October 16, 2013

Stanton A. Glantz, PhD

Amendments to EU Tobacco Product Directive ignores scientific evidence and shamelessly promotes e-cigs

As Martin McKee wrote in the BMJ on October 16, the revisions just made to the draft EU Tobacco Products directive were a big win for the tobacco companies who are pushing e-cigarettes:

The most contentious area is e-cigarettes. The commission proposed treating them like any other nicotine delivery device and regulating them as drugs, a view supported by many governments, including that of the United Kingdom, after careful review of the evidence. The parliament was, however, influenced by intensive lobbying against this, although the meaning of the alternative text is unclear. Now, “all nicotine containing products” will be subject to the same restrictions on cross border advertising and sponsorship as cigarettes. Although cigarette brand names will be banned, the many flavourings, such as bubble gum and cotton candy, which increase their appeal to children, will not. However, the draft text goes on to urge governments to “ensure that they can be made available as widely as tobacco products,” reflecting unsubstantiated claims that they are a “game changer” for smoking cessation. The draft legislation fails to address the rapid growth in sales of products designed to resemble real cigarettes as closely as possible. This subterfuge is widely viewed as a way to renormalise smoking, a key goal of those seeking to recruit child smokers, and to counter some of the effects of smoking bans. [citations deleted]

Amazingly, the amendments justify this give-away to the tobacco companies with the statement -- which is not supported by the available scientific evidence -- that t e-cigarettes are effective cessation devices that should be made widely available when it states, “Given the potential of nicotine-containing products to aid smoking cessation, Member States should ensure that they can be made available as widely as tobacco products.”

This assertion is contradicted by the three large population-based studies of the effects of e-cigs on smoking cessation, one of which shows no benefit and the other two of which of which show lower levels of smoking cessation among e-cig users. 

The TPD prohibits e-cigarettes from containing a few of the less important additive (vitamins; caffeine, taurine and other stimulants associated with energy and vitality; and additives having coloring properties for emissions) but explicitly allows the additives that increase product appeal to children (e.g., chocolate, cherry, strawberry, licorice, menthol) that are explicitly prohibited from tobacco products (conventional cigarettes).

E-cigarette manufacturers and importers are nominally required to submit lists of all ingredients contained in and emissions resulting from the use of their products by brand name and type, and including quantities, but the TPD explicitly ensures protection for companies’ trade secrets, creating a loophole while will permit companies to avoid this disclosure requirement by claiming that their ingredient lists are trade secrets, as they have done in response to required submissions to the FDA in the United States.  This loophole will prevent meaningful public disclosure of ingredients.

The amended version of the TPD also added a definition of passive smoking -- "'Passive smoking' means the involuntary inhalation of smoke from the combustion of cigarettes or cigars or from the exhalation of one or more smokers" -- excludes the so-called "vapor" from e-cigarettes, as it only includes the "combustion of cigarettes or cigars."  This definition would thus permit the use of e-cigarettes in places that are currently regulated by laws that prohibit "passive smoking" despite the fact that e-cigs pollute the air that bystanders breathe (albiet by less than conventional cigarettes).

The TPD explicitly permits sales of e-cigarettes outside of pharmacies (including any that might be registered as “medicinal products”)

There are a few good changes that were made to the TPD:

  • The warning label requirements were made a bit more specific.  The amended TPD requires that “each unit packet and any outside packaging of nicotine- containing products carry the following health warning: ‘This product is intended for use by existing smokers. It contains nicotine which is a highly addictive substance.’”  The size and placement of the warning is the same as for tobacco products for smoking other than cigarettes and roll-your-own tobacco: 30%-35% of the external area of the unit pack and any outside packaging, depending of the number of a Member State’s official languages.
  • The TPD imposes the same “limitations on advertising, sponsorship, audiovisual commercial communication and product placement for tobacco products" as set out in existing EU regulations (Directives 2003/33/EC and 2010/13/EC)” to e-cigarettes.  It also prohibits co-branding of e-cigarettes and tobacco products: “tobacco trademarks, brand names and symbols are not used on nicotine-containing products.”

The TPD is silent on the marketing of e-cigarette devices that do not contain nicotine, so does not create any restrictions on the marketing or sale of these products, particularly to youth.  This is an important omission.  In contrast to cigarettes or conventional nicotine replacement therapies such as patch, gum, lozenge, there are many different e-cigarette-like products in the current marketplace and many are not sold pre-filled and pre-assembled.  (This situation also contrasts with the most similar medicinal product, the nicotine inhaler, which is standardized for use: It has only one cartridge of one nicotine concentration that only fits in one device.) With e-cigarette products, different components of products are sold separately and can be used with several different liquids with varying nicotine content. Indeed, one way that a company could possibly legally evade regulation under the TPD would be to sell nicotine-free e-cigarettes as consumer products then sell the nicotine fluid separately. It is not clear how the nicotine content standards would apply in this context (e.g., bottles of e-liquid, different sized cartridges that can be used on different devices). Moreover, it is not clear how every piece of these devices would be regulated to ensure that they meet safety standards (whether regulated a medicines or consumer products), or even if they would be allowed to be sold separately.

