Friday, July 05, 2013

Anti-Smoking Advocates Call FDA Action on Slightly Modified Cigarettes "Historic"; They are Correct, But Only for Historic Stupidity

According to FDA Commissioner Margaret Hamburg, the agency took a "historic" action last week that is going to reduce "preventable disease and death" due to tobacco.

Dr. Hamburg noted that the FDA is the only agency in the world that has these powers. And the Campaign for Tobacco-Free Kids also boasted of the historic nature of the FDA's action.


What was this historic action taken by the FDA which will prevent disease and death due to tobacco?

A. Implemented an anti-smoking media campaign in all 50 states at funding levels recommended by the CDC.

B. Banned the use of menthol flavoring in all cigarettes.

C. Mandated a reduction of nicotine levels in cigarettes to below a level capable of sustaining addiction.

D. Increased the age of sale for cigarettes to 21.

E. Restricted access to cigarettes to a prescription-only basis.

F. Required the reduction of formaldehyde, benzene, and nitrosamine levels to trace levels.

G. Made sure that a couple of cigarette brands that are essentially the same as existing brands and which confer essentially the same public health risk do not enter the market.

The Rest of the Story

Arguably, choices A-F are measures that truly would be historic and truly would prevent disease and death due to tobacco. On the other hand, measure G is the one action above that would be meaningless and do nothing to protect the public's health.

Sadly, if your answer was "G," you are correct.

We know that minor changes in cigarettes do not correspond to substantial differences in public health risk. In fact, whenever cigarette companies have suggested that this might be the case, they have been immediately accused of fraud and taken to the courtroom or ordered to stop making such inane and unsupported claims.

How things have changed! Now the FDA can make essentially the same claim - arguing that very minor changes in cigarettes can substantially alter the public health risk associated with these products - yet the agency gets away with the same fraud that the tobacco companies were not able to get away with.

I have to give Lorillard credit here because unlike the FDA or anti-smoking advocates, Lorillard refrained from making any insinuation that the company's compliance with this aspect of the FDA regulation is in any way protecting the public's health.

But not so for the anti-smoking groups, which proclaimed this to be a historic event that is going to save countless lives.

The Rest of the Story

In 2013, while the tobacco companies themselves acknowledge that all of their cigarettes are equally hazardous, the Campaign for Tobacco-Free Kids is telling the public that despite very slight differences in product design, brands of cigarettes that are not identical raise substantially different issues of public health. The Campaign is arguing that despite these very minor differences, cigarette brands that are not identical are substantially different in terms of the public health risk that they pose. Thus, the Campaign argues that minor changes in cigarettes can make these products substantially safer.

This is the opposite of the position that the Campaign and other anti-smoking groups have traditionally taken. Previously, when faced with drastic differences in product design (Winston had no additives; Accord involved no combustion), the anti-smoking groups argued that despite these drastic differences, the products were substantially equivalent with regards to the public's health.

Now, all of the sudden, even minor differences render cigarettes substantially different in terms of public health risk.

How did it come to be that major differences in cigarette design used to be of no substantial public health consequence, while today, even minor differences are of substantial public health consequence?

Quite simply, the difference is that in 2009, the Campaign for Tobacco-Free Kids and other anti-smoking groups were successful in convincing Congress to enact the Tobacco Act, and so those groups are now under pressure to make it seem like the Act is going to accomplish something in terms of public health protection. So those groups are trying to convince the public that by strictly regulating very minor changes in cigarettes, the FDA is providing enormous protection to the public's health.

In other words, the Campaign for Tobacco-Free Kids and other anti-smoking groups have reversed their public positions because it is now politically advantageous to make the opposite argument that they made previously.

One final point. Many seem to be proclaiming that by acting on these six applications, the FDA has broken the logjam. That's just not apparent to me. Acting on six out of more than 3,000 applications that have been pending for many months does not break the logjam. In my view, the FDA should simply approve the majority of these applications in the next few weeks and make it clear that minor changes in cigarettes do not render these cigarettes substantially different in terms of public health risk.

And then the agency should move on and actually do something to protect the public's health.

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