FDA May Get Tobacco Regulation Authority
WASHINGTON (Reuters Health) - Lawmakers on Capitol Hill have introduced new legislation that would give the Food and Drug Administration (FDA) the legal authority to regulate tobacco products.
The bill would grant the FDA the power to regulate nicotine as a drug and to control cigarettes as drug delivery devices. It would also set down in law current regulatory restrictions on sales of tobacco minors.
Tobacco is blamed for over 400,000 deaths each year in the United States. The Centers for Disease Control and Prevention has estimated that smoking related illnesses cost the economy more than $50 billion each year.
``The widespread use of tobacco is eating away at our society's physical and financial health. FDA regulation of tobacco will be the first, best step toward reducing our health care costs and saving thousands of lives,'' said Sen. Lincoln Chaffee (R-RI), one of the bill's sponsors.
The agency has been trying to gain the authority to regulate cigarettes since 1996, when President Clinton ordered the agency to write rules aimed at curbing teen smoking.
Last March, the Supreme Court in a 5-4 vote overturned FDA's rules, saying that Congress never intended to give the agency the power to regulate tobacco.
In that ruling, the Court held that FDA's responsibilities under the Food, Drugs, and Cosmetics Act would require it to ban cigarettes because they were clearly unsafe. The new legislation gives the agency explicit authority over tobacco in a way that would satisfy the Court's ruling.
The bill, which is co-sponsored by Sens. Tom Harkin (D-IA) and Robert Graham (D-FL) mirrors language that was introduced in the Senate just a week after the Court's ruling last year. Last year's bill ``stagnated in the highly partisan atmosphere of an election year,'' said Jeff Neal, a spokesman for Sen. Chaffee.
Jay Poole, a spokesman for Philip Morris Management Corp., told Reuters Health that the company supports FDA regulation of cigarettes. ``FDA regulation is an idea whose time has come,'' he said.
In light of ongoing lawsuits and damage rulings against tobacco companies, FDA control over cigarettes ``would provide a level of certainty (for growers and investors) as to what the industry will look like for a long time to come,'' he said. Philip Morris makes Marlboro cigarettes and other brands.
Former FDA commissioner Dr. David Kessler said in an interview that the company's support for government regulation of cigarettes proves ``that we are in a very different place today than we were just a few years ago. (The industry's) survival is at stake.''
After losing in the Supreme Court last year, ``we never thought that we would have at least some of the companies calling for regulation,'' said Kessler, now Dean of the Yale School of Medicine.