FDA Authorization of iQOS: The Good, The Bad and The Ugly

 

Clive Bates recently described his reactions to the FDA re-authorization of iQOS, Philip Morris International’s innovative heat-not-burn tobacco. The FDA action means that PMI can market the products in the U.S., and make claims the FDA deems "appropriate to promote the public health" under Section 911 of the Tobacco Control Act.  Clive’s description follows:

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I think the FDA's announcement is positive and good for public health to have a wider range of smoke-free, far safer products available as alternatives to cigarettes, with authorised risk communication suitable for adult consumers.

But there is a far bigger story here, in my view: the technology lag imposed on U.S. consumers by the FDA's authorisation regime.  

The iQOS 2.4 and 3.0 are essentially obsolete, and iQOS 3.0 is only available in a few isolated U.S. markets. They were launched internationally in 2016 and 2018, respectively.  These are based on PMI's original blade-based heating technology (first launched in 2014 in Japan), which has been superseded by an induction-based heating system in the iQOS ILUMA. The ILUMA products offer a material advance over blade-based systems from a consumer perspective: cleaner, less routine maintenance, more reliable, and improved aerosol consistency. The ILUMA was launched internationally in 2021, with a new version, the ILUMA i, launched in 2024 outside the United States.

The manufacturer, PMI, submitted a combined PMTA and MRTP for ILUMA in October 2023, and the FDA took until March 2024 merely to accept the application.  In April 2026, the first ILUMA remains under FDA review. So American consumers have access only to obsolete technology that is now about 10 years old. These obsolete products are not sold anywhere else in the world. In the UK, the available iQOS product is the ILUMA i (e.g., see here). 

There is a similarly dismal story with the Juul products.  The Juul 2 was available in the UK in September 2021, but it is still not available in the United States. Juul Labs Inc. submitted Pre-Market Tobacco Applications for the Juul 2 in July 2023.  The PMTA evaluation is required by law to be completed in 180 days under Section 910c(1)A. The original Juul, the only one that can be sold legally in the United States, was launched in 2015 and took just over 1,800 days to pass through FDA... 10x the statutory maximum. The Juul 2 application has now been with the FDA for more than 1,000 days. A new version of the Juul cannot be that far away and is probably necessary for the European market.

The FDA's evaluation system is so cumbersome that it cannot meet its own statutory timetable and limits Americans to obsolete technologies, mostly from a small pool of relatively large manufacturers that can cope with the extreme burdens of its process. This serves to protect the cigarette trade and is driving a giant illicit market - over 80% of the U.S. vape market consists of unauthorised products (Juul Labs estimate). 

If you are interested in what the FDA could do about this, please see our report: Regulating the Tobacco and Nicotine Market in the American Public Interest: A Reform Agenda for the FDA, September 2025, for the American Enterprise Institute, by Sally Satel, Brad Rodu, Don Kenkel and me.

Clive Bates

High School Smoking Almost Gone, Vaping Way Down Too

 

Recently the U.S. Food and Drug Administration released data from the 2024 and 2025 National Youth Tobacco Surveys (NYTS).  A few specialty media articles reported some general findings (here, here and here), but otherwise the release was a non-event.

I downloaded the NYTS data and conducted an analysis of high school vaping and smoking, seen in the chart at left.  This explains the lack of media coverage: the teen vaping crisis is over.

The chart clearly shows that exclusive smoking among high schoolers was almost extinct in 2025, at 0.5%.  In fact, it’s getting so rare that it’s hard to attach labels.  Dual smoking-vaping (1.3%) and exclusive vaping (5.7%) were also much lower in 2025 than just five years earlier (3.6% and 16% respectively).

Where is the celebration?  We are close to achieving a smoke-free generation of youth and young adults, which in a few decades will transition to a smoking-disease-free generation of older adults. 

