Thursday, February 27, 2014

FDA Has Accomplished Nothing to Make Cigarettes Safer; Not Even Denying Substantial Equivalence Application

Earlier this week, I reported that for the first time ever, the FDA has disapproved a substantial equivalence application, thus resulting in the unprecedented effect of pulling four cigarette brands off the market (four varieties of Sutra Bidis). Of course, I sarcastically hailed this action as a real life saver: by assuring that consumers won't find the unredeemably hazardous Sutra Bidis next to their safe and approved Marlboros, the FDA has certainly gone out on a limb to protect the public's health.

Today, I report that even the FDA's own report boasting about this action was in error, and that in truth, this action did not result in taking these four brands off the market.

I was informed that the company which submitted the substantial equivalence application had actually pulled these four brands from the U.S. market several years ago. The reason that the company failed to respond to the FDA's request for more information regarding the substantial equivalence application was apparently because it had no intention of re-introducing these products in the U.S.

According to the FDA's statement: "This marks the first time that we have used our authority under the Tobacco Control Act to stop the continued sale and distribution of currently marketed tobacco products because they were not found “substantially equivalent” – and it is not an action we take lightly."

Well, apparently this is not the case. The "currently marketed tobacco product" was not actually currently being marketed. While the FDA may not have taken the action lightly, they probably should have, since the action was of no consequence whatsoever, as the brands had already been pulled from the market.

Perhaps this is what happens when it takes two and half years to make a ruling on a substantial equivalence application. By the time you make your ruling, the brands about which you are ruling no longer exist.

The Rest of the Story

On a more serious note, this story merely highlights the fact that the FDA has done literally nothing in the past five years of its jurisdiction over cigarettes to protect the safety of the nation's cigarette supply. The agency has done nothing about menthol. The agency has done nothing about nicotine. The agency has done nothing to make cigarettes safer by regulating carcinogen or chemical levels or additives. The agency has, in sum, done nothing at all to make cigarettes safer.

And ironically, the FDA has failed to take the one action it could have taken to make the tobacco products availalbe on the makret a lot safer: to embrace the concept of electronic cigarettes and to propose regulations that treat these products more leniently than tobacco cigarettes, in order to motivate smokers to move away from the more toxic cigarettes to the much safer fake ones.

In fact, the two actions the FDA has taken on electronic cigarettes are exactly the opposite: actions which would have protected the most toxic tobacco cigarettes from competition by the much safer electronic ones.

First, the FDA tried to ban all electronic cigarettes. Fortunately, that didn't work. However, the agency continues to discourage electronic cigarette use and continues to have misleading information about these products on its web site.

Second, the FDA apparently tried to regulate electronic cigarettes in a manner that was inappropriately stringent and ended up protecting, instead of threatening, cigarette sales. Apparently, the Office of Management and Budget caught the FDA on that one and threw the regulations back in their lap.

At this stage, I really have to question the wisdom of having given the FDA regulatory jurisdiction over tobacco products in the first place. It was a bad idea five years ago, but it is only getting worse as the agency botches it and takes exactly the wrong actions -- protecting cigarettes rather than protecting the public's health.

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