Perhaps most significantly, the amendments to the TPD adopted on October 8, 2013 eliminated the authority of the European Commission to update the regulations related to e-cigarettes as new information about marketing and use patterns and their direct health effects and effects on cigarette consumption develops in the currently rapidly changing market.  Specifically, the requirement that:
The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the requirements in paragraphs 3 and 4 taking into account scientific and market developments and to adopt and adapt the position, format, layout, design and rotation of the health warnings.
was deleted and replaced with a weak requirement for monitoring and preparation of a report after 5 years that could recommend changes to the TPD (but not make any actual changes). 

This change effectively insulates the e-cigarette companies from any science-based regulations for at least 5 years and likely much longer, since it moves the issue away from science and back into the political sphere where the tobacco companies are strongest.  (For illustrations of the tobacco industry's past influence on delaying the EU cigarette ad restrictions and the process of making regulations in the EU).

One can only speculate that tobacco interests were afraid of what the developing science will find about e-cigarettes, including further discrediting of the assumption that these amendments is based on.

This is not the final version of the TPD.  One can only hope that, as the TPD moves forward it will be amended again to be based on scientific evidence and not assumptions and rhetoric.



I am one of the MEPs who fought against medicines regulation of ecigs and for strong tobacco control measures in the TPD (feel free to consult my voting record).
I am very surprised to read your assertions that the lobbying on ecigs is somehow connected to the tobacco industry as that was not my experience. When I met tobacco companies/their proxies, with one exception they never mentioned ecigs, but focused on health warnings, packaging and the proposed bans on menthol and slims (all of which I support, so they were wasting their time!). The one exception was a tobacco company who said they supported medicines regulation for ecigs.
That made sense to me as tobacco companies have only started to enter the ecigs market in the last 9 months after realising the threat to their core business and they of course have the financial resources medicines regulation will require unlike the small and medium sized companies that currently make up most ecig producers.
So medicines regulation is a great way to hand the market to tobacco companies, which let's face it because of their core products do not really have an incentive to produce ecigs which are very effective at tempting smokers away from tobacco. In my view there is a danger that the ecig market gets severely squashed by medicines regulation including reduction in the number of products and companies in the market including products currently used by former smokers and making ecigs less widely available than tobacco in some EU countries This will be of great benefit to the tobacco industry and I am not minded to be kind to them.
The very strict advertising restrictions that the TPD currently places on ecigs, which you gloss over are primarily to prevent any attempts to market them at young people.
Your concern about flavours misses an important point: the flavours are one factor that encourages a former smoker to stick to ecigs after having switched and be less tempted to go back to the unpleasant taste of tobacco.
NB: In orders do be compliant with FCTC guidelines I have listed ALL my meetings on the tobacco directive on my website, all meetings took place in public, none were one-to-one (I was always accompanied by a staff member) and notes were taken to record the key points of each meeting.
Rebecca Taylor
Liberal Democrat MEP
Yorkshire and the Humber


