FDA to Regulate Roll Your Own Tobacco?

Source: Courier Journal

WASHINGTON — A bill giving the federal Food and Drug Administration the authority to regulate tobacco products appears headed for House passage.

By a vote of 38-12 yesterday, the House Energy and Commerce Committee approved the landmark legislation — the first time any House panel has voted for such a measure.

Eleven Republicans joined the committee’s Democrats in voting for the measure. Five of those lawmakers, including Rep. Baron Hill, D-9th District, Indiana, were from tobacco-producing districts.

With 220 co-sponsors from both parties and others who are now behind the bill, the legislation’s prospects are bright in the House.

A similar measure, with 56 co-sponsors, is awaiting action by the Senate.

Under the measure, the FDA would be empowered to require larger health warnings on cigarette packs, control tobacco company advertising and marketing, and order full disclosure of contents of tobacco products.

User fees imposed on tobacco companies would pay for the FDA’s regulation of the industry.

The legislation specifically bars the FDA from regulating tobacco farmers and does not allow the agency to ban tobacco.

The Bush administration, through FDA Commissioner Andrew von Eschenbach, has raised concerns that federal regulation of tobacco will be misinterpreted by the public as an endorsement of its use.

Parts of the proposed legislation would be difficult to implement, and Congress may not provide the agency with enough resources to do the job, according to Eschenbach.

White House spokesman Blair Jones said yesterday that the administration “believes tobacco is not a drug or device to be regulated by FDA,” adding that such authority is “inconsistent with FDA’s mission.”

However, an array of public health groups, religious organizations, unions, educational institutions and the AARP back the bill. The nation’s largest tobacco company, Philip Morris USA, and UST Inc., the largest maker of smokeless tobacco products, also support the measure.

The House committee’s action came as opposition ended from other groups — such as convenience store operators and some small tobacco companies, including the Louisville-based National Tobacco Co. — after lawmakers agreed to make changes in the bill.

“Regulating tobacco is the single most important thing we can do right now to curb the deadly toll of tobacco,” said Rep. Henry Waxman, D-Calif., chief sponsor of the bill. “And FDA is the right agency to do this job.”

But opponents said tobacco regulation will put additional burdens on the FDA, which they contended already is struggling to ensure the safety of food and drugs.

“This legislation, if it becomes law, would require the FDA to take on a task that’s enormous, complex and completely outside of its regulatory experience,” said Rep. Joe Barton of Texas, the committee’s ranking Republican.

Hill voted for the measure after the committee agreed to add language to the bill protecting domestic growers by barring foreign tobacco that does not meet federal chemical standards for American tobacco.

“This bill now strikes a careful balance between protecting the public and protecting the economic viability of tobacco growers,” said Hill, who is not one of the bill’s co-sponsors.

The lone Kentucky lawmaker on the panel, Rep. Ed Whitfield, R-1st District, voted against the bill, though he said he supported combating tobacco use.

“The FDA’s mission is to protect public health by assuring the safety and efficacy of our nation’s food and drugs — and tobacco is neither a food nor a drug,” Whitfield said in a statement. “Tobacco is a legal product that some people choose to use despite knowing the risks associated with it.”

Meanwhile, Rep. John Yarmuth, D-3rd District, said his concerns about the legislation were addressed when the panel agreed to give smaller tobacco companies up to four years to comply with some provisions and to join together to pay for testing products that may be required by the FDA.

Ron Tully, National Tobacco’s vice president of corporate affairs, said that without the changes the bill would threaten the survival of his firm and others of similar size.

National Tobacco has 300 employees — 200 of them in Louisville. The company makes cigarettes, smokeless tobacco and so-called “roll-your-own” products.

Rep. Michael Burgess, a Texas Republican who is an obstetrician, opposed the bill but offered an amendment that would have permitted a ban on tobacco or required the elimination of nicotine from tobacco products.

“This is an alternative to the scourge” of tobacco, he said. His amendment was defeated.

Waxman and other lawmakers said banning tobacco would backfire: it would fail to stop smoking and create a black market for cigarettes.

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