Thursday, September 17, 2015

FDA Says Some Cigarettes are Safer than Others, But Not Electronic Cigarettes

In a guffaw of epic proportions, the FDA has essentially told the public that some cigarettes are safer than others. But even more preposterous than this is the fact that while the FDA views some cigarettes as being safer, it does not view e-cigarettes as being safer than tobacco cigarettes.

On Tuesday, the FDA ordered four cigarette brands - Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 - off the market because the agency believes that these products may be more detrimental to the public's health than other cigarettes on the market. Essentially, the FDA is saying that it believes some cigarette brands are more dangerous than others.

In its press release, the FDA states: "The scientific basis for these four decisions include a failure to demonstrate that increased yields of harmful or potentially harmful constituents, higher levels of menthol, and/or the addition of new ingredients in the currently marketed products when compared to the predicate products do not raise different questions of public health."

The FDA is basically arguing that different yields of harmful constituents and different levels of menthol or other ingredients in currently marketed tobacco cigarettes result in a significant difference in the safety of these products.

Ironically, while the FDA is challenging the long-held belief that there is no substantial difference in risk between different brands of cigarettes, it maintains that there is not sufficient evidence that electronic cigarettes, which contain no tobacco at all and involve no combustion - are safer than conventional cigarettes. This is despite the fact that electronic cigarettes have been documented to release aerosol that is free of hundreds of harmful and potentially harmful constituents that are present in tobacco smoke.

The Rest of the Story

How can it be that a tobacco cigarette which is essentially designed in the same way as all other brands on the market (i.e., it burns tobacco) and which may only contain one additional ingredient can possibly be safer than other brands, yet a product which is designed completely differently (i.e., it contains no tobacco and involves no combustion) and which is free of hundreds of hazardous tobacco smoke constituents is no safer than cigarettes?

It is a good thing for the Department of Justice that it already prosecuted the tobacco companies because if they tried the same thing today, they could no longer use the key argument than won that case: the fact that lower yields of tobacco smoke constituents do not translate into a safer product. After all, the tobacco industry correctly argued that its products that were labeled as "low-tar" or "lights" did have lower yields of tar and/or nicotine. The key to the government's argument was that differing yields of nicotine and tar are not important from a public health standpoint. The yields do not translate into differences in public health risk. There is no existing cigarette that is safer than other cigarettes.

By reversing this long-held belief, the FDA has destroyed the government' primary argument in the DOJ case. After all, the FDA is maintaining that differences in constituent yield do translate into differences in health risk.

This is not only incorrect, but it is a terrible message to send to the public. Combined with the FDA's message that e-cigarettes are no safer than tobacco cigarettes, this translates into a public health communications disaster.

The public is being told that slight differences in tobacco smoke constituents change the health risks of smoking, but that taking the tobacco out completely does not alter the health risks.

The absurdity and irony of this story did not escape the notice of Lane Filler of Newsday, who wrote a scathing piece which points out the damage being done by the FDA's action. He writes: "What message are people supposed to take from the decision by the federal Food and Drug Administration to ban the sale of certain new cigarette brands because they may be more dangerous than brands previously sold. Can the new brands kill people twice? Do knives occasionally shoot out of these smokes and plunge into shocked smokers' eyes?" ...

"Having the FDA pick and choose which cigarettes can legally be sold to smokers is like having the FDA determine which brands of rat poison can be sold as dietary supplements." ...

"I don't support a ban on cigarettes. But I do support a ban on the FDA approving of some cigarettes and not approving of others. You cannot smoke cigarettes safely. The federal government can ban cigarettes because they kill people, or it can stop having the FDA regulate them. What it can't reasonably do is draw these fine distinctions between different killer products, and in appearance give the government stamp of safety and approval to ones that may be a bit less deadly than others."

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