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. 





Wednesday, March 27, 2019

Tobacco Sales to Kids Is a Problem For States, Not Retailers


FDA Commissioner Scott Gottlieb recently threatened that “some flavored e-cigarette products will no longer be sold at all…other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access…” (here)

Dr. Gottlieb blames the so-called youth vaping “epidemic” on illegal retail sales and “kid-friendly marketing.” (here)  Focusing so heavily on retailers, he ignores the fact that underage sales rates are extremely low in many states – Georgia (2.2%), Montana (2.7%), Hawaii (3.0%) and California (4.2%) for example, according to 2018 FDA inspection data – while violation rates in others is extremely high -- North Dakota, Michigan, Ohio and Nevada are close to 23% (here).

In order to explore the connection between retailers’ violations and state enforcement efforts, I downloaded FDA information on 26,000 inspections conducted in 2018 at national retail chain stores – Walgreens, Walmart, Rite Aid, Shell, Family Dollar, Dollar General, Circle K and 7-Eleven.  I calculated the rate of violations for these chains stores in each state (excluding Nevada and North Dakota, with very low numbers of inspections).   

The chart shows the combined results for these retailers.  Note that the x axis is the state rate, based on 146,000 inspections, and the y axis is the retailers’ rate, based on 26,000 inspections.  There is a strong correlation between violations in these chain stores and the state in which they were located (correlation coefficient, CC = +0.77).  The correlation is also seen with individual companies.  For example, Walgreens’ violation rate was 2.2% in Georgia (based on 46 inspections) and 17% in Ohio (with 229 inspections). 

Note that nearly all of the retailers’ rates are below the green diagonal line, showing that they were lower than the state rates in all jurisdictions except DC, Connecticut, Oregon, Minnesota, Alaska and Hawaii.

The FDA blames retailers for selling tobacco products to children, but it ignores the significant differences in violation rates among states.  Youths in Georgia, Montana, Hawaii and California can seldom buy tobacco products, suggesting that those states’ enforcement efforts are far more effective than the other 46 states. The simplest route to obtaining age restriction compliance seems to be FDA pressure for stronger state enforcement, rather than agency action against retailers or product categories.