E-cigarette or drug-delivery device? Regulating novel nicotine products.

n engl j med 365;3 nejm.org july 21, 2011 193 as drug-delivery devices. Previously, products delivering refined nicotine had either been regulated as pharmaceuticals (and subjected to the “safe and effective” standard used in drug approvals) or swiftly removed from the market to protect public safety. The FDA’s decision came after the courts blocked the agency from regulating these products as drugdelivery devices, holding that under the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA), products containing nicotine derived from tobacco but making no therapeutic claims must be regulated as “tobacco products.”1 Together, this ruling and the FDA’s announcement have upended the status quo. Unless and until the FDA asserts its authority under the FSPTCA, manufacturers can sell concentrated nicotine products directly to consumers, raising serious safety concerns. Nicotine, an alkaloid found in tobacco, acts as an agonist of nicotinic acetylcholine receptors in the peripheral and central nervous systems. A stimulant and the addictive drug in tobacco products, nicotine drives those products’ chronic use despite their well-known adverse health effects. Cigarettes typically contain 1 to 2 mg of nicotine, but nicotine has substantial toxic effects at higher doses. The estimated lethal dose for a child is 10 mg, the content of about half a pack of cigarettes. Smoking tobacco leads to nicotine deposition in the alveoli, absorption into the arterial circulation, and delivery to the brain within seconds. Such instant gratification makes cigarettes the most addictive drug of abuse, with tobacco eclipsing cocaine and heroin in terms of users’ reported difficulty in abstaining. The misleading term “e-cigarette” refers to an aerosolizing delivery device mated with a disposable cartridge. The cartridge contains nicotine in solution in a humectant, usually propylene glycol. The devices vary in construction, generally consisting of a battery, a heating element, a power source, and a pressure switch, all embedded in a tube with a mouthE-Cigarette or Drug-Delivery Device? Regulating Novel Nicotine Products