Congress again tries to give FDA control over tobacco

Many would welcome regulation, but some question whether FDA oversight will lead to the erroneous conclusion that tobacco products will be safer.

By Susan J. Landers — Posted March 19, 2007

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Some members of Congress have launched a repeat effort to give the Food and Drug Administration regulatory authority over tobacco products. Supporters of bipartisan House and Senate bills, including the AMA, hope that this time will prove the charm.

Although the bills would not allow the FDA to ban tobacco, they would allow the agency to restrict the advertising and promotion of tobacco products to children, identify toxic substances, require the placement of new and larger warning labels, and fast-track the development and approval of new nicotine replacement products. Tobacco companies also would be charged user fees to cover the FDA's regulatory costs.

Tobacco use remains the single most preventable cause of death in the United States, according to the American Heart Assn., which also backs the measures. More than 440,000 people in the U.S. die each year from tobacco-related diseases, with heart disease, stroke and other cardiovascular diseases accounting for more than one-third of deaths, according to the AHA.

"Each day, approximately 4,000 kids will try a cigarette for the first time, and another 1,000 will become new, regular, daily smokers," said AMA President-elect Ron Davis, MD, in a statement. The AMA applauded the new bills for their potential, especially to protect children.

"Given what we know about the health effects of smoking and the powerful addictive properties of nicotine, it is unconscionable that tobacco products are currently one of the least regulated products in our society," said Dr. Davis, who directed the Center for Disease Control and Prevention's Office on Smoking and Health from 1987 to 1991.

Tobacco regulation has been attempted before, most recently in 2004 when the Senate approved the same bill that is now back in play in the new Congress. With Democrats in control of both chambers, supporters believe the chances of passage may have improved.

In 1996 the FDA took steps to regulate tobacco products, citing the authority of the Food, Drug and Cosmetic Act. But tobacco companies sued, and the U.S. Supreme Court ruled in 2000 that Congress had not given the FDA legal authority to exercise control over these products.

The Family Smoking Prevention and Tobacco Control Act, introduced in the Senate by Sens. Edward Kennedy (D, Mass.) and John Cornyn (R, Texas) and in the House by Reps. Henry Waxman (D, Calif.) and Tom Davis (R, Va.), could provide that authority.

Dissenting voices

But Sen. Michael Enzi (R, Wyo.), the ranking Republican on the Health, Education, Labor and Pensions Committee, expressed his opposition at a Feb. 27 hearing, saying the bill could promote the distressing message that FDA regulation would result in a safer cigarette. Not so, he noted. "Forcing the FDA to regulate tobacco but not letting them ban it would undermine the long history of the agency protecting and promoting the public health."

Alan Blum, MD, director of the University of Alabama Center for the Study of Tobacco and Society, agreed. "Asking [the FDA] to promulgate 'product safety standards' for this death-dealing device is an oxymoron and will perpetuate the myth that cigarettes can be made safer. Safer than what, one might ask: fresh air?"

The Bush administration has opposed such legislation in the past.

But the bills have garnered the support of many House and Senate co-sponsors as well as numerous health organizations. Matthew Myers, president of the Campaign for Tobacco-Free Kids, a Washington, D.C.-based anti-smoking advocacy group, said the bills have the potential to save millions of lives.

Tobacco is the one consumer product that no federal agency oversees for health and safety purposes, Myers told the Senate panel. "This carefully crafted, thoughtfully balanced legislation would correct that glaring problem and bring the type of government oversight to the manufacture, marketing and sale of tobacco products that already is provided to other consumer products."

The bills also have broad voter support, Myers said, even among smokers. Tobacco manufacturer Philip Morris, USA, supports the measures, citing their ability to bring predictability and clear standards to the tobacco industry.

Supporting testimony also was given by Elmer Huerta, MD, MPH, incoming president of the American Cancer Society. "As a physician and researcher who specializes in cancer prevention and screening among the medically underserved, I see firsthand the toll tobacco takes on our country and the benefits of prevention in combating cancer."

The tobacco companies have been able to sidestep the limited advertising restrictions placed on them by the 1998 Master Settlement Agreement reached between the companies and many state attorneys general, Dr. Huerta said.

The companies continue to target children in their ads, he charged. And their most recent efforts to entice young people to smoke have included the introduction of candy-flavored cigarettes, he added.

The states aren't strong enough to fight this industry, said Gregory N. Connolly, DMD, MPH, director of the Tobacco Control Research Program at Harvard University in Cambridge, Mass.

Dr. Connolly directed the Massachusetts Dept. of Public Health's Tobacco Control Program for several years. Although the program acted to curb smoking in the state, it lacked resources and the legal authority to fill the federal regulatory void, he said.

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Putting heat on tobacco

Provisions of Senate and House bills introduced Feb. 15 would allow the Food and Drug Administration to:

  • Regulate the sale and distribution of tobacco products.
  • Restrict advertising of tobacco products, particularly to children.
  • Require new and larger warning labels on cigarette packages and advertisements and on smokeless tobacco products.
  • Regulate the levels of tar and nicotine and ban the addition of candy or fruit flavors to cigarettes.
  • Require tobacco companies to disclose research on the health and dependency effects or safety of their products.
  • Charge manufacturers and importers user fees to cover the cost of regulatory activities.

Source: The Family Smoking Prevention and Tobacco Control Act, S 625 and HR 1108

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External links

"The Need for FDA Regulation of Tobacco Products," Senate Health, Education, Labor and Pensions Committee hearing, Feb. 27 (link)

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