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Congress debates role of FDA in tobacco regulation

By TIM THORNBERRY
Kentucky Correspondent

WASHINGTON, D.C. — The idea that the Food and Drug Administration would take on the regulation of tobacco seems more likely than ever to become law as debates heat up in Congress.

Both the House and Senate introduced bills earlier this year that would essentially give the FDA the same regulatory power over tobacco products as it has over nearly anything consumable made in this country. However, with the exception of tobacco giant Philip Morris, most cigarette manufacturers are against the legislation.
For those in the tobacco industry, scenes from a decade ago are still vivid, with tobacco warehouses and farm fences throughout tobacco-producing states touting signs that read “Keep the FDA Off the Farm.”

The pending legislation is not about the farm so much as the manufacturers. Both House and Senate bills contain similar regulatory language seeking: “to ensure that the Food and Drug Administration has the authority to address issues of particular concern to public health officials, especially the use of tobacco by young people and dependence on tobacco; to authorize the Food and Drug Administration to set national standards controlling the manufacture of tobacco products and the identity, public disclosure and amount of ingredients used in such products; to provide new and flexible enforcement authority to ensure that there is effective oversight of the tobacco industry’s efforts to develop, introduce and promote less harmful tobacco products; to vest the Food and Drug Administration with the authority to regulate the levels of tar, nicotine and other harmful components of tobacco products.”

The lengthy bill contains more than 25,000 words of proposed regulations, including the authority to revise smokeless tobacco product warning statements.

Sen. Edward Kennedy (D-Mass.), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, is the main sponsor of S.B. 625. Not everyone on the committee agrees with him, including the committee’s ranking member, Sen. Mike Enzi (R-Wyo.), who said wording that had been changed since the bill was introduced will create a public health disaster and doesn’t “win the war on tobacco.

“Tobacco is one of the biggest contributors to our nation’s growing health care crisis. We need to address this issue head on, not sign a peace treaty with the companies who perpetuate and profit from the crisis,” Enzi said.

“Big Tobacco supports this bill because they have a stake in maintaining the status quo; I don’t. They’re happy with a bill that doesn’t stop people from smoking; I’m not.

“I want real change. We can and we must do better than this bill.”
Craig Orfield, a spokesman for Enzi, said the senator does not think an agency that helps regulate the safety of products consumed in the United States should be regulating something considered to be dangerous to the public health.

“(Enzi) does not want the FDA to regulate a product that is inherently dangerous. He is dead set against the Kennedy Bill,” said Orfield.

And the Big Tobacco Enzi referred to doesn’t reflect the opinion of other cigarette manufacturers.

Steve Kottak, director of communications for Reynolds American, Inc. (parent company of R.J. Reynolds), said the company is opposed to any unfair regulations.

“Our position on further regulations is as it has always been: We would support further regulations as long as they were reasonable and ensured our ability to compete for adult smokers. The legislation as it is would put us at a disadvantage. It is, in essence the same bill from 10 years ago,” he said.

The committee was expected to meet this week to discuss legislation. How or if this legislation could effect the production phase of the tobacco industry remains to be seen, but University of Kentucky extension agent Tommy Yankey said the farmers in his area have other things on their minds.

“There will be some producers with concerns over any FDA regulations, but for the most part, they’ve got other things to worry about, namely the continuing labor issue and growing energy problems,” he said.

History of tobacco regulations

The business of regulating the tobacco industry is not new. More than 300 years ago, England’s King James I labeled tobacco as “loathsome to the eye, hateful to the nose, harmful to the brain” and “dangerous to the lungs,” but the product has remained, although cigarettes did not make a major appearance in this country until after 1870.

In the 1960s the federal government, by way of the Federal Cigarette Labeling and Advertising Act of 1965, instituted the Surgeon General’s warning that smoking could be bad for your health. This warning was required on cigarette packages beginning Jan. 1, 1965, and in cigarette advertising beginning July 1 that year. The warnings were updated with more specific information with the passage of the Comprehensive Smoking Education Act of 1984.

By 1971, ads for cigarettes were banned from television and radio and by the Clinton Administration in the 1990s, an all-out war was declared. On Aug. 28, 1996, then-President Clinton approved the FDA’s involvement with tobacco products and its related Tobacco Rule, which the organization developed to reduce teenage use of tobacco.

In 2000, however, the Supreme Court ruled the FDA could not impose restrictions without congressional involvement. In 2004 the Senate gave that authority to the FDA, but the House let the legislation die.

The economics of tobacco

Regardless of how unhealthy tobacco use may be, its economic impact has played a major role in its existence dating back to the days of colonial Virginia.

Before the buyout legislation three years ago that demolished government-regulated growing quotas and caused many growers to cease production, Kentucky saw revenues topping $900 million at peak production in 1998. That figure has dwindled significantly since then, but the crop still ranks in the top five of all state farm receipts.Besides the revenue farmers receive, the state banks a sizeable amount of money generated by taxes on tobacco. Until 2005, the state had the lowest tax on cigarettes in the country, at three cents a pack, but the General Assembly raised that amount to 30 cents, creating more than $150 million in new revenue. Iowa was the first state to impose a tax on tobacco, in 1921.

The federal government gets its share of revenue from tobacco taxes, at approximately 50 cents per pack. There is legislation being considered by the Senate Finance Committee to increase that tax by 156 percent for the State Children’s Health Insurance Program (SCHIP), generating an additional $35 billion in revenue, according to a statement from Reynolds American.Tommy Payne, executive vice president of public affairs for Reynolds, questioned the government-proposed tax increase as well as the HELP hearings on FDA legislation.

“These consecutive committee actions beg the question of whether the Senate is trying to have it both ways: Sell more cigarettes so the federal government can have billions of dollars more in tax revenue, while at the same time regulating tobacco products to the point no one will use them,” said Payne.

7/26/2007