FDA should be given broad regulatory authority over tobacco marketing, packaging, and distribution

May 28 2007

A combination of increased excise taxes, nationwide indoor smoking bans, and other measures would significantly lower the U.S. smoking rate, which now hovers at around 21 percent of the adult population, says a new report from the Institute of Medicine.

But to achieve faster, more certain reductions, the U.S. Food and Drug Administration (FDA) should be given broad regulatory authority over tobacco marketing, packaging, and distribution, and other revisions to current tobacco policy should be enacted, said the committee that wrote the report.

Although smoking in the United States has declined by more than 50 percent since 1964, tobacco use still claims about 440,000 lives every year, and secondhand smoke causes another 50,000 deaths annually. Smoking-related health costs are estimated to be $89 billion a year.

The report proposes a two-pronged approach to further reduce tobacco use in the United States. The first element focuses on strengthening existing tobacco control measures to preserve and enhance the gains already made. The committee's recommendations include:

• Increasing the federal excise tax on cigarettes substantially, and boosting taxes in states with lower rates to achieve greater parity in prices nationwide and thwart interstate smuggling.
• Dedicating $15 to $20 per capita annually of the proceeds from higher taxes or other resources to fund tobacco control efforts in each state.
• Imposing smoking bans in all nonresidential indoor settings nationwide, including restaurants, bars, malls, prisons, and health care facilities.
• Requiring all public and private health insurance plans to make coverage of smoking cessation programs a lifetime benefit.
• Licensing retail outlets that sell tobacco products.
• Launching additional efforts aimed at curbing youth interest in smoking and access to tobacco, including bans on online sales of tobacco products and direct-to-consumer shipments.

These measures focus on reducing demand for cigarettes, but do not address the addictive aspects of tobacco or constrain manufacturers' incentives to attract more smokers. The committee expressed concern that overall smoking rates may not drop significantly below 15 percent and that youth smoking rates may not fall permanently below 20 percent unless the basic legal framework of the tobacco market is changed. Therefore, it proposed a second set of further-reaching recommendations. Specifically, the committee called for:

• Changing federal law to give FDA authority to regulate tobacco products, including powers to restrict how they can be marketed.
• Removing federal restrictions on state laws so that states are free to supplement federal regulations with more stringent measures to suppress smoking.
• Limiting tobacco advertising and promotional displays to text-only, black-and-white formats.
• Prohibiting tobacco companies from using misleading terms such as "mild" and "light."
• Requiring new, large pictorial warnings on the harmful effects of smoking -- similar to those required in Canada -- on all cigarette packs and cartons.
• Requiring manufacturers to correct false or misleading information on products and at the point of sale.
• Restricting the type or number of outlets that can sell tobacco products, and requiring them to display warnings and give a proportional amount of space to cessation aids.
• Prohibiting tobacco companies from targeting youth for any purpose and urging them to redirect money they now spend on prevention to independent public health organizations.
• Developing a plan for gradually reducing the allowable nicotine content of cigarettes.

Cigarettes are a unique consumer product in that they contain carcinogens and other dangerous toxins and would be banned under federal public health statutes if these statutes did not expressly exempt tobacco, the report states. Tobacco is the only legal product for which the government's stated goal is to suppress use altogether rather than to promote safe or responsible use. Moreover, recent revelations of the industry's efforts to manipulate nicotine levels to encourage addiction have eroded the supposition that all smokers have freely assumed the risks of smoking and are solely responsible for the consequences, the committee noted.

"Smoking is a habit with potentially deadly consequences that is often taken up by adolescents before they can truly appreciate the risk of addiction," said committee chair Richard J. Bonnie, John S. Battle Professor of Law and director, Institute of Law, Psychiatry, and Public Policy, University of Virginia, Charlottesville. "We propose aggressive steps to end the tobacco problem -- that is, to reduce tobacco use so substantially that it is no longer a significant public health problem. This report offers a blueprint for putting the nation on a course for achieving that goal over the next two decades."

The desire to educate youth and limit their access to tobacco underlies many of the committee's recommendations because of the high rate at which teens start smoking. Most smokers start before they turn 18, and the rate of daily smoking among high school seniors has hovered around 20 percent for most of the past two decades. Adolescents generally recognize the harmful effects of smoking, but typically overestimate their ability to escape addiction and fail to appreciate fully the personal impact of the long-term health consequences, the report says.

The committee believes that federal regulation is an essential element of a comprehensive approach to tobacco control. Therefore, it urges Congress and the president to give FDA the authority to enforce standards for nicotine reduction and to regulate companies' claims that their products reduce exposure or risk. And the agency should have the authority to restrict the kind or number of outlets that can sell tobacco products and limit how the industry promotes its products.

The committee acknowledged that its recommendations to impose greater restrictions on tobacco advertising may not survive a challenge on First Amendment grounds. However, the report argues that restricting companies' ability to encourage smoking while still enabling them to relay information about the characteristics of their products to consumers satisfies the constitutional rights of the industry and consumers.

As a long-term strategy, the report also recommends that FDA look into developing a plan to gradually reduce the nicotine content of cigarettes and thereby decrease their addictive power. The committee noted that this proposal requires further investigation and careful assessment before it is implemented, but said it offers a reasonable prospect of making it easier for smokers to quit and to decrease the likelihood that youthful or casual smokers would progress to regular smoking.