FDA Gains Regulatory Authority Over U.S. Tobacco

JULIE GALLAGHER

WASHINGTON — The U.S. Food and Drug Administration here assumed regulatory authority over the tobacco industry last week when President Obama signed The Family Smoking Prevention and Tobacco Control Act into law.

It requires that Health and Human Services Secretary Kathleen Sebelius establish a Center for Tobacco Products within the FDA and form a Tobacco Products Scientific Advisory Committee to provide advice, information and recommendations.

It will be tasked with examining the effects of altering nicotine levels in cigarettes, and determining whether there is a threshold level for dependence, among other things.

The new authority won't allow the FDA to ban nicotine in tobacco outright, but it can reduce nicotine levels; ban certain chemicals in cigarettes; and set limits on advertising and promotions, as well as require larger warning labels on cigarette packs.

It cannot ban all tobacco products or raise the national age to purchase tobacco products above 18.

Cost estimates for the center range from $85 million in the first year and as much as $700 million annually within 10 years, according to reports. Manufacturers and importers will foot the bill through quarterly user fees. They will be based on the tobacco product provided and company market share.

Philip Morris USA possesses more than half the share of the U.S. cigarette market.

Its parent company, Altria, supports government oversight on the condition that it's properly implemented.

“We have consistently advocated for federal regulation that recognizes the serious harm caused by tobacco products, that helps ensure tobacco companies do not market tobacco products to children and that also acknowledges that tobacco products are and should remain legal products for adults,” said Michael Szymanczyk, chairman and chief executive officer of Altria, in a prepared statement last week. “We believe a comprehensive regulatory framework, implemented thoughtfully, can provide significant benefits to adult consumers.”

Altria spokesman Bill Phelps said that it's too soon to tell what effect the change could have on retailers and their tobacco sales.

Others voiced concern that the authority will tax the FDA at a time when its resources are stretched to the limit.

Though the Grocery Manufacturers Association hasn't adopted a formal stance on the issue, President Pam Bailey is worried it could indirectly impact food marketers.

“I'm concerned that it has the potential, if not implemented appropriately, to distract the FDA from its ongoing responsibility,” Bailey told SN. “It's going to be a big challenge.”

Sebelius said that she's up to the task.

“HHS and its agencies are committed to working together to bring a creative, science-based approach to reduce the hazards of smoking and other tobacco use,” she said.