Action Alert: Don’t Add to FDA’s Burden by Asking it to Regulate Tobacco

Published February 1, 2008

Bills currently under discussion in Congress would require an already-overburdened Food and Drug Administration (FDA) to begin regulating tobacco products. Even worse, the proposals would prevent life-saving information on harm-reduction from reaching millions of nicotine-addicted Americans.

FDA’s excessive red tape application process and lengthy clinical trials already delay approval of life-saving pharmaceuticals. On average, it is 8.5 years before a new drug reaches the general market. FDA’s own Science Board recently reported the agency “is in a precarious position: The agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.”

If FDA is newly burdened with regulating tobacco, how much longer will Americans be forced to wait for the approval of life-saving drugs?

Even FDA Commissioner Dr. Andrew von Eschenbach, an oncologist, is skeptical of adding more responsibilities to his agency. He told the Associated Press, “We find ourselves in the conundrum of having made a decision about nicotine only to have made the public health radically worse. And that is not the position the FDA is in; we approve products that enhance health, not destroy it.”

The bills would effectively prohibit the makers of smokeless tobacco products from sharing with the public information about the relative risks of their products versus cigarettes. FDA would be forced to turn its back on a wealth of scientific research that confirms the life-saving harm-reduction benefits achieved when smokers switch to smokeless tobacco products.

Many of America’s 45 million smokers may be addicted to nicotine. Despite the constant drumbeat of anti-smoking messages, warning labels, and health education programs, most smokers do not choose to stop smoking cigarettes. Tobacco is a legal product and can be consumed in a variety of ways, some of which are safer than smoking.

Research available from The Heartland Institute and others shows smokeless tobacco is 98 percent safer than cigarettes. A wealth of peer-reviewed research generated in the past few decades domestically and abroad provides the basis for a simple, effective method of harm-reduction for these smokers: Switch from cigarettes to smokeless tobacco.

Tobacco harm-reduction is a science-based principle. No one–not Congress, not FDA–should do anything to interfere with consumer education on this topic.

For further information on FDA regulation of tobacco, see Heartland’s Research & Commentary: FDA Regulation of Tobacco at For more information on tobacco harm reduction, please visit the “Smoker’s Lounge” on The Heartland Institute’s Web site at

If you have additional questions, please contact Nick Baker, legislative specialist for The Heartland Institute, at 312/377-4000, [email protected].