Thursday, March 19, 2009

Major Section of FDA Tobacco Legislation is Blatantly Unconstitutional and Will Be Struck Down; Bill Will Give FDA Seal of Approval to Cigarettes

Today I reveal that a major section of the proposed FDA tobacco legislation currently being considered by the U.S. House of Representatives is blatantly unconstitutional as it interferes with the First Amendment free speech rights of tobacco companies and will almost certainly be struck down by the courts.

Background

One of the major criticisms I have leveled against the proposed legislation is that it would give cigarettes an FDA seal of approval, thus undermining the public's appreciation of the hazards of smoking and providing the tobacco companies with a golden marketing opportunity. The companies could start boasting that their products are officially approved by the U.S. Food and Drug Administration and that they comply with all federal regulations and requirements regarding the safety of tobacco products.

Can you imagine statements on cigarette packages, advertisements, and web sites which state: "Our products are strictly regulated by the United States Food and Drug Administration. The FDA has approved this product for sale in the U.S. It meets all regulatory safety standards promulgated by the FDA."

To be sure, this would be a public relations bonanza for the industry. I would love to be on the public relations staff of a cigarette company after the law is enacted. Can you imagine the fun the public relations departments of the tobacco companies will have?

Well, apparently in response to my criticism on this point, supporters of the FDA tobacco legislation revised the bill to attempt to prevent the cigarette companies from gaining a public relations benefit from the approval of cigarettes by the FDA.

First, they added the following statement of purpose to the legislation [section 2(46)]:

"If manufacturers state or imply in communications directed to consumers through the media or through a label, labeling, or advertising, 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. Depending upon the particular language used and its context, 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."

Thus, supporters of the bill have explicitly stated that they agree with my concern about the legislation. They acknowledge that the legislation will give cigarettes an FDA seal of approval and provide Big Tobacco with a golden public relations opportunity that will likely result in misleading the American public into believing that cigarettes are less harmful. The bill's supporters assert that communicating to the public that cigarettes are regulated, inspected, and/or approved by the FDA, or that cigarette companies are in compliance with FDA safety standards, will mislead the public and undermine the public's appreciation of the hazards of smoking.

In order to address this glaring problem, the bill's supporters inserted the following section into the legislation [section 103(tt)]:

[Cigarette companies may not make] "any statement directed to consumers through the media or through the 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 product, and 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, or compliance."

By precluding the companies from making statements which assert or imply that cigarettes are regulated or approved by the FDA or that their company is in compliance with FDA regulations, the bill supporters hope to avoid the above problem.

The Rest of the Story


There's just one problem with this approach to the problem: it's unconstitutional.

Prohibiting cigarette companies from making statements which are demonstrably true, and which are undeniable, material facts, is clearly a violation of the First Amendment to the Constitution. The FDA legislation violates the cigarette companies' free speech rights by preventing them from making truthful, verifiable, and non-misleading statements of material fact. Furthermore, no government interest is directly advanced by this prohibition of truthful communication and the restriction is more intrusive than necessary to advance the government's interest in preventing the public from falsely believing that cigarettes are safer.

If the FDA legislation is enacted, it will be undeniably true and verifiable that cigarettes are regulated by the federal government. What government interest is directly advanced by prohibiting companies from making true statements about the regulation of the product and how is such a prohibition the most narrowly tailored approach to advance such an interest?

In 1995, the U.S. Supreme Court addressed a similar issue. Can the federal government prohibit alcohol companies from stating in their labeling the alcohol content of their products?

Because of concern that allowing alcohol companies to disclose the alcohol content of their products might lead to "strength wars" between various companies and to marketing based on the potency of various beer brands, Congress enacted section 5(e)(2) of the Federal Alcohol Administration Act which prohibited beer labels from displaying the alcohol content.

In the case, the U.S. Supreme Court held that the alcohol companies were disclosing "only truthful, verifiable, and nonmisleading factual information concerning alcohol content," and that precluding the communication of this truthful and non-misleading information neither directly advances a government interest nor is tailored narrowly enough to be the least intrusive measure available to advance that interest (see: Rubin v. Coors Brewing Co., 514 U.S. 476 [1995]).

In the case of the FDA legislation, the FDA has the authority to regulate the safety of cigarettes. Thus, a more narrowly tailored alternative to prevent the public from falsely believing that cigarettes are less harmful is to regulate cigarettes so that they are less harmful. And if the FDA cannot regulate cigarettes so that they are less harmful, then what exactly is the point of the legislation in the first place?

Ironically, in order to defend the law, the U.S. government would have to assert that it cannot make cigarettes safer by regulating the product. Otherwise, such regulation would constitute a less intrusive approach to ensure that the public does not falsely believe that cigarettes are safer. But if the government acknowledges that it cannot actually make cigarettes safer, then it has destroyed the very rationale behind the legislation in the first place.

I don't think there is any doubt that section 103(tt) will be struck down by the courts. That will leave the cigarette companies free to communicate to the public (correctly and truthfully) that their products are regulated by the FDA and that the companies are in compliance with the FDA's safety requirements for these products.

It will be a public relations field day.

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