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US and UK pharmaceutical licensing agencies both defeated

Discussion in 'Announcements and News' started by rolygate, Mar 10, 2011.

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  1. rolygate

    rolygate Forum Manager Verified Member ECF Veteran

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    Sep 24, 2009
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    7 December 2010: FDA again defeated in court. Three defeats in turn, including a 3-0 decision by the appeals court judges, and a defeat by the DC Court of Appeal, the second highest court of the USA, in their bid to have e-cigarettes classified as drugs.

    9 March 2011: MHRA announced withdrawal from their bid to do the same in the UK, by officially naming Option 3 - 'Do Nothing' as the result of their licensing notification MLX364.

    Celebrations are in order for the hundreds of thousands of lives that will be saved by these defeats of the pharmaceutical industry's agents. It's two down and one to go (the EU) in the fight for consumer rights and public health versus pharma industry income, in the three biggest arenas.

    The US decision cost two e-cigarette firms a great deal of money in legal fees. The result places e-cigarettes in the Tobacco Products class, and thus under FDA regulation as a consumer tobacco product. Inevitably this will mean added taxes (which is hard to argue against since the eventual loss of tobacco tax revenue will be substantial), and a campaign by the FDA to make them as unattractive as possible to the consumer - which will lead to many more battles between the industry and consumers versus a regulatory authority which is extremely close to the pharmaceutical industry and promotes its agenda whenever possible. The more unattractive smokeless tobacco products can be made, the more NRTs (quit smoking drugs) will be sold.

    The UK decision came principally as a result of the government changing. The new Con/Lib alliance, taking over from the Labour party, would have none of the socialists' 'control everything' policy that saw the UK become the world centre of CCTV population-watching cameras, and set up a watchdog with real teeth (the RPC), for a change, to stop the rot. The current UK situation seems happier in several ways as e-cigarettes are confirmed as still a consumer leisure product, not a tobacco product; and they are closely regulated by the Trading Standards authorities, who take samples for analysis. The MHRA have reserved their right to look at the issue again in Q2 2013 - but unless the EU decision is favorable to them, nothing else substantial will change.

    It remains to be seen which way the EU will jump, but with two decisions for consumer rights on the table it may be harder for them to go with the pharma agenda and ban e-cigs.
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