Tobacco regulation closer with House bill's passage

The measure would reinstate a 1996 FDA rule that was struck down by the U.S. Supreme Court.

By Susan J. Landers — Posted April 27, 2009

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Public health groups are cheering House passage of a bill that would grant the Food and Drug Administration the authority and the resources to regulate the manufacture, marketing and sale of tobacco products.

The House passed the Family Smoking Prevention and Tobacco Control Act on April 2 by a 298-112 vote. The measure's chances are thought to be good for Senate passage, and President Obama has said he will sign it. The 2008 version also passed the House, but the Senate never took it up, and the Bush administration threatened a veto.

This year, Senate opposition is being advanced by Sen. Richard M. Burr (R, N.C.), who introduced a competing measure that would create a federal program to regulate tobacco, rather than provide that authority to the FDA.

Health care organizations, including the American Medical Association, have long fought for tobacco's regulation, noting it is the No. 1 cause of preventable death in the nation, killing more than 400,000 Americans and costing the nation $96 billion in health care bills each year.

The House-passed bill is backed by more than 1,000 public health, faith, medical and other organizations, said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids. The campaign is a Washington-based advocacy group that has worked for years on this issue.

Calling the bill's passage "a step toward better regulation of tobacco," AMA President Nancy H. Nielsen, MD, PhD, noted that the legislation "is critical to combat smoking-related diseases and help get cigarettes out of the hands of children."

Other health advocates echoed this position.

"If enacted, the legislation will contribute to a reduction in the number of children and teenagers who smoke, by limiting their access and exposure to tobacco products," noted American Osteopathic Assn. President Carlo J. DiMarco, DO. "Ultimately this will lead to a healthier population, a decrease in smoking-related illnesses and diseases and lower health costs."

However, as was the case in earlier bills, the measure would not allow the FDA to ban tobacco products outright or to eliminate nicotine.

Reviving a 1996 rule

The bill would reinstate a 1996 rule under which the FDA claimed authority to regulate cigarettes and smokeless tobacco products. That rule was struck down in 2000 by the U.S. Supreme Court in FDA v. Brown & Williamson Tobacco Corp. The court ruled that the FDA did not have the power to enact and enforce the regulation.

Since then, many anti-smoking advocates have fought to provide the FDA that authority by law.

Some have questioned the ability of the agency, which has been criticized for inaction in the wake of several large drug recalls and outbreaks of food-borne illnesses, to take on yet another duty. But others have stepped forward in support of the agency. Among them is David Kessler, MD, who pushed the 1996 rule while serving as FDA commissioner from 1990 to 1997.

In a letter of support for the House measure, Dr. Kessler was joined by former Secretary of Health and Human Services Donna Shalala, PhD, and former Surgeon General David Satcher, MD, PhD. "Having thoroughly studied this issue, we believe that the bill gives the FDA the resources it needs to do the job properly; and, without question, the FDA is the right agency to implement this new regulation because it has a public health mandate and the necessary scientific and regulatory experience," they wrote.

Among its provisions, the bill would restrict tobacco marketing and sales to young people with a series of actions that are to take effect within one year of its enactment. It would ban all outdoor tobacco advertising within 1,000 feet of schools and playgrounds and all remaining tobacco-brand sponsorships of sports and entertainment events.

The measure would place restrictions on tobacco ads in publications with teen readership, and on vending machine sales and self-service displays of tobacco products. Retailers also would be required to verify age for all over-the-counter sales.

In addition, the bill would ban candy-flavored cigarettes and require the study of menthol-containing products. Manufacturers also must disclose to the FDA the ingredients in each tobacco product.

The legislation garnered the support of the Altria Group Inc., which owns tobacco giant Philip Morris USA, the U.S. Smokeless Tobacco Co. and John Middleton Co., a cigar manufacturer. The group said it believes that "on balance" the legislation "provides an important step forward toward providing tough but reasonable federal regulation of tobacco products."

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Bill highlights

The Family Smoking Prevention and Tobacco Control Act would grant the Food and Drug Administration the authority to regulate the advertising, marketing and manufacturing of tobacco products. The bill also would:

  • Grant the FDA specific authority to restrict tobacco marketing.
  • Require companies to disclose ingredients in each tobacco product.
  • Give the FDA authority to require changes in current and future tobacco products to protect public health. The agency could reduce or limit harmful ingredients and additives, including menthol and nicotine, but it would not be allowed to eliminate nicotine or ban classes of tobacco products.
  • Prohibit the use of such descriptors as "light," "mild," and "low" on labels or in advertising.
  • Require larger and more specific health warnings on products that cover the top 30% of the front and rear panels.
  • Reinstate the FDA's 1996 rule restricting tobacco marketing and sales to young people.

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