In recent years, the Food and Drug Administration (FDA) has asserted its right to regulate a number of nicotine-containing products by recognizing them as drugs or drug delivery systems under the Food, Drug, and Cosmetic Act. These products include "Favor Smokeless Cigarettes," a nicotine vapor inhaler,1(p12) and Nicorette, a nicotine-containing chewing gum.(p13)
A leading tobacco company recently introduced a new nicotine delivery device that circumvented FDA regulation by claiming that it was a cigarette.2 By definition, a cigarette is primarily a small quantity of fine tobacco rolled in paper (usually rice paper), cylindrical in shape, for smoking.1(p10) In contrast, this nicotine delivery device had the outer paper covering of a regular cigarette, but the cylinder was a metal chamber filled with pellets of alumina mixed with nicotine extracted from tobacco, a flavoring agent, and glycerol. Tobacco was not burned. Instead, when the device was ignited, a distal charcoal tip heated the glycerol, forming an aerosol that was inhaled by the user. The mouthpiece was made, in part, of tobacco leaves, and leaf tobacco was used to insulate the metal chamber, but these were never consumed.2
This product was intended to provide the user with the sensations and enjoyment of cigarettes without burning tobacco.1(p11-12) However, it was at least as effective as conventional cigarettes at delivering carbon monoxide and nicotine,2 a substance with well-recognized pharmacologic, toxic, and addictive properties.3-5
There is a potential market for this product of more than 50 million tobacco users who are addicted to nicotine. Most of these users would like to stop smoking or have tried to stop smoking,5 and they may erroneously perceive similar devices as safe alternatives to cigarettes.
- Copyright © 1991 by the American Academy of Pediatrics