Ken Wassum, Senior Product Manager, Tobacco:

If anyone thought the controversy over the e-cig was going to quietly fade into obscurity, think again. On September 9, 2010 the FDA issued warning letters to five companies who manufacture or import the ecigs citing “violations of the Federal Food, Drug, and Cosmetic Act (FDCA) including unsubstantiated claims and poor manufacturing practices.”

The substance of the FDA’s action is that the companies have claimed their products can help smokers quit smoking. To do this the e-cig is supposed to deliver a dose of nicotine in a vapor. The problem is that this makes the product a drug delivery device. For a drug delivery device to be sold on the market it must be approved by the FDA, and without that approval, “a company cannot claim that its drug can treat or mitigate a disease, such as nicotine addiction, unless the drug’s safety and effectiveness have been proven.”

This is the step the manufacturers of the e-cig skipped -- proving that their product was safe. Early tests of two e-cig products showed they contained toxins. Now to be fair, I suspect they never intended to market it as an aid to quit smoking, but that is the message they are sending.  They are responding to the FDA saying their product is a tobacco product, not a drug delivery device. The problem is that cigarettes are the ultimate drug (nicotine) delivery device. Nothing has been developed that delivers nicotine faster or more effectively.

So is it a tobacco product or is it a nicotine delivery device? In the end, it really doesn’t matter. The role of the FDA is to regulate electronic cigarette and related products in a manner consistent with its mission of protecting the public health.  And a recent survey* showed the public agreed with them.  When asked if e-cig manufacturers should be required to test ecigs for safety, 91% said yes. Another 82% felt the FDA was doing its job in regulating ecigs like other nicotine-containing products.

Personally I am very glad the FDA is doing its job. If the products test as safe, then I have no problem with them being on the market. But if they are not safe, then they definitely should not be sold in the US.

* Survey of 2,064 adults conducted in May, with a margin of error of plus or minus 1 to 3 percentage points. Source: University of Michigan C.S. Mott Children's Hospital