Anti-Smoking Groups are Still Wildly Misinformed About Electronic Cigarettes

Although they have now been on the market for more than three years, many anti-smoking groups continue to be misinformed about these non-tobacco alternatives to cigarettes that have helped many smokers to quit.

Perhaps the best example of the misinformation that some of these groups are disseminating is the SmokeFree Vegas web site, which informs readers that electronic cigarettes are yet another Big Tobacco product designed to enable smokers to smoke in the presence of smoking bans.

According to the site: "Being that Big Tobacco is always finding loopholes to allow their products to stay on shelves, in the midst of the court’s decision there may already be a way for E-cigs to continue selling without FDA involvement. The grand majority of E-cigs are marketed as smoking alternatives – that is, products designed to be used where and when traditional cigarettes cannot; meaning that they serve the same purpose as a normal cigarette would."

The article then goes on to inform the public that if electronic cigarettes are marketing with a therapeutic claim, they will not be subject to any regulation:

"The potential loophole for E-cigs could apply to the companies that market their product as a therapeutic item rather than a recreational one. ... While recreational E-cig companies will now be required to adhere to FDA regulations and provide the government with lists of all chemicals and ingredients in their products, therapeutic E-cig makers wont have to abide by the same rules. Since all E-cigs function the same way (essentially), the only method by which the FDA will determine which products are therapeutic and which aren’t is by assessing their advertising. You can rest assured that this leaves plenty of room for legal ‘gray areas’ that most E-cig makers will try to use to convince the FDA that their product is, and always has been, therapeutic."

The Rest of the Story

This article couldn't be further from the truth. It is reporting the exact opposite of the facts.

First, electronic cigarettes are not a Big Tobacco ploy. They aren't manufactured, marketed, or distributed by tobacco companies at all. They are distributed by electronic cigarette companies, which are independent of the tobacco industry.

Second, marketing electronic cigarettes with a therapeutic claim is not a loophole that would allow an electronic cigarette company to avoid FDA regulation. Quite the opposite. Making a therapeutic claim would place electronic cigarettes squarely within the FDA's jurisdiction of the product as a drug-device combination under the Food, Drug, and Cosmetic Act, and therefore, would require the removal of the product from the market until the distributor conducts clinical trials to get the product approved as a safe and effective drug/device.

Most electronic cigarette companies are likely to avoid making therapeutic claims so that their products can be regulated under the less stringent Tobacco Act, rather than under the Food, Drug, and Cosmetic Act. Moreover, regulation of the product under FDCA would technically require the immediate removal of the product from the market, since if a company makes therapeutic claims, its product is an unapproved drug device combination and that company is subject to severe legal penalties in addition to withdrawal of its product from the market.

It's not difficult to get a story wrong, but it does seem unusual that so many anti-smoking groups are getting this one wrong. This suggests to me that it is more than just a multitude of innocent mistakes. Rather, I believe that these groups are ingrained with an underlying ideology that simply does not allow for the endorsement of a device that simulates smoking, no matter how many lives that device might save. Thus, their immediate impulse is to attack these devices, attack the tobacco industry for marketing these devices, and mix up the story as necessary to paint a picture that these devices are made by evil companies that are trying to pull one over on the public.

Ironically, the only deception of the public that is occurring or will occur from electronic cigarette companies is:

1) that they cannot tell the public the truth about the relative safety of these products compared to cigarettes because if they do so, the products are modified risk tobacco products and need pre-approval by the FDA; and

2) that they cannot market the products as helping smokers to quit - even though that is the precise purpose of the product - because doing so could be interpreted as a therapeutic claim and therefore place the product under FDA jurisdiction as a drug device combination under FDCA.