E-cigs: Smoking cessation device or drug?

Electronic cigarettes, or e-cigs, are all the rage -- and the subject of raging controversy.

A lawsuit filed April 28 against the U.S. Food and Drug Administration by e-cig importers Smoking Everywhere and NJOY, whose shipments of e-cig imports were being held at the border, said their products should be classified as cigarettes, which at the time were not subject to regulation by the FDA.

On July 22, however, President Obama signed into law the Family Smoking Prevention and Tobacco Control Act of 2009, which allows regulation of various aspects of the tobacco industry but not the banning of tobacco or nicotine.

Now, whether e-cigs will fall under the category of a tobacco product subject to the stringent demands of tobacco's regulation or a drug (nicotine) -delivery device will determine what burden the e-cig market must shoulder in proving e-cigs are safe enough to be FDA-approved.

Regardless of e-cigs' yet-to-be-determined classification, e-cig opponents, such as Sen. Frank R. Lautenberg, D-N.J., say the products must be removed from the market pending FDA approval.

Proponents, such as Dr. Elizabeth Whelan, president of the American Council on Science and Health, a non-profit group that frequently defends industries against claims their products are unsafe or unhealthful, say the e-cigs should be tested, but meanwhile should remain on the market, as it is the smoke inhalation, not the nicotine delivery and consequent addiction, that causes cancer and other serious illnesses.

Regardless of how the e-cigs are to be classified, the Electronic Cigarette Association wants FDA testing, said former Rep. Matthew Salmon, R-Ariz., president of the Electronic Cigarette Association.

FDA spokesman Michael Levy said the agency conducted a test of two e-cig companies' products through Cedar Laboratory in St. Louis. The e-cig association said the tests were politically motivated, scant, not peer-reviewed and inconclusive.

Both sides said they want further e-cig testing with an eye toward approval by the FDA, but the matter seems to be at a standstill, with e-cig products waiting at the border and e-cig users running out of the supplies they say are the only products that actually work as a tobacco alternative.