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Somebody goofed down under

In a gaffe that must have been embarrassing for the world's most anti-vaping land, somebody in the Australian bureaucracy called the Therapeutic Goods Administration approved three brands of e-cigarettes as "medical devices".

One of the registration documents carried the proviso: "to be used as a quit smoking aid." Deja vu city! Didn't the American Food and Drug Administration make the same boo-boo five years ago when they first tried to regulate e-cigs as medicines? In that keynote incident, the US courts stepped in and sided with NJOY and its cohorts, saying that vaping devices, as we now call them, are not medicines, and nobody is allowed to say what everybody knows to be true, that they DO help you quit smoking.

Since then a great deal of ink has been spilled over the issue. Britain's MHRA thinks the ARE medicines that can help with smoking cessation, therefore they are doing everything they can to keep them out of the hands of people who could benefit from them. The FDA and the EU have decided that they are tobacco products, and therefore are gearing up to institute similar restrictions. Australia has taken the hardest line, banning their sale with threats of dire reprisals.

So it was a gaffe indeed when somebody in the TGA took a look at them and decided that, well, yes, they very likely CAN help people quit smoking, therefore it might be a good idea to let smokers use them.

The Sydney-based company called "EVA natural" fielded the products, which included an "Electronic Vaporiser Kit", an "Evo Electronic Vaporiser Kit" and vaporiser kit cartridges for use with the kits. Two of them were approved by the errant TGA official on the same day they were received by the agency, and the third had to wait only a day for approval.

It took two months to uncover the error, but the TGA finally decided to review the products, whereupon EVA natural, apparently seeing the ominous handwriting on the wall, elected to withdraw them from the market.

It was the first e-cigarette ever to be included on the nation's Register of Therapeutic Goods, admitted an agency spokeswoman. "However," she added, "it was subsequently removed after it was identified that it had been self-listed inappropriately."

The question of smoking-cessation efficacy is a tortured one. A growing number of scientific studies are confirming what vapers passionately believe to be the obvious truth, that vaping devices DO help you quit. Studies that claim to show the opposite usually do so by crunching data in convoluted ways. Nonetheless, vaping opponents and their journalistic acolytes continue to ignore the studies that confirm efficacy, and proceed to repeat the litany that " there is not enough scientific evidence."

Medicalisation of vaping devices is a separate but related question. Some believe that, since they do help you quit, they do have medical value. Others note that, while this may be true, therapeutic certification poses such ominous hurdles that medicalisation will in effect keep the product out of the hands of potential users who could benefit. Not only that, but it will entangle the products in the tentacles of the pharmaceutical industry, which seems eager to suppress products that could compete with its own ineffective nicotine patches and gums.