More than ten years have passed since the adoption of the first Tobacco Products Directive (TPD) by the European Commission, thus making an update is clearly eminent in order to bring it in line with market, scientific and international developments in the tobacco sector. The Council and European Parliament have also repeatedly called on the Commission to address the weaknesses, gaps and loopholes in the existing rules but the latest version of this Directive has been contested by fifteen leading scientists who have investigated the health consequences of electronic cigarettes. The scientists say the EU’s aim is to draft an unjustifiably burdensome new law to regulate e-cigarettes.

TPD regulations on ecigs On January 17, a group of 15 scientists, from several EU and non-EU countries, sent a joint letter to the EU commission (later published in the journal New Scientist), pointing out the mistakes in the impending legislation described in the proposed TPD. They fear that if the newly amended Directive becomes law as it stands – which could happen as soon as April 2014– it will drastically limit the purpose for smokers of traditional cigarettes to give up or cut down by making the switch to e-cigarettes, which do contain nicotine but none of the tar and thousands of other substances potentially hazardous to human health. Smoking currently kills more than 700,000 Europeans each year.

First of all, the draft would restrict content to 20 milligrams of nicotine per milliliter of fluid, on the grounds that research studies by Dr. Konstantinos Farsalinos show this amount of nicotine as the amount normally delivered by a single combustible cigarette. The EU’s current assumption that 60 milligrams of nicotine is lethal for humans is incorrect, according to the scientists, and dates from self-experiments reported in a pharmacology textbook published in 1856. “This is not the case, and people have ingested doses 60 times higher, which only led to nausea and vomiting,” As the vomiting would begin long before a lethal dose could be ingested by vaping, it would be impossible for a vaper to inhale a deadly amount of nicotine.

Another argument with the current draft of the Tobacco Products Directive is its insistence that electronic cigarettes deliver nicotine doses “consistently”.  The scientist addressed this matter also in their letter accordingly: “The medicinal concept of ‘consistent delivery’ is inappropriate for a consumer product used freely. Users of cigarettes, oral tobacco and e-cigarettes spontaneously determine their nicotine intake according to individual and momentary needs. Individual users of the same electronic cigarette differ in their nicotine intake 20-fold. Quality control of individual brands is needed to ensure consistency of nicotine content but ensuring consistent delivery makes little sense. No such demands have been placed on tobacco cigarettes or oral tobacco.”

Other requirements of the Directive like the one on ‘Electronic Cigarette Manufacturers to Provide Data on Nicotine Absorption from Each Product’, or ‘To Limit Electronic Cigarette Refill Containers To 10ml And Tanks To 2ml’ have also been addressed and clarified by the scientists in their letter.

The last matter addressed was the highly debated idea that e-cigarette are a gateway to smoking. “Existing data do not suggest that electronic cigarettes are having any such effects,” they asserted. The only gateway effect is out of tobacco use.