger consumers because of the way their products are marketed, designed, and packaged.

If even some of what Dr. Glantz says is true, especially what he says about the marketing techniques of Philip Morris, the FDA should not have authorized them to be marketed or sold in the United States.

What Does This Mean for the Future of IQOS?

IQOS devices are here to stay, and nothing short of an Act of Congress will get rid of them. Philip Morris likely had to spend a prodigious amount of time to get their application approved, and this amount of red tape will continue to restrict innovation in the tobacco and vape devices industries for years to come. Furthermore, this process of getting approval to sell or market such products is burdensome for small companies and start-ups, which likely do not have the resources to devote large amounts of time and money to go through the PMTPA.

No company, whether it sells tobacco, vape mods, or otherwise, should have to go through this complicated and expensive process of getting FDA approval. The United States has a free market system, and as a free people, Americans should decide what is healthy enough to go inside their bodies, not bureaucrats in Washington DC or professors on the FDA’s dole who have a deep seated animus against “big tobacco” companies.

Published: May 17, 2019Updated: August 7, 2020

James Bickford

My way of understanding the significance of vaping came not only through the disruption of smoking but its effects on society as a whole. Now I bring people to vaping and bring vaping to people. I love using new gear, writing in-depth reviews and generally nerding out about vaping to like-minded people.


Leave a comment

2 comments on “FDA Authorizes the Marketing of IQOS Devices

  • Ferrous

    June 16, 2019 at 1:38 am

    The free market can’t adequately address the dangers of vape technology fast enough to matter.

    It’s absurd to think any common consumer would be able to find reliable information about the health risks without a third party regulatory agency or institution of some sort.

  • MO Smoker

    June 15, 2019 at 1:03 am

    I believe you meant to say April 30, 2019 (not 2018)