Thursday, December 20, 2012

European Council Tobacco Product Directive Does Include a Ban on Electronic Cigarettes

According to the official Tobacco Product Directive released yesterday by the European Union, most electronic cigarettes will be banned and not allowed to enter the market unless and until extensive clinical trials are conducted and the products can be approved as pharmaceutical agents. Only electronic cigarettes with less than 2 mg of nicotine will be allowed. Since most electronic cigarette cartridges contain more than 2 mg of nicotine (and many users report that cartridges below this level are ineffective), this amounts to a de facto ban on electronic cigarettes.

The relevant text from the Directive (Article III, Section 18, Number 1) states as follows:

"The following nicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC:
(a) products with a nicotine level exceeding 2 mg per unit, or
(b) products with a nicotine concentration exceeding 4 mg per ml or
(c) products whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng of nicotine per ml."

Since electronic cigarettes were not authorized pursuant to Directive 2001/83/EC, they must be taken off the market and cannot enter the market unless they contain less than 2 mg per unit. Keep in mind that most electronic cigarette users start with cartridges that contain in the vicinity of 12 to 20 mg of nicotine. The implication of this policy is that electronic cigarettes will not remain available as an alternative to cigarettes for smokers who want to reduce their health risks.

The Rest of the Story

There are only two goals I can think of that would logically justify this policy of keeping a much safer alternative to cigarettes out of the possible access of smokers:

1. The goal of punishing smokers for having the desire to undertake the "act" of smoking by making sure that option is not available to them other than the real thing; and

2. The goal of  protecting pharmaceutical company profits by insulating them from competition from products that appear to be more effective than anything they currently have on the market.

If the goal were to protect the public's health by doing everything possible to get smokers off of cigarettes, then this policy failed miserably. In fact, it does just the opposite: it helps ensure that smokers will remain on cigarettes and that a significant proportion of them who would otherwise have been able to find an acceptable, safer substitute will no longer be able to do that and will instead remain on cigarettes.

The policy protects cigarette sales and pharmaceutical sales at the expense of the protection of the public's health. Essentially, the policy protects cigarette company and pharmaceutical company profits at the expense of the health of smokers.

The rest of the story is that because of this policy, the substantial decline in cigarette consumption that is predicted for the United States due to the widespread and rapidly growing popularity of electronic cigarettes will not occur in Europe. Now we have to hope that the FDA will not take any further actions to inhibit the ability of smokers to take advantage of this potentially life-saving innovation in the U.S.

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