The United States product legislation framework for electronic nicotine delivery systems (ENDS or e-cigarettes) is unusual in both its severity and its lack of nuance. This chapter argues that at present the framework is inadequate (as well as internally inconsistent) with respect to the protection of public health, because it does not differentiate ENDS from traditional cigarettes; does not acknowledge the risk differential between tobacco products and ENDS; and places a much higher - and economically unsustainable - regulatory burden on the fledgling ENDS industry than on the conventional cigarette industry. The chapter also analyzes an important court challenge against the Food and Drug Administration and ENDS regulation promulgated under the 2009 Family Smoking Prevention and Tobacco Control Act, and looks at legislative initiatives that arguably have sought to reach an optimal regulatory balance between the precautionary principle favoured by regulators and the true protection of public health. It is posited that attainment of such a balance could lead to support for reduced risk ENDS alternatives.
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