US says electronic cigarettes must get government approval

September 9, 2010

So-called electronic cigarettes cannot be sold in the United States without getting regulatory approval, the Food and Drug Administration said Thursday.

The FDA sent a warning letter to five distributors of the product saying they have made "unsubstantiated claims" for the delivery devices and that the makers need to prove e-cigarettes are safe and effective.

Electronic cigarettes are battery-powered devices that have no tobacco but deliver a dose of nicotine to the user, while producing water vapor that looks like smoke. Used in a number of countries, they are promoted as a way to quit smoking.

The FDA said the devices deliver a drug and thus must get approval to show it is safe and effective and that the makers must demonstrate safeguards in the manufacturing process.

"FDA has determined that the electronic cigarette products addressed in the warning letters to the distributors, and similar products, are subject to FDA regulation as drugs," said the letters sent to the distributors.

Under US regulations, FDA said, "a company cannot claim that its drug can treat or mitigate a disease, such as , unless the drug's safety and effectiveness have been proven. Yet all five companies claim without FDA review of relevant evidence that the products help users quit ."

The agency sent warning letters to five distributors: E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America, E-Cig Technology Inc. and Johnson's Creek Enterprises LLC.

It also sent a letter to the Electronic Cigarette Association saying the agency "intends to regulate electronic cigarette and related products in a manner consistent with its mission of protecting the public health."

"FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed," said an FDA letter to the trade group for the industry.

The agency had previously warned consumers that many contained dangerous chemicals and it has taken steps to block the import of many such products.

The new warnings indicate a more aggressive position on e-cigarettes, which are intended as a replacement for cigarettes and cigars.

The association based in Washington could not be immediately reached for comment.

One of the distributors cited, Ryun America, no longer sells the product and does not intend to until regulatory issues are resolved, said company president Bill Bartkowski.

Explore further: FDA: Electronic cigarettes contain toxic chemicals

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2 / 5 (1) Sep 09, 2010
Great now the FDA can regulate something as a drug that is actually less dangerous than the cigarettes and alcohol they let you buy OTC.In my opinion the FDA needs to get off its power trip and allow people to have control over their bodies.
3 / 5 (2) Sep 09, 2010
In my opinion the FDA needs to get off its power trip and allow people to have control over their bodies.

On the other hand, people do live with other people in a society where their actions affect those around them. I also agree that we should let people have control over their own bodies, but bear in mind that if you are destroying your own health with an addiction you may be co-opting healthcare resources from the rest of society at some point.
3 / 5 (1) Sep 10, 2010
Real cigs should be banned (I'm a smoker, btw).
Electric cigarettes SHOULD be regulated, they should at least be tested for carcinogens. There are finally companies now that manufacture their "smoke juice" in the good old USA and they're FDA registered. Personally, I would much rather buy from them than order my e-cig refills from China. Who knows what the Chinese put in them, antifreeze maybe?

Think of the FDA regulation as the final step to e-cigs becoming LEGAL and SAFE. Once that happens, bye bye nasty tobacco smoke.

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