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FDA One Step Closer To Increased Tobacco Regulation

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WASHINGTON — Congress on Wednesday moved a step closer to handing the Food and Drug Administration broad new authority to regulate tobacco products, despite concerns voiced by many lawmakers that the agency cannot handle its current workload.

The House Energy and Commerce Committee voted 38-12 for legislation that would allow the FDA to reduce nicotine levels and require larger and more informative health warnings on cigarette packs. A Senate committee has already approved similar legislation.

Energy and Commerce Committee Republicans were divided on the legislation, with 11 voting for it. Those who opposed it said the agency has had enough trouble ensuring the safety of the nation's food supply and medicine.

"This legislation, if it becomes law, would require the FDA to take on a task that is enormous, complex and completely outside its regulatory experience," said Rep. Joe Barton, R-Texas, the ranking Republican on the committee. "It will almost necessitate a diversion from its core functions."

Barton said the Federal Trade Commission was better suited for the job.

But Rep. Henry Waxman, D-Calif., said the "unfortunate state of affairs" at the FDA did not mean the agency should ignore the harms of tobacco.

"It simply means that when we give the agency this additional responsibility, we also must give it the resources necessary to handle the job and to handle it well," Waxman said.

To address concerns about resources, the legislation calls for the assessment of user fees on tobacco companies. The assessments could initially generate $90 million this year. By 2018, that amount would increase to $755 million. Aides said the fees would be assessed based on market share.

Health groups have been highly supportive of the legislation.

"This bill will put a stop to decades of Big Tobacco marketing, aimed at addicting each new generation of young people to their deadly products," said Daniel Smith, president of the American Cancer Society Cancer Action Network.

More than 400,000 people die from smoking-related illnesses each year. Rep. Jane Harman, D-Calif., noted that both of her parents died from lung cancer, and she asked lawmakers to consider the financial toll that additional smokers generate when they come down with smoking-related illnesses.

Proponents say various aspects of the legislation would deter people from taking up cigarettes or from using cigarettes that they may view as less dangerous because of their labeling.

The legislation would ban candy-flavored cigarettes, which attract younger smokers. It would also prohibit terms such as "light" or "mild" which many consumers mistakenly believe means the products are safer.

The Bush administration has voiced qualms about giving the agency responsibility for tobacco regulation because some people could get a false sense of security about the safety of tobacco products.

For decades, the FDA said it lacked authority to regulate tobacco so long as cigarette makers did not claim that smoking provided health benefits. In 1996, it reversed course and cited new evidence that the industry intended its products to feed the nicotine habits of the roughly 45 million Americans who smoke.

Tobacco companies sued, and the case eventually landed in the Supreme Court. In 2000, the court ruled 5-4 that Congress did not authorize the FDA to regulate tobacco.

Some smaller tobacco manufacturers endorsed the legislation after it was amended so that they would have more time to meet new testing and reporting requirements.

The National Association of Convenience Stores also said it would no longer oppose the bill, though the trade group stopped short of endorsing it. Lawmakers amended the legislation so that retailers getting orders to stop selling tobacco because they illegally sold tobacco to minors could have the orders modified or terminated if it's determined they took effective steps to prevent such sales.

Also, some lawmakers representing districts with a strong tobacco farming presence voted for the bill after it was amended so that products containing foreign-grown tobacco would have to meet the same standards applied to domestically grown tobacco.