IOM Recommends FDA Regulation of Tobacco Products

WASHINGTON, May 24 -- The FDA should be given the authority to regulate tobacco as an addictive drug, including marketing, advertising, and, eventually, the right to regulate nicotine content, said an Institute of Medicine report issued today.

"Ultimately, for long-lasting changes in tobacco use, Congress and other policymakers will need to change the legal structure of tobacco policy," said the IOM, which is part of the National Academy of Sciences.

"The first step is to enable and encourage state and local innovation, but that might not be enough. Congress should also confer upon the FDA or another regulatory agency broad regulatory authority over the manufacture, distribution, marketing and use of tobacco products."

"Tobacco manufacturers should be required to disclose all chemical compounds found in both their product and the product's smoke, whether added or occurring naturally, by quantity; to disclose to the public the content and delivery of nicotine based on standards established by the FDA or other regulatory agency; and to disclose to the public research on their product, as well as behavioral aspects of its use."

The IOM said that smoking has declined by more than 50% since the release of the 1964 Surgeon General's report that linked cigarettes to lung cancer and other pulmonary diseases, but about 21% of U.S. adults are still smoking.

"Smoking is a habit with potentially deadly consequences that is often taken up by adolescents before they can truly appreciate the risk of addiction," Richard J. Bonnie, a law professor at the University of Virginia in Charlottesville, who chaired the IOM writing committee. "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."

In the report, Ending the Tobacco Problem: A Blueprint for the Nation, the IOM proposed a number of recommendations aimed at the supply of cigarettes including:

• 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 to 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.

But those measures do not "address the addictive aspects of tobacco or constrain manufacturers' incentives to attract more smokers." As a result, the IOM said it was unlikely that smoking rates would drop below 15% or that smoking by teens would fall below 20%.

The solution, the IOM said, is federal regulation, particularly to give the FDA authority over tobacco. To that end the report also recommended:

• 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.