Monday, March 17, 2008

FDA Legislation Supporters Admit that Bill is Severely Flawed and Would Harm Health by Undermining Health Messages; Resort to Unconstitutional Ploy

The supporters of FDA tobacco legislation have finally admitted that what I and a number of other tobacco control advocates have been saying about the proposed legislation currently before Congress is true: the bill is severely flawed because it would harm the public's health by undermining public health messages about the dangers of cigarettes, thus leading to increased smoking and adverse health consequences.

In my statement submitted to the Senate Health, Education, Labor, & Pensions Committee, I testified that: "By giving tobacco products an FDA stamp of approval, the legislation will undermine the public’s appreciation of the dangers of cigarettes, but without actually ensuring that these products are significantly safer. ... It will reduce the public's perception of the inherent harms of cigarettes. By promulgating health standards, FDA will be giving the public the perception that cigarettes are now safer to smoke. The public is not necessarily aware of the 4,000 toxins and 50+ carcinogens in the smoke, nor are they epidemiologists - if they are told that the nitrosamines have been removed, they are naturally going to perceive that the problem is being taken care of, or at least largely taken care of. Since we know that smoking prevalence is directly proportional to the degree of perceived harm from smoking, this will lead to an increase in smoking prevalence (at least compared to what would have occurred in the absence of the legislation)."

Apparently in acknowledgment of this point, the supporters of the FDA legislation have added a new provision to the legislation, prefaced by the following statement of principle: "If manufacturers are permitted to state or imply in communications directed to consumers that a tobacco product is approved or inspected by the Food and Drug Administration or complies with Food and Drug Administration standards, consumers are likely to be confused and misled. Such a statement could result in consumers being misled into believing that the product is endorsed by the Food and Drug Administration for use or in consumers being misled about the harmfulness of the product because of such regulation, inspection, approval or compliance."

Because of this problem, the FDA legislation would essentially result in the transfer of fraud that in the past was committed by tobacco companies over to the federal government. Previously, it was the tobacco companies that were falsely implying that their products were somehow safer because of product design changes such as reduced tar and nicotine levels (the companies were found guilty of racketeering largely because of this). Now, under the FDA legislation, the bill's supporters readily admit that it will be the federal government which is misleading consumers into believing that the product is safer, when in fact there is no documentation that it is. In other words, it is now the government that will be committing fraud, instead of the tobacco companies.

Not only do FDA legislation supporters now readily admit that this is what the bill does; they feel so strongly about the unacceptability of these perverse consequences that they have amended the bill so as to legally prevent the companies from publicly stating that the FDA has approved cigarettes, or even that the FDA regulates cigarettes or that a tobacco company is complying with the FDA regulations regarding their products.

The added provision to the legislation precludes the tobacco companies from making: "any statement directed to consumers through the media or through label, labeling, or advertising that would reasonably be expected to result in consumers believing that the product is regulated, inspected, or approved by the Food and Drug Administration, or that the product complies with the requirements of the Food and Drug Administration, including a statement or implication in the label, labeling, or advertising of such a product, that could result in consumers believing that the product is endorsed for use by the Food and Drug Administration or in consumers being misled about the harmfulness of the product because of such regulation, inspection, approval, or compliance."

The Rest of the Story

It's heartening to know that both supporters and opponents of the FDA tobacco legislation within the tobacco control community are now on the same page as far as its harmful effects on the public's health, due to the implied safety of cigarettes that consumers will perceive due to this regulatory scheme and as far as the unacceptable and perverse effect that the legislation will have in terms of the transferring of fraud from the tobacco companies to the federal government.

What remains boggling, however, is why the supporters of this legislation would continue to support it, given that they acknowledge these perverse and detrimental effects.

If the supporters believe that by precluding the tobacco companies from communicating to the public that cigarettes are regulated by FDA, they will be able to prevent the public from finding out about the legislation, they are deceiving themselves. Communications from tobacco companies are not the only way that the public obtains information. There are also newspapers, television stations, radio stations, and the internet. Surely the public is going to become aware that cigarettes are under the regulatory jurisdiction of the FDA, even if the cigarette companies are prohibited from telling the public.

Thus, the fix that bill supporters have proposed is an ineffective one. If they are truly concerned that the public is going to be misled about the safety of cigarettes by finding out that the product is "regulated" by the FDA or that cigarette companies are complying with FDA regulations on tobacco products, as the legislation states, then there is simply no way to prevent that from happening. You just can't stop the public from finding out that this bill passes, if it does. The media are going to cover this issue heavily and the public is going to find out that cigarettes have been placed under the regulatory jurisdiction of the FDA.

The fact that bill supporters felt the need to insert a clause stating that tobacco companies cannot tell the truth about their products - and must hide the fact that the FDA regulates cigarettes and that these companies comply with those regulations - demonstrates how weak this legislation really is.

If you need to hide from the public the fact that the FDA regulates cigarettes because it is going to undermine their appreciation of the hazards of cigarettes, then perhaps FDA regulation of cigarettes is not such a good idea in the first place. And if you have to force cigarette companies to hide the truth from their consumers in order to avoid perverse consequences from your regulatory scheme, then perhaps you need to go back to the drawing board.

To make matters worse, the fix provision that bill supporters have inserted is clearly unconstitutional, as it violates the free speech rights of the tobacco companies.

How can you infringe upon the free speech right of tobacco companies to simply tell their consumers the truth about the regulatory status of their products?

It would be one thing if the legislation precluded the companies from misleadingly implying that because of FDA regulation of cigarettes, the product is now safer. However, that's not what the legislation does. It imposes an outright ban on cigarette companies merely stating the simple truth that the FDA has regulatory authority over cigarettes. It bans the simple, materially truthful statement that a tobacco company is in compliance with FDA regulations.

Can you imagine a similar ban on any other company? Suppose that Congress passed a bill that did not allow the manufacturers of pharmaceuticals from informing the public that their products are regulated by the FDA. That would clearly be viewed as an infringement of the pharmaceutical companies free speech rights. The same is true of the tobacco companies and their right to make materially truthful statements to the public.

This is especially true of statements for which there is no dispute about their deceptiveness. No one would or could dispute that the statement: "Tobacco products are now under the regulatory authority of the FDA" would be a truthful and non-deceptive statement should the legislation be enacted. Yet the legislation would prevent the tobacco companies from making such a statement.

In fact, the legislation would prevent a tobacco company from even stating: "Tobacco products are now under the limited regulatory authority of the FDA," or "Tobacco products are now under an extremely limited regulatory scheme by the FDA."

Furthermore, a tobacco company could not even report to consumers that the FDA legislation was enacted, since that would reasonably be expected to result in those consumers believing that the FDA regulates cigarettes. So if Philip Morris wants to report, on its website, that the FDA legislation was enacted, that would be precluded by this legislation.

This legislative provision clearly fails the 4th prong of the Central Hudson criteria for the regulation of commercial free speech because it is far more broad than is reasonably necessary to achieve the stated government purpose in regulating the speech. Here, the purpose is to prevent the deception of consumers, yet the legislation prevents telling the material, indisputable truth.

If you need to rely on an unconstitutional alteration to your legislation to prevent it from having detrimental effects on the public's health, I would suggest that a better approach would be to re-work your legislation so that it doesn't have such detrimental effects. Unfortunately, the health groups supporting the FDA legislation are committed to passing the bill in its present form, regardless of their own admission that it is going to mislead consumers - falsely - into believing that cigarettes are safer, and even though it is going to transfer the fraud previously committed by tobacco companies (for which we have attacked and convicted them) over to the federal government.

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