Should FDA Regulate Tobacco Products?

Published June 20, 2007

Proposals to give the Food and Drug Administration (FDA) regulatory control over tobacco are getting a serious hearing in Washington these days. The Family Smoking Prevention and Tobacco Control Act, sponsored by Sen. Edward M. Kennedy (D-MA) and Rep. Henry Waxman (D-CA), would impose new restrictions on tobacco product advertisements and sponsorship of public events and bestow on FDA new power to regulate ingredients found in tobacco products, including nicotine levels.

Legislation is necessary if FDA is to regulate tobacco, since in 2000, the U.S. Supreme Court ruled FDA lacks authority to regulate tobacco. FDA’s main concerns are keeping America’s food and prescription drugs safe. Tobacco is not a “drug” (for FDA regulatory purposes) as it offers no therapeutic benefits, nor is tobacco a food product.

There are many problems with the idea of FDA regulation of tobacco. FDA Commissioner Andrew von Eschenbach, concerned that under the proposal FDA would have the power to tamper with nicotine levels in cigarettes, does not think FDA should regulate tobacco. He has warned that a reduction in nicotine could lead consumers to smoke more cigarettes or inhale more deeply in order to achieve the level of nicotine they’re accustomed to.

The Kennedy-Waxman bill also prohibits claims about relative risk across tobacco products. Many relative risk studies have shown smokeless tobacco is safer than cigarettes. FDA regulation would prevent smokeless tobacco companies from advertising this information to consumers. It seems counterintuitive to approve a measure that would prevent consumers from making informed decisions.

Tobacco remains a legal product, even as we gradually restrict the areas where smokers can enjoy it. Adult consumers have the right to purchase and use it as they see fit. But the FDA, whose mission is to promote public health, would have to support future legislation in Congress to ban tobacco products altogether.

Most Americans don’t support an outright ban on smoking, and smokers would probably be furious with Congressmen who voted for such a ban. But Congressmen who vote for FDA authority to regulate tobacco are essentially endorsing a nationwide ban through the regulatory back door.

There is also the matter of whether FDA has the resources or expertise to take on new responsibilities. Recent headlines document the agency’s failures to protect consumers from tainted spinach and pet food. Likewise, FDA has come under withering attack for delaying the approval of new life-saving drugs.

Even minor delays in new-drug approval cost lives and unnecessary suffering, yet it takes FDA more than eight years to approve a new drug. In an era when biotechnology and other scientific advancements are leading to medical breakthroughs at an unprecedented rate, that is an unconscionably long delay. How much longer might it become if FDA becomes embroiled in a national campaign to ban smoking?

Tobacco is neither healthy for smokers nor pleasant to be around for nonsmokers. But allowing FDA to regulate tobacco isn’t the way to go.

Erin S. Murphy ([email protected]) is a legislative specialist for The Heartland Institute.