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. 

Federal E-Cigarette Data AWOL

Americans are familiar with the census, taken every 10 years by the U.S. Census Bureau, but few are aware that the Bureau regularly collects information on a range of demographic, social and economic characteristics through Current Population Survey (CPS) supplements, which are sponsored by various government agencies.

The National Cancer Institute regularly sponsors the CPS Tobacco Use Supplement (TUS), which was conducted most recently in May and August 2010, and January 2011 (information here).  These datasets and accompanying technical documentation are available for download and analysis by tobacco researchers (here). 

Surprisingly, another TUS, conducted in May 2011 and described in a technical document as a follow-up survey that includes information on e-cigarettes (here), has never been released.  This conflicts with Census Bureau guidance that supplements “are available anywhere from 6 to 18 months after data collection.” (here) 

The 36-month-and-counting delay is troubling. 

High ranking government officials have been campaigning against e-cigarettes for some time, creating demand for FDA regulation.  The NCI, sponsor of this TUS, has been a powerful opponent of anything related to tobacco harm reduction.  Is it possible that NCI officials are not releasing e-cigarette data until FDA regulations are issued?

The NCI has suppressed positive data in the past.  An NCI-sponsored supplement to the 2000 National Health Interview Survey asked current and former smokers the method they had used to try to quit smoking.  One response was “switch to smokeless tobacco.”  Carl Phillips and I published an analysis of this survey, noting that it provided the first population-level evidence that American men have quit smoking by switching to smokeless tobacco (here).

Five years later, despite the fact that tobacco harm reduction had gained increased visibility and more American smokers were likely making the switch, the NCI struck the switch-to-smokeless query from the survey, denying the public information about this cessation option.     

Public health requires public access to taxpayer-funded survey data.  NCI should be an ally in this regard, not an obstacle.

UCSF Redefines Youth Smoking; Journal’s Peer-Review Fails

The National Youth Tobacco Survey (NYTS) has been abused on an unprecedented scale by anti-tobacco forces.  First the Centers for Disease Control and Prevention released cherry-picked data, fabricating an epidemic of childhood e-cigarette use (discussed here and here).  Then the New England Journal of Medicine refused to correct an inaccurate and misleading portrayal of e-cigarette and cigarette usage (link here). 

Now we have the work of the University of California San Francisco’s Lauren Dutra and Stanton Glantz, who a use a dizzying array of statistical analyses of the NYTS to argue that e-cigarettes are a gateway to cigarettes for youth (discussed here).  The Dutra-Glantz study has been criticized by tobacco research and policy experts Clive Bates (here), Michael Siegel (here) and Carl Phillips (here).  The fabrication was called out by the American Cancer Society and the American Legacy Foundation (here).

After additional analysis, I have discovered major flaws in the Dutra-Glantz study that further undermine its credibility. 

First, it is difficult to accept their finding on smoking and e-cigarette use when, by all conventional standards, Dutra and Glantz have grossly underestimated youth smokers. They reported that current smoking prevalence was 5.0% in 2011, and 4.0% in 2012.  This is less than half the prevalence reported by the CDC and other authorities (see chart).  How could this have happened?

It turns out that Dutra and Glantz invented a new definition of current smoking for youth: one who has smoked 100 cigarettes in her lifetime AND smoked on at least one day in the past 30. The standard definition for a youth smoker used by the CDC and all other authorities is anyone who smoked a cigarette on at least one of the past 30 days.  Dutra and Glantz’s definition of current smoking for youth is also completely different from the definition they use for e-cigarette use (one day in the past 30).

Dr. Glantz knows the standard definition for current youth smoking, because he used it last year in his report on e-cigarette use among Korean youth (abstract here).

Valuable information in the NYTS surveys was obscured or ignored by Dutra-Glantz.  While providing incomprehensible tables of odds ratios to inappropriately link e-cigarettes use and smoking, they omitted basic information related to e-cigarette use.

The CDC data show that about 76% of current e-cigarette users are also current smokers, but the surveys contained additional information that helps interpret this e-cigarette and cigarette link.  The surveys provide insightful data on students’ use of other combusted products (pipes, cigars and hookah).  The following table places current e-cigarette users in four categories: (1) those who smoked only cigarettes, (2) those who smoked cigarettes and one of the other products, (3) those who smoked only the other products, and (4) or those who didn’t smoke.

Percentage of Current E-cigarette Users Also Currently Using Other Tobacco Products in the 2012 NYTS
Product	Percentage
Cigarettes Only	21
Cigarettes and Pipes, Cigars or Hookah	55
Pipes, Cigars or Hookah Only	10
No Other Products	13

It is clear that the majority of e-cigarette users were users of multiple products.  This is not surprising, as some youth tend to be risk-takers and experimenters.  The table also shows that only a tiny number of students (13%) used e-cigarettes but no other smoked product in the past 30 days. 

That the significantly-flawed Dutra-Glantz study was published in the Journal of the American Medical Association Pediatrics is an indictment of the medical publishing industry’s peer review process.  Unfortunately, journals generally under-scrutinize anti-tobacco submissions.  After publication, journals tend to reject corrections, absent a glaring key error.  But even that situation does not guarantee correction, as the New England Journal story shows (here).

Swedish Tax Proposal Threatens Successful Tobacco Harm Reduction

Sweden, which represents the world’s best example of the population effect of tobacco harm reduction, is considering increasing its snus tax by 22%, according to the Swedish national newspaper Aftonbladet.  An April 2 article claims “it would be the first time ever that a can of snus would cost more than a pack of cigarettes.”  Swedes are reportedly outraged by the proposal.  Public health experts should be outraged as well, given such a tax hike’s threat to the developed world’s lowest smoking and lung cancer rates.

As expected, the Karolinska Institute’s tobacco expert Hans Giljam expressed support for a higher snus tax.  However, even he admitted, “There is a risk that many will quit snus and move to cigarettes.  And if many start smoking instead of using snus, we will get sicker. That is a certainty.”

That is unquestionably the strangest endorsement of tobacco harm reduction ever heard.  Giljam couched his comment in dire, unfounded or exaggerated warnings about links between snus and a host of diseases, but he waffled on how much snus use triggers health effects.  “It takes decades of study to reach such conclusions.  It is one of the pedagogic problems we face; we don’t really know what the health effects of long-term snus usage are.”

In fact, decades of study have defined the long-term health effects snus use – nearly zero.  And even Giljam acknowledges that smoking is at least ten times more dangerous than using snus.  His support for equalizing taxes on snus and cigarettes is unfathomable.

This article is available only in Swedish (here), so the English translation I have could account for Giljam’s bizarre logic.  But I sincerely doubt it.  Like anti-tobacco extremists everywhere, those in Sweden not only completely ignore the phenomenal Swedish tobacco experience, they enthusiastically endorse policies that would destroy it.