Tuesday, March 05, 2013

FDA's Disallowance of Smoking Cessation Claims for Electronic Cigarettes is Greatest Potential Cause of Use of These Products by Nonsmokers, Including Youth

There is a great irony in the way that the FDA and anti-smoking groups are treating electronic cigarettes.

On the one hand, the FDA and anti-smoking groups are warning us that because these products are marketed as alternatives to cigarette smoking, they may appeal to youth or adult nonsmokers and eventually lead to cigarette smoking initiation.

On the other hand, the FDA and anti-smoking groups are telling us that these products cannot be marketed for smoking cessation because the agency would treat that as a drug claim and take the product off the market under the provisions of the Food, Drug, and Cosmetic Act.

The Rest of the Story

In fact, the greatest threat that could lead nonsmokers to try electronic cigarettes comes not from the electronic cigarette companies, but from the FDA, CDC, and anti-smoking groups.

If the electronic cigarette companies had their way, they would market their products as devices for smoking cessation or smoking reduction. The only reason they are not doing this is the stated threat from the FDA to take their products off the market if they make smoking cessation claims. So instead of telling their consumers the truth - that these products are intended for smoking cessation/reduction - they are forced to essentially lie to the public and market them solely as an "alternative" to cigarettes.

But the great irony is that if electronic cigarettes were marketed as a smoking cessation or reduction device, then the potential threat that they would lead to smoking initiation among nonsmokers would be minimized. It is only because these companies are forced to market their products as an "alternative" to cigarette smoking that any potential appeal for the use of these products among nonsmokers remains.

So the irony is that by disallowing smoking cessation claims and forcing the electronic cigarette companies to instead market their products as "smoking alternatives," the FDA and anti-smoking groups are:

1. Essentially forcing the electronic cigarette companes to lie about the real purpose of these products;

2. Forcing the electronic cigarette companies not to be transparent with their customers and to deceive them about the real advantages of the product; and

3. Maximizing the possibility that nonsmokers may try these products, rather than minimizing it.

The most prudent public health approach would be for the FDA to explicitly allow electronic cigarette companies to tell the truth and to inform the consumer that the primary intended purpose of these products is to help smokers reduce or eliminate tobacco cigarette use, which will reduce their risk of disease. As I have explained, such a claim would not be a drug claim because smoking is a behavior, not a disease.

The rest of the story is that in their obsession over preventing electronic cigarette companies from truthfully telling their consumers that these products may be useful for, and are intended for, smoking reduction and cessation, the FDA and the anti-smoking groups are doing more harm than good. They are forcing the companies to lie to the public, maximizing the chances that nonsmokers may try these products, and inhibiting smokers from quitting.

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