The House of Representatives is poised to vote next week on a pioneering bill that would give the Food and Drug Administration its first real power to regulate tobacco products, much as it now regulates food, drugs and medical devices. This is a critically important bill, the culmination of more than a decade of struggle to bring the renegade tobacco industry under regulatory control.
In the 1990s, the F.D.A. tried to regulate tobacco products under existing statutes, but the Supreme Court ruled that the agency had exceeded the authority granted by Congress. Now both houses are considering bills that would write the agency’s 1996 rules into law and add many other tools and powers as well. David Kessler, the former food and drug commissioner who led the regulatory battle more than a decade ago, called it “as strong a tobacco bill as we have seen in our lifetimes.”
The bill pending in the House would empower the F.D.A. to regulate both the content and marketing of tobacco products. The agency could not ban tobacco products outright or eliminate all nicotine from them, but it could reduce the levels of nicotine, eliminate other harmful ingredients and set product standards to protect the public’s health. It could also restrict advertising and promotion to the extent permitted by the First Amendment.
The Bush administration has opposed the bill on several grounds — none of them compelling. Its core objection is that the bill would heap new responsibilities on the F.D.A. at a time when the agency is struggling to enhance food safety and improve oversight of imported drugs, devices and foods. Of course, the reason the agency is struggling is that the administration, true to its animus against regulation, has failed to provide adequate resources during most of its tenure. The solution is to provide enough money and people to perform all vital tasks, not to duck a new one.
The administration further frets that user fees imposed on the tobacco industry won’t cover all costs of the regulatory effort, thus forcing the F.D.A. to cannibalize other programs to make up the difference. But the bill now clarifies that only the designated user fees and no other F.D.A. funds can be used to regulate tobacco.
The administration also contends — as do some anti-tobacco activists — that F.D.A. oversight could leave the public with the misperception that tobacco products are safe, or at least safer, with regulation. But the bill prohibits tobacco companies from implying that they have F.D.A. approval, and the agency has ample ways to remind the public that tobacco is harmful.
The bill has strong support from such organizations as The American Cancer Society, the American Heart Association, the American Lung Association and the Campaign for Tobacco-Free Kids. It is supported by Philip Morris, but opposed by most of the tobacco industry. It has strong bipartisan support in Congress.
The legislation needs to be passed this year by veto-proof margins in both houses, lest the reform impulse dissipate next year as a new administration and new Congress grapple with a host of complicated foreign, military and domestic issues.
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