Nicotine/Tobacco Research and Policy Experts Endorse Tobacco Harm Reduction in Letter to World Health Organization

Fifty-three tobacco research and policy experts from 15 countries today endorsed many of the tobacco harm reduction principles that I have advocated for 20 years.  In a widely publicized (here) open letter (available here) to Dr. Margaret Chan, director of the World Health Organization, they declared:

“Tobacco harm reduction is part of the solution, not part of the problem.  It could make a significant contribution to reducing the global burden of non-communicable diseases caused by smoking, and do so much faster than conventional strategies. If regulators treat low-risk nicotine products as traditional tobacco products and seek to reduce their use without recognising their potential as low-risk alternatives to smoking, they are improperly defining them as part of the problem.”

Just as I have done before (here), the experts warn that harsh regulation of e-cigarettes could have the unintended effect of protecting cigarettes:

“On a precautionary basis, regulators should avoid support for measures that could have the perverse effect of prolonging cigarette consumption. Policies that are excessively restrictive or burdensome on lower risk products can have the unintended consequence of protecting cigarettes from competition from less hazardous alternatives, and cause harm as a result. Every policy related to low risk, non-combustible nicotine products should be assessed for this risk.”

The letter’s signatories also endorse a tax strategy that I have promoted for many years (here):

“The tax regime for nicotine products should reflect risk and be organised to create incentives for users to switch from smoking to low risk harm reduction products. Excessive taxation of low risk products relative to combustible tobacco deters smokers from switching and will cause more smoking and harm than there otherwise would be.”

The letter points to the enormous public health gains that are possible with tobacco harm reduction:

“The potential for tobacco harm reduction products to reduce the burden of smoking related disease is very large, and these products could be among the most significant health innovations of the 21st Century – perhaps saving hundreds of millions of lives.”

It is encouraging to see such widespread international support for my long-held positions.

For Smokers Only: The E-Book With Bonus E-Cig Chapter

In 1994, I published the first professional medical articles documenting that smokeless tobacco contained satisfying doses of nicotine (in the Journal of the American Dental Association, here) and was vastly safer than smoking (in Nature, here), and I proposed “that smokeless tobacco be recommended as a cigarette substitute by persons who cannot stop smoking.” (in the American Journal of the Medical Sciences, here).

My scientific articles drew massive opposition.  The National Cancer Institute investigated my university, claiming that my strategy was unethical (documented in Jacob Sullum’s excellent book, For Your Own Good, available here) as other medical groups launched vicious attacks.  

One fact was beyond contradiction: Smokeless tobacco use was at least 98% safer than smoking.  While scientific evidence for tobacco harm reduction was overwhelming, smokers were completely uninformed about the lifesaving option of switching to a smoke-free delivery system.  This led me, in 1995, to address smokers directly with a book, “For Smokers Only: How Smokeless Tobacco Can Save Your Life.”

Recognizing the continuing relevance of this groundbreaking work, publisher Rick Newcombe of Sumner Books has just released it as an e-book, updated with a bonus chapter on e-cigarettes.  From exaggerated health scares to bogus gateway claims, opponents of e-cigarettes are using the same tactics they’ve used against other smokeless tobacco products for decades.   

Dr. Dean Edell, physician and host of an award-winning health radio program for 31 years (here), described For Smokers Only as “credible, logical and eminently do-able.”

The FDA Tobacco Product website offers as an example of “Health Fraud” (here) the suggestion “that a tobacco product is safer, less harmful, contains a reduced level or is free of a harmful substance, or presents a lower risk of tobacco-related disease compared to other tobacco products…To date, no tobacco products have met the requirements that would permit them (sic) to make claims of reduced risk or harm to users and nonusers of their regulated tobacco products.”

Applying that absurd definition, I have been conducting health fraud for 20 years.

Smokers, smokeless and e-cig users, get the help you deserve.  Download For Smokers Only from Amazon (here), Barnes and Noble (here) or ITunes (here).

Mouse, Rat & Cell Studies Don’t Make E-Cigarettes Carcinogenic

In determining what causes cancer in humans, epidemiologic and public health research is far superior to lab studies based on cells, mice or rats.  While the latter can provide important information about the biology of cancer, the vast majority of carcinogens have been discovered in studies of human exposures. 

Although numerous epidemiologic studies prove that smokers are more likely to contract a variety of cancers, decades of research on cells and animals have failed to establish which of the thousands of toxins in cigarette smoke cause human lung, bladder or esophagus cancer. 

Of the two major components of e-cigarette juice, we know this: Nicotine, the subject of thousands of studies, has never been shown to be a cancer-causing agent, and propylene glycol is generally recognized as safe for human use by the FDA. 

Regrettably, these facts haven’t stopped some researchers from scaremongering about e-cigarettes.  A study published in January (here) has led to a media frenzy suggesting that e-cigarette liquid may be as dangerous as smoke (here).  This is nonsense. 

Normal cells do not live forever.  But cancer cells are “immortalized” and are able to proliferate indefinitely.  The experiments reported in this study were conducted in immortalized cell cultures, which also included mutations of two important genes: p53, an anticancer gene that is active in normal cells, was “silenced”; and k-ras, a well-characterized oncogene, was “activated.” 

The researchers were essentially using a cancer cell line.  They measured the effect of two (unquantified) concentrations of nicotine e-cig solution and some sort of smoke extract on assays of growth and invasiveness after 10 days of exposure. 

Exposure of the cells to the low-nicotine e-cig solution and to the smoke extract had no effect on the invasiveness of the cells (a cancer trait).  They reported, “We will next examine the effects of high nicotine conditioned media on cell invasion,” indicating a future experiment.