For years I complained about CDC manipulation of the NYTS numbers as it withheld the data and spun the narratives (examples here, here, here, here and here).  I am grateful that the FDA released the NYTS data without spin or fanfare, a big departure from previous releases when the CDC Office of Smoking and Health was the source. 

April 15: Note to the post.  The original chart contained a small error in the 2025 column.  H/T to Charles Gardner for pointing this out.  Correction has been made.

 

Announcing a New Lecture Series on Tobacco Harm Reduction

 

I am pleased to announce a new lecture series on the medical and scientific evidence for tobacco harm reduction.

This week, I am publishing “Nicotine, Correcting Misperceptions.”  The lecture is divided into an introduction and six easily digestible segments; run time and links are below. 

Nicotine, Correcting Misperceptions

Introduction     2:45  (link here)         

Comparing nicotine with caffeine, and contrasting positive and negative effects of nicotine on the brain, in the context of addiction     3:43  (link here)

Comparing nicotine delivery among combustible, smoke-free oral and aerosol tobacco and medicinal nicotine products         14:35  (link here)

Distinguishing the health effects of nicotine from those of combustible and smoke-free tobacco     14:35  (link here)

Weighing the evidence of nicotine use during pregnancy     4:00  (link here)

Investigating how the medical facts about nicotine have been exaggerated and distorted     5:00  (link here)

Valuing long-term nicotine maintenance and tobacco harm reduction     4:46  (link here)

 

You might think that you already know everything about nicotine.  So go ahead…TEST YOUR KNOWLEDGE OF NICOTINE by taking a short quiz!

You’ll get immediate feedback on your score, and the answers might prompt you to watch some of the segments.  Enjoy!

Note: While I originally created these lectures as a continuing medical education (CME) course (more information here), they do not presently convey CME credit, but are available to all who are interested in safer tobacco products for themselves, their families and friends.

I will publish the remaining topics soon.

Washington Post Attack on E-Cigarettes Deserves Emergency Room Treatment

 

Dr. Leana Wen, an emergency physician and Washington Post columnist, attacked tobacco harm reduction in a Post column last week, “The New Nicotine Product Replacing e‑Cigarettes to Addict Teens” (paywalled).  It dealt mainly with Zyn nicotine pouches, but it touched on the gamut of safer cigarette substitutes. 

Matt Holman, Ph.D., Chief Scientific and Regulatory Strategy Officer at U.S. Philip Morris International, has responded (here) with an accurate point-by-point rebuttal of Dr. Wen’s numerous misstatements. 

I’d like to focus on one especially egregious statement in Wen’s article: “Mitch Zeller, former director of the FDA’s Center for Tobacco Products, explained that as much as 70 percent of people who vape continue to smoke. He showed me industry data from two years ago that showed 84 percent of adult pouch users kept up cigarette use.”

I was astonished that Zeller would cite 70 percent, when he can readily access updated information from the gold standard CDC National Health Interview Survey (NHIS). In this chart of the smoking status of 17.8 million vapers estimated from the 2024 NHIS, the highest percentage were former smokers, while only 26 percent were current smokers.

While dual use is a transition period for many smokers, dual use has another, more ominous driver: misinformation from federal agencies and major medical organizations.  For example, Matt Holman noted: “under the helm of Mr. Zeller, [the FDA Center for Tobacco Products] authorized more than 2,800 cigarette products to be marketed while only authorizing 30 novel smoke-free products (heated tobacco products, Swedish snus, and vapes). These actions resulting in 100 times more authorizations for combusted tobacco than novel smoke-free products are in direct opposition of CTP’s stated mission ‘To protect the public health of the U.S. population from tobacco-related death and disease...’”

Additionally, in 2018, CTP director Zeller launched the FDA Real Cost E-Cigarette Campaign, which is a misinformation circus.  It ostensibly targets kids, but I calculated – using the FDA’s formula – that this campaign also dissuaded hundreds of thousands of smokers from switching to safer vape products (here).

The Washington Post should run a major correction for Dr. Wen’s article.