FDA Tobacco Science Panel Headed in Wrong Direction

Amy Ridenour’s Blog

The Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) has posted a draft summary of their report on dissolvable tobacco products.  The report is available for download here. The report was required by Congress and will be considered by the FDA is it evaluates how to regulate newer dissolvable tobacco products.

I attended portions of the meetings held in preparation for this report, and offered my comments as part of the open hearing. A video of my testimony is available here.  I am disappointed with TPSAC’s approach so far.  

The draft report fails to properly take into account the potential, as well as documented benefits of switching from the most harmful form of tobacco use, cigarette smoking, to lower-risk, but still not safe products, such as dissolvable tobacco and snus.

An examination of the beginning of the report makes the approach clear.

TPSAC considered the burden of tobacco‐related morbidity and premature mortality to be the appropriate indicator in addressing this element of its charge. That burden reflects the number of users of tobacco products, their patterns of use, and the risks of the products that they use, as set out in Figure 1.  


TPSAC lumps together all forms of “tobacco-related” effects, as if all forms of tobacco use were equally harmful. You might think that Figure 1 illustrates that “the risks of products they use” are different, but Figure 1 shows no such difference.

The report fails to appropriately acknowledge that cigarettes are by their nature more harmful than smokeless products, which are less dangerous because they are not burned and not inhaled.

The report gives little credence to the Swedish experience,
 as studied in published reports by University of Louisville’s Dr. Brad Rodu.  Dr. Rodu found that in Sweden, where snus replaced cigarette smoking, citizens suffered significantly fewer tobacco related diseases, including less oral cancer.

TPSAC writes that the Swedish tobacco harm reduction experience has “unique characteristics,” and therefore we shouldn’t place much weight on the very well-documented reduced rates of tobacco related illness, as the population began using snus rather than cigarettes.

Of course the experience in Sweden has “unique characteristics.” And Snus is different than the dissolvable tobacco products TPSAC is reporting on. But that doesn’t mean we can’t learn a tremendous amount from their experience.  And of course, some differences between Sweden and the U.S. suggest that we ought to be more like the Swedes. I doubt that many Swedes would have switched to snus if they were subjected to American-style scare campaigns; if they were, they’d  probably still be smoking cigarettes.

Furthermore, TPSAC makes the completely unfounded argument that
, “For health benefits to be obtained, complete substitution of snus for cigarettes was needed.” 

In plain english, that means, that TPSAC believes that in order for smokeless products to have any redeeming value to current smokers, anyone trying to switch must switch completely and never smoke even one cigarette again.

Consider: if you smoke ten cigarettes a day, and you substitute snus for five of those cigarettes, there would be zero benefit to your health, according to TPSAC. This is simply untrue. We know that the more cigarettes you smoke, the more you harm yourself. And while completely quitting all tobacco use is best, cutting your smoking in half, even with the help of smokeless products, would yield real health benefits. It’s too bad, for smokers, and those of us who have to pay for their health care, that TPSAC is unwilling to admit this.

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