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.
“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.
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.”
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.
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.
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