FDA Is Right Agency to Regulate Tobacco Products

Washington, DC — Comments made today by Dr. Andrew von Eschenbach, Commissioner of the U.S. Food and Drug Administration (FDA), indicate a misunderstanding of pending legislation to grant the FDA authority over tobacco products.

In an interview with the Associated Press, Dr. von Eschenbach expressed concern that reducing nicotine levels in cigarettes could actually harm public health if smokers change their behavior to maintain nicotine levels. What Dr. von Eschenbach failed to note is that while the legislation allows the FDA to require reductions in nicotine levels, it does not require the FDA to take any action regarding nicotine levels.

What the legislation does is give the FDA broad authority to require changes in tobacco products, such as reduction or elimination of harmful ingredients or reduction of nicotine, if the agency determines based on the best available science that these steps would protect public health. Dr. von Eschenbach’s comments are based on a fundamental misunderstanding of what the legislation requires. It gives the FDA a broad mandate to require changes in tobacco products that the FDA concludes will save lives, the first time any federal agency has had such authority.

As important, the legislation would for the first time require the tobacco industry to disclose to the FDA the contents of tobacco products and research regarding health effects of these products. This information is essential to the FDA’s ability to make informed decisions and take effective action to reduce the death and disease caused by tobacco use. The FDA is the right agency to regulate tobacco products because it is the only agency with the appropriate scientific expertise, regulatory experience and consumer protection mandate to do the job effectively.

It is unacceptable that, despite the fact tobacco products kill more than 400,000 Americans every year, no federal agency today has effective authority to regulate what is in these products, how they are marketed or what is disclosed about them. The real problem isn’t how the FDA might regulate nicotine, but that tobacco companies can increase levels of nicotine in cigarettes, as recent studies show they have done, and make other changes without disclosing them and without regard for the impact on public health. The FDA legislation would put a public health agency in charge of these decisions rather than leaving consumers at the mercy of the tobacco industry.

In an interview with Bloomberg News, Dr. von Eschenbach also expressed concern that tobacco products cannot meet the standard of “safe and effective” that the FDA usually applies to products under its jurisdiction. Again, Dr. von Eschenbach is misinformed about the standards in the bill. The legislation recognizes that tobacco products are uniquely lethal and cannot be “safe and effective.” Instead of maintaining this status quo, the legislation requires the FDA to regulate tobacco products “to protect the public health” by taking action that will reduce the number of people who are sickened and killed by these products.

The FDA legislation gives the FDA the opportunity to save millions of lives. It is the only agency with the scientific expertise and regulatory experience to do the job well. The alternative is the status quo and that is unacceptable.