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April 24, 2014

The Rest of the Story: Tobacco News Analysis and Commentary: FDA’s Proposed Electronic Cigarette Deeming Regulations: The Good, the Bad, and the Ugly

[As I posted on Sunday, the FDA is going take about 18 months to get its ducks in a row in order to tackle this issue. The Deeming Regs are not anywhere near formalized yet. If they go into the deep deep waters of reviewing every single e-liquid and every nic level, the paperwork-nado will be astounding and unmanageable for their current budget. If they include the vaping devices themselves, they will treble their work. As much trash talk the FDA has received over this, they are in a difficult position. They are not ignoring the fiscal impact of their decisions-not just for their own budget, but for the GAO and other agencies.]

Overall SummaryAll in all, the deeming regulations are a disaster. However, they are not as much of a disaster as they could have been. The positive side is that internet sales, marketing to adult consumers, and flavors are still allowed and that no products will immediately be taken off the market. The negative side is that new products will require pre-approval, virtually every product on the market will require a substantial equivalence determination if not a new product approval, and that manufacturers will be forced to implicitly lie about the intended purpose and relative safety of the product by not being allowed to correctly point out that these products are much safer than tobacco cigarettes.At the end of the day, while there are some positive aspects to these regulations, it is clear that science is not playing much of a role in the process. That does not bode well for the potential of electronic cigarettes to seriously challenge the combustible tobacco market, and thus to save hundreds of thousands of lives.

via The Rest of the Story: Tobacco News Analysis and Commentary: FDA’s Proposed Electronic Cigarette Deeming Regulations: The Good, the Bad, and the Ugly.

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