GlaxoSmithKline Plc (GSK) is pushing for more stringent regulation of electronic cigarettes, which compete with its Nicorette gum and other smoking cessation products, according to e mails from a company executive.
Europe should follow the lead of the U.K., which plans to require e cigarettes to be licensed as medicines much the way other nicotine replacement therapy products are, wrote Sophie Crousse, the Brussels based vice president of European public affairs for Glaxo s consumer health care division.
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We believe in responsible and proportionate regulation for all nicotine containing products as medicinal products, Crousse said in an e mail dated Oct. 30. The message and other documents were made public last week through a freedom of information request made to the health and consumer affairs division of the European Commission.
The commission is revising the Tobacco Products Directive to regulate products such as e cigarettes that don t contain tobacco, yet are linked to tobacco use. E cigarettes, which Euromonitor International Plc estimates will generate $7 billion in sales by the end of this year, compete with quit smoking products sold by pharmaceutical companies including Glaxo, Johnson & Johnson (JNJ) and Novartis AG.
Upcoming Vote
In December, representatives of European Union governments and the European Parliament reached an agreement that the strongest e cigarettes would need authorization as a medicine. This would apply to e cigarettes with a nicotine strength of more than 20 milligrams per milliliter. The European Parliament is scheduled to vote next week on the compromise accord.
Glaxo also sought assurances that the revised directive will apply to e cigarettes already on the market and ensure a ban on advertising, according to company comments included in a draft of Article 18 of the tobacco directive. British American Tobacco Plc this week started a digital and television advertising campaign for the Vype e cigarette brand.
Safety is our number one priority and we support the smoker s right to choose from a selection of products that have well established safety and efficacy profile in helping them quit smoking, Simon Steel, a spokesman for London based Glaxo, said in an e mailed statement. All nicotine containing products including e cigarettes should be reviewed and regulated to the same standard of safety.
Tobacco Smoke
J&J, which markets the Nicorette line of products in all markets outside the U.S., is also strongly in favor of regulating all non tobacco nicotine products, including e cigarettes, as medicines, Caroline Almeida, a spokeswoman for the New Brunswick, New Jersey based company, said in an e mailed statement.
This is the best way to ensure all non tobacco nicotine products are advancing public health by means of effective, high quality and safe products, Almeida said.
Novartis (NOVN), the Basel, Switzerland based company that markets Nicotinell gums, lozenges and patches, didn t immediately provide a comment.
Smoking, E Updated
The primary components of e cigarette cartridges and vapor are propylene glycol, glycerine and nicotine. Smokers are harmed by the deadly tar and toxins in tobacco smoke.
In the U.K., the Medicines and Healthcare products Regulatory Agency will require manufacturers to present data on the quality of their products, on how they deliver the addictive drug nicotine to the body and on how they compare with existing nicotine replacement products.
Research commissioned by the U.K. agency has shown that nicotine levels in some e cigarettes can be considerably different from the level stated on the label, according to Jeremy Mean, an official in the MHRA unit in charge of vigilance risk management of medicines.
To contact the reporter on this story Makiko Kitamura in London at mkitamura1
To contact the editor responsible for this story Phil Serafino at pserafino
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The interpretation of this data is crucial because a federal appeals court blocked the F.D.A. s first attempt to require graphic warning labels on the grounds that the agency had shown no persuasive evidence that the warnings were likely to reduce smoking rates.
Most experts agree that the biggest deterrent to smoking is raising the cost of cigarettes. As a result, whatever impact graphic warnings had after they were introduced in Canada in 2000 depends heavily on the cost of cigarettes in that period.
The new study, carried out by researchers from the University of Illinois at Chicago and the University of Waterloo in Canada, argues that the F.D.A. erred in calculating cigarette costs in Canada. Published this month, it says the F.D.A. used cigarette excise tax rates, which rose significantly during the decade, instead of the prices actually paid by consumers, which fell. According to the study, that caused the F.D.A. to overestimate the effect of prices and underestimate the effect of graphic warnings.
Citing several alleged flaws in the F.D.A. s analysis, the study concluded that the reduction in smoking attributable to Canada s warning labels was 33 times to 53 times larger than the F.D.A. s estimate. Had the United States adopted such labels in 2012, it said, the number of adult smokers would have fallen by 5.3 million to 8.6 million.
The Campaign for Tobacco Free Kids, an advocacy group that favors graphic warning labels, urged the F.D.A. to use the study and other scientific evidence to come back with a label proposal that would satisfy the courts. Stronger, graphic warnings could save lives.