5 facts about e-cigarettes – abc news
The decision in a 2011 federal court case gives the Food and Drug Administration the authority to regulate e smokes under existing tobacco laws rather than as a medication or medical device, presumably because they deliver nicotine, which is derived from tobacco. The agency has hinted it will begin to regulate e smokes as soon as this year but so far, the only action the agency has taken is issuing a letter in 2010 to electronic cigarette distributors warning them to cease making various unsubstantiated marketing claims.
For now, the devices remain uncontrolled by any governmental agency, a fact that worries experts like Erika Seward, the assistant vice president of national advocacy for the American Lung Association.
“With e cigarettes, we see a new product within the same industry tobacco using the same old tactics to glamorize their products,” she said. “They use candy and fruit flavors to hook kids, they make implied health claims to encourage smokers to switch to their product instead of quitting all together, and they sponsor research to use that as a front for their claims.”
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Thomas Kiklas, co owner of e cigarette maker inLife and co founder of the Tobacco Vapor Electronic Cigarette Association, countered that the device performs the same essential function as a tobacco cigarette but with far fewer toxins. He said he would welcome any independent study of the products to prove how safe they are compared to traditional smokes.
The number of e smokers is expected to quadruple in the next few years as smokers move away from the centuries old tobacco cigarette so there is certainly no lack of subjects,” he said.
E-cigarettes could become ‘medicines’ available on nhs
E cigarettes could be available on the NHS by the end of the year with at least two companies one a subsidiary of British American Tobacco having already embarked on the process of obtaining licences from the medicines regulator.
The UK company Nicolites said its application was “well advanced” while BAT’s Nicoventures has also started the process, although decisions on whether their products are prescribed on the NHS will be made by local commissioning groups.
The status of “medicines” will give the companies commercial advantage and allow the e cigarette makers to market their product internationally, including in sponsorship deals, a move that will be banned for competitors not in the same bracket.
The news came to light as ministers in England prepare to ban the sale of e cigarettes to under 18s Wales and Scotland are likely to follow suit.
The Committees of Advertising Practice are also about to launch a consultation on new rules to cover e cigarettes, used by 1.3 million people in Britain last year. It will start later this month, with the framework likely to be in place by autumn, nearly two years after the first TV adverts for such products.
The applications to the Medicines and Healthcare Regulatory Authority are a victory for the regulator’s determination to persuade manufacturers and importers to apply voluntarily for a licence and meet specific rules including on the amount of nicotine provided. They are continuing the process even though the European parliament defeated UK attempts to make medicinal licensing compulsory for e cigarettes last autumn,.
Existing anti smoking therapies such as gums, patches, an inhaler, and a mouthspray already have medicine licences and have been endorsed by the National Institute for Health and Clinical Excellence, which advises on good practice and value for money. Nearly 1.4m prescriptions for them were issued in England in 2012, but licensed e cigarettes would not need a separate Nice assessment.
Nikhil Nathwani, managing director of Nicolites, said the company was “well advanced in the product’s licencing” and hoped to achieve marketing authorisation some time this year. It was working closely with the government, the regulator and Nice. “This will be continued even after marketing authorisation has been achieved”, he said. Nicoventures has also made a licence application for a nicotine inhalation device to the MHRA.
A spokesman for BAT, which already has a standard e cigarette brand, Vype, on sale in Britain, said the company would like to see “a regulatory approach that puts consumer safety and product quality first, while allowing the appropriate level of innovation, marketing and distribution freedoms to allow this important new product category to grow.”
A spokesperson for Njoy, a big US cigarette company, which has also endorsed MHRA regulation, could not say whether an application was in progress, when contacted.
The readiness of big e cigarette players to go down the voluntary route for the expensive process of medicines approval is in sharp contrast to the position of the UK trade body for e cigarettes, Ecita, which has railed against the over regulation it claims will be introduced EU wide.
E cigarettes classed only as consumer products from 2016 will have to carry health warnings that nicotine is highly addictive. The draft EU directive, which has still to complete its legislative process in the coming months also contains new curbs on tobacco including health warnings covering nearly two thirds of cigarette packs.
This article was amended on 3 February 2014 because it is the Committees of Advertising Practice who are launching a consultation on new rules to cover advertising e cigarettes, not the Advertising Standards Agency as the original said.