- FAMRI Center
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.