Thursday, April 18, 2019

FDA Holds IQOS Heat-Not-Burn Hostage, As Market Forces & Smoke-Free Products Slash Japan Cigarette Sales


The media has been silent about an unprecedented decline in cigarette consumption.  Japan Tobacco International reports (here) that cigarette sales in Japan declined 12% in 2018, largely due to sales of reduced-risk products.  The dominant reduced-risk product in Japan is Philip Morris International’s IQOS heat-not-burn HeatStick.

David Sweanor, a veteran tobacco harm reduction advocate in Canada, observed: “Japan provides a great lesson in how tobacco control groups ‘doing nothing’ and ‘staying out of the way’ has led to outperformance in reducing cigarette smoking.  A key question is what could be accomplished if these groups actively facilitated transitions away from combustibles.  Japan has reduced cigarette sales dramatically in just three years, Iceland reduced prevalence of cigarette smoking by 40% in three years, Norway reduced the cigarette market by half in a decade, Sweden achieved by far the lowest rates of smoking in Europe, and the U.S. appears to have tripled the rate of decline in cigarettes sales. All this largely despite, not because, of, actions by mainstream tobacco control. That should be a wake-up call.”

Clive Bates, another veteran THR advocate from the U.K., remarked: “The only mystery is why the skies over Tokyo are not dark with chartered planes bringing officials from WHO, FDA, Truth Initiative, the Campaign for Tobacco-Free Kids, the European Commission and others on an emergency mission to learn about this most extraordinary shift.  What is the secret they would find? ‘Do nothing, stay out of the way....’  There was very little involvement from tobacco control – the demise of cigarettes in Japan has been driven by the market and consumer preference.” 

Meanwhile, in the U.S., smokers can’t buy IQOS because the FDA has not approved PMI’s marketing application (known as an PMTA), which was submitted in March 2017.  Approval requires the company to demonstrate “that the new tobacco product is beneficial to the population as a whole.”  Nothing benefits a population more than the rapid deterioration of cigarette sales, as seen in Japan.

An FDA official recently indicated that a decision on IQOS will be issued by the end of this year.  That would mark the passing of 2.75 years from submission, and the untimely deaths of 1.3 million American smokers.

The FDA took eight months (335,000 dead smokers) to grant Swedish Match a PMTA for eight snus products in 2015 (here).  What will happen in 2022, when the FDA receives thousands of PMTAs from vapor manufacturers and retailers?



Thursday, April 11, 2019

Premium Cigars Threatened by Pending FDA Regulations, with Negligible Public Health Benefit


Chairman Marco Rubio convened a field hearing of the Senate Committee on Small Business & Entrepreneurship on April 5 in Tampa, Florida.  The focus was on proposed FDA regulations’ likely effect on premium cigar production and marketing.  I was invited to testify on the health effects of cigar smoking.  In addition to submitting formal testimony, available here, I made the following remarks at the hearing.

As an oral pathologist at a major cancer center 25 years ago, I discovered that Americans, including doctors, are grossly misinformed about the high health risks of cigarettes versus the vastly lower risks of dip and chew.  This launched my tobacco research program that has produced 70 publications in the peer-reviewed medical literature.

My research established that smokeless tobacco use is 98% less hazardous than smoking, and that extends to the risk for mouth cancer.   This was confirmed by a large recent study from federal and federally-funded investigators; they found that men who dipped or chewed tobacco had no excess risk for mouth cancer. Zero.
 
Differences in health effects are also well documented for combustible products.  First, some basic principles.  When you burn tobacco, you release nicotine and about 7,000 other chemicals.  Twenty to 30 years of 10 deep puffs on 20 to 30 cigarettes per day builds high risks for cancers, circulatory diseases and emphysema… leading to a high death toll. 

Cigars also involve burning tobacco, but patterns of use are completely different.  The FDA knows that the cigar category encompasses a wide spectrum of products.  On one end are premium cigars; the rest of the category largely consists of machine-made, mass-produced cigarillos, little cigars and filtered cigars. I will reference the latter group as “little cigars”.  In 2014 FDA staff estimated that less than one percent of Americans smoked premium cigars; most light up infrequently.  Consumers of little cigars smoke a lot more often, and they also tend to smoke cigarettes.

Premium cigar smokers fit another FDA label, primary (they never smoked cigarettes), as opposed to former smokers and dual users of both products.  This is important because adding cigarettes adds risk. 

In my submitted testimony I present detailed information from a published FDA analysis of 22 epidemiologic studies of the causes of death among cigar smokers, most of whom are men.   

The FDA study listed many diseases associated with cigarette smoking; the biggest killers are cancers, heart diseases, strokes and emphysema.  Consumption of one or two cigars per day was not associated with significantly increased deaths from any of these. 

To be clear, puffing or inhaling the smoke of burning tobacco is not a healthy activity.  But the FDA researchers misstated the facts when they concluded that “…cigar smoking carries many of the same health risks as cigarette smoking.”

