Electronic cigarettes Not FDA approved

In 2009, the FDA established the Family Smoking Prevention and Tobacco Control Act to regulate tobacco-related diseases. According to the FDA, tobacco-related deaths kill more than 440,000 people per year.

The FDA has been striving to categorize e-cigs as a “tobacco product” which will make them subject to registration, product, and ingredient listing, among many other requirements. They have said that laboratory analysis from e-cig samples showed the products contained carcinogens as well as toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.

After observing e-cig labels, the FDA concluded that cartridges claiming not to have nicotine actually do. The study also showed that similar e-cigs emit different varieties of nicotine.

Physcians fear the unknown about e-cigs.

“The e-cigarette is not regulated by the FDA,” said Medical Director Victor Marchione, M.D. of Liberty Health’s Smoking Cessation Program at Jersey
City Medical Center. “Therefore you don’t really know what the ingredients are. You may indeed be playing with fire. In the United States, tobacco is not considered a drug. Nicotine is an ingredient in tobacco. Therefore they don’t have any jurisdication to regulate the e-cigarette at this time. There’s no way to ascertain what nicotine level you are trying to achieve.”

E-cigs have malfunctioned at times, which also poses a safety concern. A Florida resident was one of the victims of a faulty battery that exploded while in his mouth, causing him to lose his teeth and part of his tongue.

“There have been cases where people have been scarred or burned on the face from the device which has disintegrated in their hand,” said Marchione. “I tell [patients] it’s a dangerous device until it’s FDA approved by U.S. standards. I don’t recommend it at this time.”

Marchione said many of his patients invest in e-cigs without researching the product.

“Since none of the e-cigarette products are currently regulated by the FDA, we really have no firm information about their safety,” said Dr. Michael Steinberg, from UMDNJ-Robert Wood Johnson Medical School’s Tobacco Dependence Program in New Brunswick. “We don’t know for sure what other chemicals are contained in the vapor, and how much nicotine is delivered. The perception is that since they don’t contain smoke, they are safe.”

He added, “If [manufacturers] demonstrate that e-cigarettes were safe and effective, they would likely be much more warmly embraced by the medical and public health communities.”

The UMDNJ- Tobacco Dependence Program is currently in the process of conducting a study comparing the use of e-cigs and nicotine replacement medications. The results of the study will be available soon.