Why the FDA doesn't want to regulate tobacco

A proposed law that would give the FDA the authority to regulate tobacco products have garnered a wide degree of support -- including from Philip Morris, the world's largest tobacco company.

The Family Smoking Prevention and Tobacco Regulation Act would give the FDA the same authority to regulate tobacco products that it currently has to regulate foods, drugs and medical devices. This means that the FDA would be responsible for approving all new tobacco products (but not products already on the market) and for regulating the levels of harmful ingredients in tobacco products and smoke.

Cigarette smoke contains an estimated 4,000 chemicals, and more than 40 have been identified as carcinogens.

The act would also strengthen the health warnings on tobacco products and prohibit the use of false claims in marketing, including "light" and "low tar." It would place stricter restrictions on the advertising of tobacco products.

According to some critics, it is this last clause that has led Philip Morris to support the proposed law. "If you make it more difficult to communicate with smokers, and you have half the market, it results in the market share getting locked in," said John W. Singleton, director of communication for Reynolds American, Inc., the second largest tobacco company in the United States. "If you get locked in at 50 percent, that's pretty good. The bill gives Phillip Morris a competitive advantage."

Cigarette brands produced by Reynolds American subsidiaries include Camel, Kool, Pall Mall, Salem and Winston.

Philip Morris subsidiary Philip Morris USA is the largest tobacco producer in the United States, controlling 50 percent of the consumer market. Philip Morris brands include Marlboro, the most popular cigarette brand in the world.

According to Philip Morris USA President Howard Willard, the company supports the proposed law because FDA regulation of tobacco products has been called for by the U.S. Institute of Medicine.

Why would Big Tobacco support regulation of tobacco?
Rival tobacco companies are not the only ones skeptical of Philip Morris' motivations. According to Stanton A. Glantz, director of the Center for Tobacco Control Research and Education at the University of California-San Francisco, the company's support was one of the main factors that convinced him to oppose it.

"I remain skeptical of the bill, because it's basically going to benefit Philip Morris," Glantz said. "I think that the FDA should have control over tobacco, but not on terms that Philip Morris wrote. I think that the people who are supporting this bill will live to regret it."

The House version of the bill already has 200 sponsors, while the Senate version has 55. According to Mathew L. Myers, president of the nonprofit Campaign for Tobacco Free-Kids, more than 500 public advocacy groups are also supporting the proposed law.

Why the FDA doesn't want to regulate tobacco
But the call for FDA regulation is being vigorously opposed by the agency itself, which insists that it is ill-equipped to regulate tobacco products.

Because the FDA's role is to regulate products that are beneficial to public health, it cannot be asked to regulate products that are harmful, said FDA chief Dr. Andrew C. von Eschenbach. The act "would ask us to apply this [public health] framework to tobacco products that, when used as intended, produce disease rather than promote health. FDA cannot 'approve' a tobacco product in this context, because there is no scientific context to determine benefit to outweigh the numerous risks."

Giving tobacco products the seal of FDA approval might mislead consumers into thinking that those products are safe or even good for their health, von Eschenbach said. In addition, the agency does not have the financial or staff resources that would be required to regulate the giant tobacco industry.