The researchers noted that after 96 hours of exposure to e-cig solution, the cells showed changes in gene expression.  This is not particularly newsworthy.  Genes are the bits of DNA that tell cells what to do.  At any given time cells have many thousands of active genes.  Any environmental change can produce changes in the expression of large numbers of genes. 

In their effort to implicate nicotine, the researchers omitted information as to whether they had established appropriate experimental controls, such as exposure of the cells to other common agents such as caffeine or coffee extracts.

Cellular and molecular research explores the incredibly complicated biology of cancer, but it is of limited value in identifying carcinogens.  There are well established tests to determine if an agent is a possible mutagen, which is an indication that it might be cancer-causing.  A 2007 study of American smokeless products was essentially negative (here), which is completely consistent with epidemiologic studies.  It is likely that tests of e-cigarette liquids would produce similar results.   

Undistinguished research on smokeless tobacco products routinely generates headlines and soundbites best suited for the tabloids.  From a public health standpoint, it is shameful that researchers and media conflate vague, exaggerated and highly theoretical claims about e-cigarette juice to the very real risks of cigarettes.

The New York Times Plays Patsy for Anti-Tobacco Voices

In the tabloid tradition of “If it bleeds, it leads,” The New York Times ignored the lack of peer review and wasted no space on critical analysis when it ran a May 3 article by Matt Richtel titled “Some E-Cigarettes Deliver a Puff of Carcinogens.” (here). 

Based on two unpublished studies, the Times reported that “the high-power e-cigarettes known as tank systems produce formaldehyde, a known carcinogen, along with the nicotine-laced vapor that their users inhale.  The toxin is formed when liquid nicotine and other e-cigarette ingredients are subjected to high temperatures... This finding suggests that in certain conditions, [e-cigarettes] might expose their users to the same or even higher levels of carcinogenic formaldehyde as tobacco smoke.” 

The Times also said the new research shows that when users are “dripping” – placing drops of e-liquid directly onto an e-cig’s heating element – “formaldehyde and related toxins ‘approach the concentration in cigarettes.’”

The studies are the work of Roswell Park Cancer Institute assistant professor Maciej L. Goniewicz, and Alan Shihadeh at Virginia Commonwealth University and the American University in Beirut, respectively.  Goniewicz’s article will reportedly appear in the May 15 edition of Nicotine & Tobacco Research, while Shihadeh’s has not been accepted or peer-reviewed anywhere (the Times says it “is being prepared for submission to the same journal”). 

The Times story represents a deeply troubling development: the global publicizing of research before publication or even submission to a medical journal.

This high-profile pre-release tactic has become commonplace for anti-tobacco pronouncements from the CDC and other federal agencies.  Media outlets give these biased stories wide distribution free of critical analysis or balance.    

Historically, release of findings prior to a journal’s publication date was grounds for cancelling an article.  In a recent post I suggested that peer review of tobacco research is nearly nonexistent at some journals (here).  It is further disappointing that journals are active partners in the selective release of research findings to the public.

FDA Regulation: Defining E-Cigarettes As Tobacco Products

The FDA released a proposed rule to regulate “products that meet the statutory definition of ‘tobacco products’ …such as certain dissolvables, gels, hookah tobacco, electronic cigarettes, cigars, and pipe tobacco.” 

Media reports have primarily focused on the rule’s impact on e-cigarettes.  The FDA would ban sales to youths, allow flavorings and set a two-year timeframe for approval of existing products. 

The proposed regulation, a complex 241-page document, raises fundamental questions, including: What e-cigarette components are subject to regulation as tobacco products? 

Page seven of the draft rule states that the “Tobacco Control Act…defines the term ‘tobacco product’ to mean ‘any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.’”

Is the entire e-cigarette, including the liquid cartridge, heating element, battery and mouthpiece/switch, subject to regulation, or only the liquid and only if it contains nicotine? 

I believe the FDA could exert regulatory authority over e-liquids containing nicotine, but not over other e-cig components.  There is language in the draft rule supporting this: “Therefore, items such as hookah tongs, bags, cases, charcoal burners and holders, as well as cigar foil cutters, humidors, carriers, and lighters would be considered accessories and would not fall within the scope of this proposed rule.” 

The most relevant accessory named in this list is “lighters.”  The FDA does not regulate matches or butane lighters as tobacco products.  These accessory items are necessary in order to consume cigarettes, cigars or pipe tobacco, but they are not tobacco products per se.  The case could be made that all of the e-cig hardware – minus the liquid – is the equivalent of a match or lighter, and thus not subject to FDA regulation as a tobacco product. 

What about the Tobacco Control Act’s reference to “any component, part, or accessory of a tobacco product”?  I don’t believe that applies to e-cig hardware, but rather to the water, propylene glycol or glycerin, and any flavoring in e-cig liquids.  Again, language in the draft rule supports this interpretation: “Such examples would include air/smoke filters, tubes, papers, pouches, or flavorings used for any of the proposed deemed tobacco products (such as flavored hookah charcoals and hookah flavor enhancers) or cartridges for e-cigarettes.”  These components are used or consumed along with the tobacco. 

This might appear to be splitting hairs, but defining precisely what parts of e-cigarettes are subject to regulation under the Tobacco Control Act has huge implications.  If nicotine e-liquids are regulated tobacco products, manufacturers will be able to file market approvals based on substantial equivalence to liquids that were on the market in 2007.  In addition, they would have considerable flexibility to continue innovation and product development of hardware components, subject only to less-burdensome consumer safety standards.  Finally,  nicotine-containing e-liquids are the only component of e-cigarettes that would qualify for tobacco excise taxes.

Defining nicotine e-cigarette liquid as a tobacco product will bring clarity to the FDA deeming regulation, provide a basis for implementing unambiguous tobacco excise taxes, and promote innovation and product development.