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EU Commission Misunderstands Scientists

The reply that scientists received from the EU Commission, in response to their critique of the proposed Tobacco Products Directive (TPD), did not address the concerns they had raised, and included factual errors and unsupported assertions.

In no way was it an adequate reply to the important questions facing the regulatory authorities of the European Union. The scientists have replied to the letter with another critique, not only reasserting their claims, but also responding to the incorrect implication that they are in the pay of e-cig companies.

On January 17, a group of 15 scientists, from several EU and non-EU countries, whose work is in the field of electronic cigarettes, sent a letter jointly to the EU commission (later published in the journal New Scientist, pointing out the mistakes in the impending legislation described in the proposed TPD.

First of all, the EU commissioners misquoted research studies by Dr. Konstantinos Farsalinos, to the effect that 20 mg/ml of nicotine is the amount normally delivered by a single combustible cigarette, and used this incorrect data to establish a cap of that amount on permissible nicotine delivery by e-cigs. Dr. Farsalinos had already responded individually to this misinterpretation of his work. The joint letter points out that the correct figure is 50 mg/ml. Regarding the 20 mg/ml threshold, the Commission simply asserted that “ various studies - including from scientists that signed the letter - indicate that electronic cigarettes with such a nicotine threshold or below help the vast majority of smokers”, without any specific figures, attributions, or support.

Regarding the Commission's assertion that 60 mg of nicotine is a toxic dose, the scientists rejoined that it is more like 60 times that, and that ingestion of a toxic dose is impossible anyway since vomiting would begin long before toxic levels could be consumed. They also noted that far more dangerous chemicals are regularly kept in households (cleaning fluids and the like), and that children are adequately protected by child-proof caps, warning labels, and the expectation that adults in the household will behave responsibly. The reply said simply that “nicotine is not a harmless substance” and that it is currently defined as “toxic” under existing EU law. No mention is made of amounts, rendering the use of terms like “toxic” and “not harmless” senseless, and no documentation is given.

The scientists noted that the requirements of consistent dosage and information on nicotine uptake would impose costly requirements on manufacturers, with no benefit to users, since the product is used freely, with individual variation. The Commission's response simply reiterated the bogus claims.

The scientists pointed out that the requirement for small bottles of nicotine-containing liquid would be costly, and would impose a choking risk on children, in addition to being based on incorrect assumptions about toxicity. The Commission's response simply ignored this. The scientists had noted that no research substantiates the assumption that e-cigs are a gateway to smoking, but that in fact preliminary studies suggest the opposite. The Commission's reply simply reiterates the unsupported assumption of a need for “vigilance” to make sure that such a gateway does not become a reality.

Finally, the Commission implies that the scientists are in the pay of the vaping supplies industry. The new critique decisively refutes this unsupported implication, with individual disclaimers by each individual researcher, showing that nine of the 15 have received nothing whatever from e-cig manufacturers, one of them serves part-time as a consultant for an e-cig company, four of them have conducted studies partially funded by e-cig manufacturers, at institutions that pay their salaries from institutional funds not so supplied, and one of them has received travel funding for unpaid talks.

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