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April,
2007

Tobacco Regulation Debate Heats Up:
FDA Commissioner Says Effort Could Backfire

As if there weren’t already a good deal of debate over the current Congressional bill to grant the U.S. Food and Drug Administration (FDA) regulatory authority over tobacco products, the FDA commissioner himself has jumped into the fray, but not in a manner advocates were expecting.

FDA head Andrew von Eschenbach says that allowing his agency to regulate tobacco products could inadvertently harm public health.

Appointed by President Bush and confirmed in December, Von Eschenbach said that smokers could increase cigarette consumption and inhale more deeply if the FDA reduced nicotine levels in cigarettes.

“We could 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 FDA is in; we approve products that enhance health, not destroy it,” said von Eschenbach.

The FDA first moved to regulate tobacco in 1996. But the Supreme Court ruled in 2000 that Congress had not authorized the agency to do so. Congress is currently considering legislation that would give the FDA the authority to adjust nicotine levels, among other powers. The question for advocates of the bill is whether adjusting nicotine levels saves lives.

“What I don’t want to see happen is that we are in a position where we are determining that a cigarette is safe,” von Eschenbach said. In general, he said, FDA doesn’t need more regulatory authority.

“The Bush administration has consistently undercut public health efforts to effectively regulate tobacco products and reduce youth smoking. In that context, this latest statement by an administration official is no surprise,” said Sen. Edward Kennedy (D-Mass.), co-author of the Family Smoking Prevention and Tobacco Control Act.

To Kennedy’s point, Neal Benowicz of the University of California at San Francisco points out a study by the National Cancer Institute (which von Eschenbach previously headed) finding that gradually reducing nicotine levels does not cause smokers to smoke more or inhale more deeply.

A bipartisan group of lawmakers introduced the legislation in February. It would grant the FDA authority over the manufacturing, marketing, and sale of tobacco products, including the power to restrict advertising, require stronger warning labels, and regulate the amount of nicotine and other ingredients. The agency would not be able to ban tobacco.

With one major exception, the tobacco industry has opposed the legislation. The exception is Philip Morris, the nation’s largest cigarette company, which could benefit if the Democrat-controlled Congress finally passes the bill. “Philip Morris USA believes regulation of tobacco products by the FDA would establish a comprehensive national tobacco policy that could potentially create a competitive framework within which manufacturers are focused on reducing the harm tobacco use causes. The company believes regulation would also bring predictability and clear standards to the tobacco industry in the United States.”

Despite advocate’s enthusiasm, Citigroup tobacco analyst Bonnie Herzog believes the chances of this bill passing this year is small. The debate rages on.

E. Edward Hoyt III