All tobacco consumers deserve truthful information and guidance.  The sweeping FDA indictment ignores scientific evidence and misleads cigar smokers.  The following facts are indisputable: (1) in the U.S. the prevalence of cigar use, especially premium cigars, is very low; (2) premium products are used infrequently and in small numbers; and (3) they are puffed, not inhaled.  Low prevalence, infrequent use and reduced exposure translates into minimal harm at the population level. 

Conflation of cigarette smoking with dip and chew, vaping, cigar and pipe smoking falsely informs consumers that all tobacco products are equally dangerous.  When Congress gave the FDA regulation of tobacco products 10 years ago, it did not direct the agency to treat all tobacco products as equally hazardous.  Unfortunately, the FDA’s regulatory actions have done just that. The FDA’s current posture wastes government resources, undermines public health and does nothing to address the 500,000 annual deaths caused by cigarette smoking.



Tuesday, April 2, 2019

Some FDA Claims About Teen Vaping Confirmed, Others Evaporate


The Centers for Disease Control and Prevention just released the 2018 data for the National Youth Tobacco Survey (NYTS).  My analysis confirms the FDA claim of a substantial increase in vaping among high school students.  However, I also discovered some information that challenges the FDA commissioner’s narrative (here) that this “threatens to hook an entire generation of kids into a lifetime of addiction.”

As seen in the chart at left, current (past 30 days) dual use of combustible and electronic cigarettes rose from 4.2% the year before to 5.7% in 2018.  Exclusive e-cigarette use almost doubled, from 7.6% to 15.1%.  The only good news is that exclusive cigarette use declined from 3.6% to 2.6%. 

Frequency of use is seen in the table below, which displays the percentages of the estimated 14.4 million high school students in 2018 who were currently using cigarettes and/or e-cigarettes, by number of days in the past month.  For example, 76.6% of students used neither product (bold text, upper left), an 8 point decline from the year before.  Current users of e-cigarettes are in the red-bordered boxes.  In 2017, 60% of current vapers used the products 5 or fewer days (green text) – the equivalent of trying products at a party.  But in 2018, that percentage dropped to 49%.  In contrast, in 2017 only 20% of current high school vapers used the products 20-30 days (red text), i.e frequent users, which is suggestive of dependence.  That number grew to 28% in 2018.  Slightly over half of those were not currently using cigarettes (bold red text). 


These worrisome numbers fuel the government’s dire warning that e-cigarettes are creating a new generation of nicotine addicts.  However, these claims require context, which the newly available NYTS data provides.  For example, the FDA emphasized that 28% of high school vapers were frequent users in 2018.  However, only 25% of underage vapers were frequent users, compared with 41% of legal vapers.  Further analysis of frequent vapers according to their underage or legal status shows the following:
 
Table 2. Lifetime Cigarette Consumption of Frequent High School E-Cigarette Users, NYTS 2018
Lifetime Cigarette ConsumptionUnderageLegal



Not Current Smokers

Never smoked43.1%28.2%
1 puff to 5 cigarettes35.730.3
Half to 1 pack9.417.3
1-5 packs6.412.6
5+ packs5.511.6
All100%100%



Current Smokers

Never smoked0%2.8%
1 puff to 5 cigarettes16.15.6
Half to 1 pack19.725.0
1-5 packs20.015.8
5+ packs44.150.8
All100%100%

The table shows that most frequent e-cigarette users were not virgins with respect to cigarette smoking.  In the underage nonsmoking group, 57% of frequent vapers had smoked in the past.  The percentages were even higher among legal-age and current smokers.  These percentages will likely increase if cigars, smokeless tobacco and other tobacco products are included (as I explained years ago here).  These youths had already smoked, which counters Dr. Gottlieb’s assertion that “e-cigarette use…threatens to hook an entire generation of kids into a lifetime of addiction.”  Simply put, kids who use or try stuff, use or try other stuff.

I have noted previously that the FDA’s campaign to eliminate teen vaping has improperly focused on tobacco retailers (here and here).  The following table from the 2018 NYTS confirms that the dominant sources of e-cigarettes for underage high school users are friends, family and other individuals (71%), while the primary source for legal high school vapers are retailers (64%).  Raising the legal purchase age – Tobacco 21 – remains a viable way to curb underage use. (here)

Table 3. Source of E-Cigarettes for High School Vapers,* NYTS 2018

UnderageLegal



Friend58.0%24.9%
Family6.83.2
Other person6.68.0



Vape shop12.946.8
Gas, convenience store6.69.7
Internet3.92.0
Other store2.31.4
Drug store1.12.7
Grocery0.90.6
Mall kiosk0.90.7
All100%100%

* Reporting a single source (81% of all)(weighted).

I previously said that “The FDA’s Teen E-Cigarette-Addiction Epidemic Doesn’t Add Up” for 2017.  There is no question that e-cigarette use among high school students increased substantially in 2018.  However, analysis of NYTS data documents that the FDA claim that e-cigarettes from retailers are singlehandedly hooking an “entire generation of kids into a lifetime of addiction” is exaggerated and inaccurate.