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The bill completely ties the hands of FDA in terms of complying with the very legislation that sets requirements for its action. The loopholes in the legislation are huge, and not only benefit the tobacco industry, but institutionalize tobacco and addiction to tobacco products in our society. The fatal flaw of the legislation is the unacceptable degree of restriction of FDA’s potential actions which makes it impossible for FDA to act appropriately within the legislative mandate it is given.

Tobacco companies will benefit from this bill because they will be able to use the fact of being regulated by FDA to achieve improved public opinion by taking advantage of the PUBLIC PERCEPTION that the tobacco problem is basically taken care of. The public’s perceived level of the health risk posed by ordinary tobacco products will decline as the public perceives the fact of FDA regulation as automatically meaning that the product must be reasonably safe, or at least safer.

There is strong evidence that the bill will actually result in increased deaths compared to no legislation at all, as the bill will:
make it virtually impossible to research, develop, introduce, and market new potentially less hazardous tobacco products;

undermine current and future litigation and the public health remedies that are likely to result from such litigation, as tobacco companies will be able to successfully use the argument that they are already thoroughly regulated; and
reduce the publics’ perception of the inherent harms of cigarettes.
Additionally, there are no documented mechanisms by which S2461 will save lives. Health groups supporting this legislation have not produced a single, solid evidence-based argument of how this bill will save lives.

Research has documented that the kinds of marketing restrictions imposed by the bill are not effective in reducing youth smoking, or even in reducing youth exposure to cigarette advertising. The more stringent of the advertising restrictions will certainly be challenged in court, and may be found to violate the First Amendment.

Performance standards and disclosure requirements of the bill will not improve the public’s health. It is simply not known which specific carcinogens of the 40+ carcinogens in tobacco smoke and which specific toxins of the 4000+ chemicals in tobacco smoke are responsible for what diseases, what quantities of these chemicals produce what effect, and what the effect of removing these chemicals will be.

The Modified Risk Product section of the bill would make it virtually impossible for modified risk products to enter the market, while at the same time, allowing reduced exposure products to essentially be falsely marketed as reduced risk products. In effect, it protects the existing high-risk products on the market and precludes any harm reduction approach to tobacco control. This bill will make the approval of modified risk products in the future nearly impossible.