Landmark tobacco legislation 10 years in the making is close to becoming law, giving the Food and Drug Administration clear jurisdiction over tobacco products. Tobacco is widely blamed for causing 443,000 deaths a year in the United States.
President Obama, who has a history of being an occasional smoker, has expressed support for the bill. Once he signs it, the FDA will be authorized to regulate tobacco advertising and marketing and limit flavorings. But it won't be able to ban tobacco or the most popular flavoring, menthol, outright.
The Struggle For Regulation
In the mid-1990s, then-FDA commissioner David Kessler tried to claim power over tobacco. But in 2000, the Supreme Court said it would take an act of Congress to give FDA regulatory authority. Since then, legislators have been trying to do just that, without success.
Kessler says the new bill allows the FDA to reduce the number of people who smoke and gives the agency broad new powers.
"The legislation gives very strong controls to the FDA to regulate access, to regulate the product and to regulate advertising," he says. "The legislation was crafted in such a way that it creates a separate center within FDA and gives FDA resources. The tobacco industry ends up paying fees that, in 10 years, can end up being $600 million a year."
The bill puts tobacco regulation into the hands of new commissioner Margaret Hamburg. At her Senate confirmation hearing earlier this year, Hamburg said her agency can handle it.
"It has the scientific expertise, the regulatory experience and the public health mission to do so, and I think that if done successfully, we can reduce smoking and we can help make cigarettes less harmful."
A Wide Range Of Input
It's a good bill, says Steven Grossman, who has followed the FDA as a consultant to food and drug companies and who has worked on Capitol Hill.
"A lot of people have had an opportunity to suggest changes to make it better," he says. "There's been a lot of thinking by a lot of very smart people on how it could be meaningful and how it could make a difference. There's nothing slapdash about this."
The nation's biggest cigarette manufacturer, Philip Morris USA, followed construction of the bill closely. Philip Morris spokesperson Bob Phelps says the company recognizes that cigarettes can kill, and welcomes the new legislation.
"We believe that FDA regulation could provide clear guidelines and oversight of products that could potentially reduce the harm caused by smoking," he says.
But other tobacco manufacturers are not so happy. At the time the bill won its first committee vote, the No. 2 manufacturer, Lorillard, issued a statement saying that the company does not believe the FDA can handle tobacco regulations.
"Congress should not be burdening the FDA with a new responsibility over a multibillion-dollar industry when it is failing presently to preserve its core mission," the statement said.