- The Washington Times - Monday, June 28, 2004

There’s an old saying that “politics makes strange bedfellows.” Just about anybody who knows politics will tell you there is much truth to be found in this phrase.

Perhaps no stranger combination of bedfellows in political discourse has ever come together than one now at work in Washington. To the surprise of many observers, the nation’s largest tobacco company, Philip Morris, has joined forces with a number of anti-tobacco groups to push for regulation of tobacco.

Yes, you read that correctly. The company that makes more cigarettes than any other in America is working closely with organizations such as the Campaign for Tobacco-Free Kids, the American Heart Association, the American Cancer Society and others to advance legislation in Congress that would direct the Food and Drug Administration (FDA) to regulate all tobacco products.

Such a combination of long-time foes should give us pause. And it should make us wonder what is afoot. The anti-tobacco forces seem to want regulation at any cost. And Philip Morris seems to have found a silver lining in regulation. It is instructive to note that Philip Morris is the only tobacco company that supports this legislation. It is also worth noting that Philip Morris dominates the tobacco market in the United States and has roughly half the total market for tobacco products, while the other half is divided by a number of other companies.

The proposed legislation would create numerous restrictions on tobacco advertising, leading many to conclude that one of the goals of Altria Group, Inc., parent company of Philip Morris, is to lock-in and protect its market share. If other companies can’t advertise, then they will have a harder time against the giant of the industry. No doubt, Philip Morris would like that.

Beyond the issue of preserving market share — which is reason enough to question the logic and wisdom of this legislation — the tobacco regulation bill as currently written is flawed in a number of ways.

Key provisions of the bill authorize the FDA to take or refuse action based on whether the decision is “appropriate for the public health.” These provisions include restrictions on tobacco-product sales and marketing, tobacco-product standards, pre-market approval of new tobacco products and claims of reduced exposure to tobacco-product constituents. The standard provides no legislative guidance to the FDA and no judicially enforceable limits on the agency’s discretion. And that spells trouble.

Another section of the legislation imposes the burden on tobacco companies to prove that any tobacco-product standard devised by the FDA will not work. Although the FDA is required to justify a proposed standard in theory, anyone who opposes it must “prove” that it “will not reduce or eliminate the risk of illness or injury.” No other provision of the Food, Drug and Cosmetic Act imposes this kind of evidentiary burden on those subject to FDA regulation. Tobacco should not have to face standards that other substances regulated by the FDA do not.

Under another section of the bill, a tobacco-product standard devised by the FDA, or a refusal on the part of FDA to approve a new tobacco product, is subject to judicial review, but the agency must show only that its action was not “arbitrary or capricious.” This weak judicial-review mechanism, combined with the nebulous “appropriate for protection of the public health” criterion and the burden on tobacco companies to prove that an FDA standard won’t work, undermines administrative due process rights in connection with the most significant actions to be taken by the agency. By comparison, judicial review of FDA standards for medical devices and decisions on approval of new drugs and medical devices require the agency to demonstrate that its actions are based on “substantial evidence.” Again, tobacco is singled out for differing standards of regulation.

In an era when more and more people are coming to see that government regulation — no matter what the industry — is no panacea, we have to look behind the curtain when a company steps up and says to the government, “Please regulate me.”

In this case, such a look reveals that FDA regulation of tobacco is something that we should not rush into. Not now, perhaps never. And certainly not via the very flawed pendinglegislation.Greater thought is called for.

Ken Boehm is chairman of the National Legal and Policy Center.

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