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FDA and e-cigarettes – Backlog or snub?

On December 17th last year, the FDA held a consultation in which members of the public, as well as a medley of experts were allowed to submit testimony on e-cigs and smokeless tobacco products, two-thirds of whom were in the ‘pro’ camp. The consultation was also extended to online and written submittals, and an amazing 5366 responses were collected by the end of the period, the overwhelming majority of which were from electronic cigarette users.

Furthermore, a Whitehouse.gov petition gained 28,482 signatures in favour of preventing the FDA from banning or regulating the sale of e-cigarettes. At the time the petition was created, the rules dictated that a departmental response must be made if over 25k signatures were collected. None has been forthcoming, despite the petition ending over 6 weeks ago.

Currently, we are awaiting from the FDA a folio of 3 reports to congress, which will contain their plans to ‘deem’ electronic cigarettes as tobacco products. We now know that this has been delayed, and that they are “Currently, the Agency is still evaluating the data it has received from manufacturers, including verifying its accuracy”. The charitable interpretation is that they genuinely do wish to accurately report on the products.

However, It’s hard to be charitable with an agency that has both conducted in such clear obfuscation over e-cigarettes and reduced harm tobacco products in the past. And the complete lack of engagement with electronic cigarette users and independent advocates hardly inspires confidence in their desire to act impartially and with due process.

It’s my guess that the 5,300 or so submittals the FDA received in favour of electronic cigarettes have made continuing their obfuscation an impossible task, but one they’ll engage in nonetheless.

We await the reports and petition response with baited breath…

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