Many Decisions Remain Over Tobacco Regulation

It's been 45 years since U.S. Surgeon General Luther Terry made what at the time was an earth-shaking announcement — that smoking causes cancer. That began decades of debate over tobacco and what the government should do about it that this week culminated in a new milestone: Congress passed legislation that gives the Food and Drug Administration the authority to regulate tobacco.

It's a bill that's been more than 10 years in the making — supported by Republicans and Democrats, President Obama and, more surprisingly, by the nation's largest tobacco company — Philip Morris.

Philip Morris worked with congressional staff and even some anti-tobacco activists to help write the bill. Bill Phelps, a spokesman for the company, says, "One of the strengths of this legislation is that it gives the FDA the authority to look at the research and evidence ... and use that information to make scientifically grounded decisions."

Some of those decisions will be about new tobacco products. Like the other big tobacco companies, Philip Morris has been working on smokeless tobacco products such as the Marlboro Snus. It's a small pouch of tobacco — sort of like a tiny teabag — that's placed in the mouth.

The tobacco companies say this new generation of products may be safer than cigarettes or conventional smokeless products — and they're hoping the FDA will back them up. "Our goal is to design the best products that we can and then, under federal authority, make them available to adults who do not quit," Phelps says.

Under current law, tobacco companies can't sell products as safer alternatives to smoking. As part of its new authority over tobacco, the FDA will evaluate new products and decide whether they can be marketed as presenting a reduced risk for smokers.

Matthew Myers of the Campaign for Tobacco-Free Kids says the intent of the bill and the FDA's mission is clear — to reduce the 400,000 deaths each year related to tobacco. "This legislation has the potential to produce the most fundamental change in how tobacco products are manufactured, marketed and sold in the United States," he says.

The legislation, which still needs to be signed by the president, allows the FDA to regulate all ingredients of tobacco products — including nicotine. But while the agency can order a reduction in nicotine, it can't force companies to remove it completely. And while most flavorings are banned by the bill, menthol, the flavoring used in a quarter of all cigarettes, is not.

Interestingly, after years of battling tobacco companies, Myers' group and others like the American Heart Association and the American Lung Association were allied with Philip Morris in pushing for passage of the bill. And some anti-smoking activists are now on the other side — criticizing what supporters are touting as "landmark" legislation.

One of the most vocal critics is Michael Siegel of Boston University School of Public Health. He says the bill has too many loopholes that limit the FDA's authority. The agency can't raise the legal age of sale of tobacco, restrict where it's sold or make it available by prescription only. It also can't act to totally remove tobacco's addictive component — nicotine.

"I would say if you're going to try to make this the first step to lead to bigger and better things in the future, then you need to not tie FDA's hands," Siegel says.

It's not just anti-tobacco activists who are split over the legislation. The measure has also divided the tobacco industry. No. 1 tobacco company Philip Morris wants it. But Nos. 2 and 3 — Reynolds and Lorillard — oppose it, in part because they believe it will prevent them from ever challenging the dominance of Philip Morris and its Marlboro brand.

The bill gives the FDA broad authority over marketing and immediately clamps down on the few advertising venues still available to tobacco companies.

Maura Payne, vice president of communications for Reynolds American, says, "As you limit even further companies' ability to talk to their customers, you potentially ... lock into place market share trends and sales trends."

Reynolds also worries that under FDA regulation, it will now be much more difficult to bring new tobacco products to market — products that could enable it to challenge Philip Morris.

Siegel has a different worry. "This bill is essentially going to give cigarettes an FDA seal of approval," he says. "If cigarettes are now under FDA jurisdiction, many people are now going to believe that cigarettes are somehow safer, that the problems are being taken care of. And unfortunately, that's just not the case."

With years of rule-making and assessments still ahead, it's difficult to predict how stringent the FDA's regulation of tobacco will be. That uncertainty is unsettling for many on both sides of the nation's tobacco debate.

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