Five Manufacturers of E-Cigarettes Get FDA Warning

Drug safety laws have been violated by 5 firms that market e-cigarettes according to the FDA. The FDA has sent out warnings to all five firms. The companies that received FDA warning letters are:

• Cixi E-Cig Technology Inc. Ltd., Las Vegas, Nev.
• E-CigaretteDirect LLC, Parker, Colo.
• Gamucci America/Smokey Bayou Inc., Jacksonville, Fla.
• Johnson Creek Enterprises LLC, Johnson Creek, Wis.
• Ruyan America Inc., Minneapolis, Minn.

This is not an inclusive list, other companies are also marketing e-cigarettes in the U.S. Levy hinted that FDA concerns are not limited to the companies that today received warning letters, but said the FDA is not planning further actions.

Drug Safety Laws violated by E -Cigarette Manufacturers

Why all the fuss, what are these e-cigarettes or electronic cigarettes? They are tobacco free devices that usually look like a cigarette, pipe or cigar and the user gets a hit of nicotine filled vapor. Or even other substances. They are available in shopping malls or online. The FDA calls them unapproved drug delivery devices. They also say they cannot be legally sold until the device is proven safe.

Of course, the e-cigarette companies are fighting the FDA, and last year filed suits that blocked the FDA from banning the device.

The companies that have been given the warning letters must now demonstrate to the FDA that their products are safe and effective for their intended use. Also there must be steps in place that ensure the quality and purity of the products.

Manufacturers of E-Cigarettes must now demonstrate to the FDA product is safe and effective for intended use.

The original purpose of the e-cigarette was to help people quit smoking.

Some of the firms are being warned for the unsafe manufacturing of the device. Also for adulterated products, for containing ingredients or differing quantities of ingredients than what is listed on the product label.

Some of the E-Cigarette firms are being cited for unsafe manufacturing

The firm, Cixi E-Cig Technology, had very serious warnings sited against it. Their product contained unapproved drugs, such as rimonabant, a weight loss drug not approved in Europe or the United States. A second drug in the form of tadalafil, an erectile dysfunction drug was also discovered.

E-Cigarettes contain unapproved drugs and dangerous contaminants that can lead to fatal poisoning.

But even more alarming are the FDA tests that show the firms Vitamin C E-Liquid product contains DEG in dangerous quantities. DEG is a contaminant that the FDA warns can cause serious and even fatal poisoning.

In the warning letters sent to these manufacturing firms, the FDA said that the e-cigarettes met the legal definitions of both a drug and a device. Therefore they would require the FDA approval which would require that the companies conduct clinical trials, collect data and submit proof that the products are safe and that they are produced according to drug industry standards.

Needless to say any assistance to quit smoking would be welcomed by most people that are trying to break the addiction. But trading one addiction for another or even causing permanent and possibly fatal damage to oneself is not the answer.

Source:

WebMD