The arguments MEP Taylor makes are fine in theory, but ignore the empirical evidence -- limited though it is -- about e-cigarettes:
<li;E-cigarettes do not help people quit smoking and may inhibit quitting.</li;
<li;There is no evidence that flavored cigarettes are used by adults; there is lots of evidence that they appeal to youth and young adults.</li;
<li;There is very high levels of dual use of e-cigarettes and conventional cigarettes in every study that has been done (all over the world).&nbsp; This dual use obviates most if not all of the "harm reduction" that might follow the fact that dual users smoke fewer conventional cigarettes.&nbsp; If someone is smoking even 1 or 2 cigarettes a day they suffer the full cardiovascular risk of smoking and most, if not all, of the lung cancer risk (since the <em;duration</em; of smoking is as important or maybe more important than the <em;intensity.</em;)</li;
<li;While the limitations on conventional advertising of e-cigs in the TPD are a good thing (as I noted in my post), most of the marketing is done through the internet and with viral marketing, which is essentially impossible to regulate.</li;
As for the tobacco companies' role, they are very well-practiced at staying out of sight.
There is a pattern of legislative efforts appearing all over the US with near identical terms and well-organized lobbying efforts to pass essentially the same kinds of policies embodied in the amendments to the EU TPD.&nbsp; The tobacco companies do their best to stay out of sight, but in http:// http://newsok.com/tobacco-bill-a-sign-that-oklahoma-lawmakers-had-reache... target="_blank";Oklahoma Reynolds American (which is 42% owned by BAT) was exposed, which helped kill their bill, at least for now.
In addition, however the market now exists, it, too, is rapidly being taken over by the cigarette companies.&nbsp; In 2012 and 2013 major tobacco companies – Lorillard, Reynolds American Inc, (which is 42% owned by British American Tobacco), Altria (Philip Morris), and British American Tobacco -- purchased or developed e-cigarette products. Lorillard, Reynolds and Altria's products are put forth by subsidiary companies: Lorillard Vapor Corporation, R.J.Reynolds Vapor Company, and Nu Mark, LLC. (owned by Altria). Lorillard acquired e-cigarette companies that produced Blu and SkyCig brands marketed under Lorillard Vapor Corporation. As of 2013, Altria’s Mark Ten e-cigarette is in test market in Indiana, Reynolds’ product, the Vuse, is in test market in Colorado and has planned to roll out national distribution and has created a TV commercial for the launch. BAT markets the Vype in the U.K. In addition, a smaller tobacco company, Swisher, that makes little cigars and cigarillos, also markets an e-cigarette called the e-Swisher.
There is no evidence that the cigarette companies are acquiring or producing e-cigarettes as part of a strategy to phase out regular cigarettes.&nbsp; Indeed, as noted in the 2010 Surgeon General’s Report, "How Tobacco Smoke Causes Disease," the tobacco industry has used every iteration of cigarette design to undermine cessation and prevention.
The tobacco companies are using their “smokers rights” activities - where they use seemingly independent groups to interact with consumers directly on political involvement in support of their agenda.&nbsp; Altria has a website called “Citizens for Tobacco Rights” and Reynolds has “Transforming Tobacco.” E-cigarette news and action alerts are featured on the homepages of these websites and include instructions for taking action against bills designed to include e-cigarette use in smokefree laws.&nbsp;
After evaluating the cigarette companies’ internal documents and public positions on snus as “harm reduction” in Europe, http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.... target="_blank";Peeters and Gilmore found that they were entering the market to protect their cigarette business as long as possible.&nbsp; They saw clear lessons for assessing the companies’ involvement in e-cigarettes:
While such evidence must be considered alongside the broader body of evidence around snus and the fact it is significantly less harmful than smoked tobacco, collectively these issues suggest that legalising snus sales in Europe may have considerably less benefit than envisaged and could have a number of harmful consequences. Perhaps of greater concern, however, given that harm reduction using nicotine products is already an established element of tobacco control and recent research suggests scope for benefit via newer nicotine products, are the recent industry investments in pure nicotine products. These raise two concerns. First, one of competition: should such investments continue, competition between cigarettes and clean nicotine products would decrease, limiting the potential for harm reduction to benefit public health and maintaining the status quo of cigarettes. While a nicotine regulatory authority could ensure that regulation was proportional to harm, it would be powerless to address the issue of competition, so this situation needs close observation. Second, they may enable TTCs [transnational tobacco companies], by presenting themselves as purveyors of nicotine rather than tobacco products, to undermine Article 5.3 of the Framework Convention on Tobacco Control which aims to protect public health policy from commercial and other vested interests of the tobacco industry. Finally, if TTCs are genuinely interested in seeing their cigarette consumers switch to snus (or pure nicotine products), rather than creating new snus/nicotine users and/or dual use opportunities, we would expect to see detailed strategic plans and cigarette sales reduction targets at least for the markets where they intend to introduce these products. However, to this date we have yet to see this. [citations eliminated]
Even iff if you accept what MEP Taylor is saying, the reality is that the science is rapidly accumulating, so it makes no sense to remove authority from the Commission to change the rules as more information becomes available.
An approach that would be more consistent with the EU's general embrace of the Precautionary Principle would be to adopt tight standards, then allow the flexibility to loosen them if new science becomes available that warrants doing so.


Please can you direct me to the evidence for your claim:
"If someone is smoking even 1 or 2 cigarettes a day they suffer the full cardiovascular risk of smoking and most, if not all, of the lung cancer risk."
Every study I've read which differentiates between light and heavy smokers, concludes that for a given duration, heavy smokers have a much higher risk of lung cancer. Indeed, the term "pack years" i.e amount multiplied by duration, was coined by tobacco harm researchers for this very reason.&nbsp;
Jonathan Bagley


Two (of the many) references that is useful are
Bjartveit, K. and A. Tverdal (2005). "Health consequences of smoking 1–4 cigarettes per day." http://tobaccocontrol.bmj.com/content/14/5/315.long" target="_blank";Tobacco Control <strong;14</strong;(5): 315-320.
Flanders WD, Lally CA, Zhu BP, Henley SJ, Thun MJ. Lung cancer mortality in relation to age, duration of smoking, and daily cigarette consumption: results from Cancer Prevention Study II.http://cancerres.aacrjournals.org/content/63/19/6556.long" target="_blank"; http://www.ncbi.nlm.nih.gov/pubmed?term=%20%20%20%20%20%20Targeting%20Ti... role="menuitem" title="Cancer research.";Cancer Res. 2003 Oct 1;63(19):6556-62.

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