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.
Coral Gartner and Marilyn Bromberg
This chapter describes the current regulation of Electronic Nicotine Delivery Systems (ENDS) in Australia. Australian federal, state, and territory governments have applied highly restrictive regulations to this category of products. ENDS that are supplied, possessed, or used for therapeutic purposes are classified as a prescription-only medicine and regulated by federal therapeutic goods regulations but no such products have yet been approved as medicines, and few options exist for legally accessing unapproved medicines. Nontherapeutic ENDS are classified under most regulations as dangerous poisons and require authorization for their supply, possession, or use. Most Australian ENDS users thus import and use nicotine-containing products illegally. The chapter also discusses regulatory actions in Australia against ENDS suppliers and users, and failed attempts to liberalize the regulation of ENDS.