E-Cigarettes and the FDA

December 21st, 2010 Leave a comment Go to comments


Judge rebukes the FDA from stopping imports

Since 2008 the e-cigarette or electronic cigarette, has been under fire from the FDA s. As e-cigarettes started spreading and gaining users in 2008, the FDA’s efforts to prevent e-cigarettes from entering the United States grew strong. To date, there have been approximately 50 shipments refused, but this has still not stopped the sale and distribution of the E-cigarettes. In March of 2009, Canada fully banned the use of these devices. The FDA has continued to issue warnings against the use of electronic cigarettes.

There are many different styles of e-cigarettes on the market today. However, all models are made of the same basic components and operate in the same general manner. Instead of tobacco, e-cigarettes are made of a rechargeable battery, circuitry, an atomizer and a cartridge or cartomizer that contains the e-liquid. The smoker inhales through the mouthpiece and the air intake triggers a flow switch that turns on the atomizer, which subsequently heats the e-liquid vaporizing it. Because there is no flame or fire involved in the process at all, many sellers are marketing electronic cigarettes as a safer alternative to conventional tobacco cigarettes, it does not mean these devices are healthier, as the FDA has yet to prove that. Opponents of e-cigarettes, such as the FDA, maintain that they are unsafe because some models have been found to contain cancer causing carcinogens and toxins.

The FDA has released these findings without sufficient testing though and may mislead the public into thinking that the electronic cigarette is as, or more dangerous than regular tobacco cigarettes. Proponents of e-cigarettes include health professionals, and they are weighing in on the issues concerning this alternative to conventional cigarettes. For instance, Dr. Elizabeth Whelan, president of the American Council on Science and Health, called the FDA’s recent statements “distorted, incomplete and misleading.” And Dr. Joel Nitzkin, MD, MPH, DPA, FACPM, Chair, Tobacco Control Task Force, American Association of Public Health Physicians stated that “we have every reason to believe the hazard posed by electronic cigarettes would be much lower than 1% of that posed by tobacco cigarettes. The testing guidelines in the current tobacco act, which is circulating through Congress, would represent a ban on electronic cigarettes, yet if we get all tobacco smokers to switch from regular cigarettes to electronic cigarettes, we would eventually reduce the US death toll from more than 400,000 a year to less than 4,000, maybe as low as 400.” It may be important to note that both Dr. Whelan and Dr. Nitzkin are anti-smoking advocates.

The sellers of electronic cigarettes have not kept silent in the face of the litigation. The CEO of NJOY, Jack Leadbeater, said in a recent statement, “NJOY has been tested by an independent third-party laboratory. This testing, as well as our consultation with medical experts, gives us confidence that our products are appropriate alternatives for traditional cigarettes for the committed smoker. We are therefore surprised the FDA’s testing has resulted in the agency suggesting that our products represent a health risk on par with conventional cigarettes. We will provide more information on NJOY’s testing and the results in the very near future.”

Smokers that are on the lookout for an alternative for traditional cigarettes will no doubt be eagerly awaiting the news reports of the ongoing litigation between the FDA and sellers of E-cigarettes.

But one thing is for sure, In  ruling for two companies who sued the FDA, U.S. District Judge Richard J. Leon determined that electronic cigarettes are tobacco products and are not subject to such restrictions.

“This case appears to be yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices,” Leon wrote in a 31-page opinion that granted the companies’ request for a temporary injunction against the FDA.

The judge called the FDA’s efforts a “tenacious drive to maximize its regulatory power.”

December 20th:

The agency on Monday filed a petition to ask the entire U.S. Court of Appeals for the District of Columbia Circuit to hold a new hearing and review the FDA’s appeal, which was rejected Dec. 7 by a three-judge panel.

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