Electronic Cigarettes and the FDA

The US FDA has taken an interest in electronic cigarettes. They claim e-cigs are drug delivery systems and the liquid is a drug, thereby giving them jurisdiction over their sales and marketing. Since no electronic cigarette has been properly tested as a new drug delivery system, no applications for a new drug is on file and the fact that many marketers are making unproven claims about the health risks and benefits of electronic cigarettes, the FDA is concerned.

What started as a few seized imports from three Chinese manufacturers has turned into a lawsuit challenging the FDA's authority over E-Cigs. Until that lawsuit is settled, the FDA is reluctant to act to ban their sale.

But that did not stop the FDA from conducting a small study, using the products of the companies who are now suing them. The study was quick and incomplete, but the results said just about what everyone thought they would:

• the products contain nicotine, a known dangerously addictive drug,
• some tobacco-specific nitrosamines (TSNAs), cancer causing agents, were detected in tobacco flavored cartridges
• the devices delivered inconsistent nicotine dosages
• and the big WHAMY, one out of the 18 cartridges tested contained diethylene glycol, a dangerous poison used in antifreeze. (and also in tobacco production and more important to the probable cause of this samples contamination: plastics manufacturing in China.)

While it was not shown that the amount of TSNAs discovered were at levels any higher than any approved nicotine replacement device, or that electronic cigarettes posed more or less of a danger to health when compared to any product, the findings along with the diethylene glycol was a devastating blow to the industry's claims of "Safer, No Carcinogens, stop smoking, just nicotine and water vapor".

The FDA held a press briefing, issued a Consumer Update and sent out press releases all warning electronic cigarettes could be dangerous and were not proven to be safe or effective as a quit smoking device. As would be expected headlines and news stories full of "the same substance used in antifreeze" and "cancer causing agents found" started circulating the world.

While it seems the FDA is not arguing that electronic cigarettes are far better for you then real cigarettes, they are quick to point out that being safer than the worlds most dangerous product isn't saying much. Safer than cigarettes doesn't meet the safety standards of new drugs and until more testing is done, no one really knows how safe, or unsafe electronic cigarettes are.

For now the FDA is quiet, but once the lawsuit is settled they will no doubt be back at the heals of the electronic cigarette industry demanding testing and formal evaluation as a new drug device.