FDA Tobacco Director Ignores 2.5 Million “Anecdotal Reports” About E-Cigarettes

A feature of this month’s annual meeting of the Smoke-Free Alternatives Trade Association (SFATA) was a videotaped interview with Mitch Zeller, the director of the FDA Center for Tobacco Products.  Following the video, I participated in a panel discussion of Zeller’s statements about e-cigarettes.

Mr. Zeller clearly implied that there was no population-level evidence that smokers had quit with e-cigarettes.  He said that the FDA is “absolutely aware of the anecdotal reports about individuals using e-cigarettes to help them quit, but we can’t make population-level policy on the basis of anecdotal reports…FDA is required to use a population health standard.” 

The FDA should also be required to acknowledge population evidence generated by federal surveys.  I informed the SFATA audience that the CDC has 2015 National Health Interview Survey data documenting that 2.5 million former smokers were current users of vapor products (that is, they were vaping every day or some days).  Given that CDC and FDA investigators work closely on the NHIS survey, it is inconceivable that the FDA doesn’t know this fact.  These 2.5 million former smokers are more than anecdotes.  They constitute population-level evidence. 

Also noteworthy: In May the CDC published smoking statistics from the 2015 NHIS (here), but it just produced information on e-cigarettes today (here).  Unsurprisingly, the CDC feigned alarm that 58.8% of vapors were current smokers (here) while ignoring the 2.5 million anecdotes.  In fact, my July 16 blog (here) remains the sole source for this information. 

I have previously documented that the CDC has withheld information about the relative safety of smokeless tobacco (here and here).  This egregious behavior continues to deny important health information to smokers, dippers and chewers.  The FDA’s refusal to acknowledge population data on e-cigarettes facilitates its effort to impose industry-killing regulations on the vapor market. 

The chief federal regulator of tobacco products should acknowledge government survey data showing that e-cigarettes have helped as many as 2.5 million Americans quit smoking and/or stay smoke-free.

Memo to Feds: Tobacco ≠ Smoking

Government officials almost always use the word “tobacco” when they are actually discussing “cigarettes” or “smoking”.        

This practice is apparent in a 2015 progress report from the Centers for Disease Control’s “Winnable Battles” campaign (here).  In the body of the document, the agency states that “smoking and exposure to tobacco smoke are responsible for more than 480,000 premature deaths annually, as well as at least $289 billion in health care expenses and other economic costs each year.” But, as shown in the image from the report, it’s headline and list of key strategies substitutes the catch-all term “tobacco” for “cigarettes” and “smoking” seven times.

The obvious purpose of this conflation of terms is furtherance of the government’s decades-long drive for tobacco prohibition (here). 

Eradication of all tobacco products could only be justified if all such products posed substantial risk to public health.  They do not.  Decades of scientific studies document that use of smokeless tobacco products is vastly safer than smoking (here, here and here).  Even strident tobacco control groups like the Truth Initiative acknowledge the difference (here).     

Maintaining that tobacco, cigarettes and smoking are synonymous is indefensible.

Intelligent Regulation of Smokeless Tobacco: Currently an Oxymoron

A commentary on “the political, social, genetic, and neuroscientific challenges in continuing an abstinence-only approach to nicotine use” was recently published by University of Ottawa Faculty of Law Adjunct Professor David Sweanor and student Adam Houston. 

In their Ottawa Law Review article (here), Sweanor and Houston observe that the “health catastrophe” of smoking “results not from the nicotine that smokers seek, but from the inhalation of smoke in order to obtain it”  They note that “non-combustion tobacco products — medicinal nicotine, various types of smokeless tobacco products, and now vapour products …effectively deliver nicotine without the inhalation of smoke,” and they believe that “shifting the market to non-combustion alternatives not only has the potential to achieve a public health breakthrough of truly historic significance, but is also a rather simple idea.”

According to Sweanor and Houston, “tobacco control policies hostage to an abstinence-only agenda” is so destructive “that even major US governmental health bodies avoid telling the public of the huge differential in risk between smokeless tobacco and cigarettes.”  I have repeatedly described the how the CDC doesn’t acknowledge the minimal risks of smokeless tobacco (here and here).

My decades-long effort to educate American tobacco consumers has been met with relentless opposition from anti-tobacco forces.  Sweanor and Houston show that wrong-headed opposition by health professionals is not unique to tobacco harm reduction.

Vaccines have been challenged for over 200 years.  “Dr. Edward Jenner is rightly honoured for the simple idea that cowpox [vaccination] could protect against smallpox, but his breakthrough in understanding the importance of vaccinations faced opposition…from those who saw such things as interfering with the will of God… As a result, widespread immunization took many decades to achieve.”

Physicians rejected hand-washing.  “The ground-breaking work of Dr. Ignác Semmelweis, on the simple idea of doctors washing their hands between conducting autopsies and attending to childbirth, was not merely ignored for decades, but his sanitary procedures were actually abandoned on the orders of his superiors, who did so after his measures had proven exceedingly effective at preventing an epidemic of unnecessary maternal and child deaths.” (emphasis in original)

Sweanor and Houston call for “intelligent regulatory oversight,” but it’s an oxymoron in the U.S. today, as evidenced by recent FDA actions on smokeless tobacco.  The FDA has conducted a misinformation campaign on cancer risks (here) that includes the conflation of “tobacco” with “smoking” (here).  Now, according to a report in The Hill (here), the FDA wants to lower the level of one or more tobacco-specific nitrosamines (TSNAs) in smokeless products. 

As I documented six years ago (here), TSNAs “are present [in tobacco products] in vanishingly small concentrations – mainly in the single-digit parts-per-million range… Despite decades of epidemiologic research, long-term use of Swedish or American smokeless tobacco products (other than dry powdered snuff) has not been associated in a significant way with ANY disease.”

I predicted that “anti-tobacco extremists will call for reductions. However, since there is virtually no evidence that current TSNA levels are associated with ANY measurable cancer risks, it is inconceivable that a reduction in levels will produce any measurable benefit.”

The Hill reports that the Campaign for Tobacco-Free Kids is taking credit for the FDA proposal.  CTFK’s Denis Henigan said, “We wrote to the agency and said well look if these products have such lower levels than clearly it's feasible to manufacture products with lower levels of carcinogens and you should draft a product standard.  It appears FDA has proposed to do something like that, something we asked for or close to it.”     

It is wrong for CTFK to drive FDA action in the absence of any scientific rationale related to risk reduction, when current risks are near zero.