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The core ethical principle of transparency was spelled out in a Tobacco Control (see Fox BJ. Framing tobacco control efforts within an ethical context. Tobacco Control 2005;14[Suppl II]:ii38-ii44).

• The truth is that there is abundant evidence that electronic cigarettes are much safer than regular cigarettes. Even the tobacco industry itself acknowledges that smoking is more hazardous than vaping.

While it is theoretically possible that an electronic cigarette company could some day get a full reduced risk claim approved, the regulatory burden is extreme. Not only would the company have to show that the product is safer than smoking, but the company would also have to demonstrate that the product will not deter smokers from quitting and will not introduce youth to the use of nicotine. The studies required would be substantial. For most companies, the costs would be prohibitive. It would take many years before any company could even have a reasonable chance of getting such an application approved and by then it will be too late for the market to continue to expand.

The authors write: "FDA should immediately under the current rulemaking establish a product standard prohibiting flavors in e-cigarettes... ."


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