'One of the Worst Public Health Laws Ever Conceived'
As the Senate continues to debate a bill that would let the FDA regulate tobacco products, the American Enterprise Institute's John Calfee explains how it impedes competition between cigarettes and safer alternatives:
Congress is poised to pass one of the worst public health laws ever conceived….
Manufacturers would have to demonstrate that their products are not merely safer than some of the existing alternatives. They would have to demonstrate that once the products enter the market, they would not have undesirable second-order effects such as encouraging smokers to switch instead of quit, or encouraging non-smokers to start who otherwise would not have started.
Meeting this kind of standard would be extraordinarily difficult; it is nearly a recipe to discourage the development of almost any new product no matter how much safer it would be than what smokers now use. It moves the FDA far beyond the contours of drug regulation. Imagine that a dramatically effective new HIV drug could not be approved until the manufacturer demonstrated that the entry of the drug would not tempt some people into unsafe sex because they knew a better treatment could be used if worse came to worse. Suppose a better diabetes drug was kept on the sidelines while the manufacturer figured out how to show that the availability of the drug would not encourage obesity by discouraging weight loss and the like. No one wants the FDA to do that for drugs because we want better drugs, and we are willing to let consumers make their own decisions about how to revamp their lives accordingly. The imposition of this bizarre standard for new tobacco products reveals an intention to largely dispense with the task of reducing tobacco harm while demeaning the choices of smokers and potential smokers….
The same hostility to harm reduction infuses HR 1256's provisions on marketing….The most important information—about the product's risks and why it might be safer than something else—would be hemmed in by requirements of unknown rigor….There would be another beyond-FDA-drug-regulation requirement to demonstrate that if smokers are told about a safer product, they will not react by failing to quit smoking and so on. Again, one wonders about how the pharmaceutical market would work if heart drug manufacturers had to prove whether telling consumers how to reduce the risk of heart attacks would adversely affect their lifestyle choices about diet and exercise.
I discuss these and other problems with the Philip Morris Protection and Competition Control Act Family Smoking Prevention and Tobacco Control Act, which has been passed by the House and endorsed by President Obama, here, here, here, and here. As I said in a 2008 column, the central problem with this bill is that it seeks to prevent consumption rather than protect consumers, whose desires it aims to frustrate rather than satisfy.
