Thursday, March 10, 2005

Philip Morris Test-Marketing Marlboro Ultra Smooth Cigarettes; Health Advocates Call for FDA Regulation

Philip Morris is now test-marketing a new cigarette brand -- Marlboro Ultra Smooth -- which contains a new carbon filter that was presumably designed to help filter out certain toxins in cigarette smoke and to therefore reduce exposure to these toxins. The cigarettes are being test-marketed in Atlanta Tampa, and Salt Lake City. However, Philip Morris is explicitly not making any reduced risk or reduced exposure "health claims." According to a Wall Street Journal article, the company wrote in a Jan. 11 letter to the state attorneys general that it "will not make reduced exposure claims about Marlboro Ultra Smooth because we do not have evidence that the application of these new carbon filters warrants a reduced exposure claim."

Some public health advocates, including Matt Myers, president of the Campaign for Tobacco-Free Kids, are concerned that the marketing of this new brand will mislead the public into thinking that it offers some degree of health protection. In a Richmond Times-Dispatch article, Myers stated: "The critical fact is that the emphasis on 'ultrasmooth,' combined with the reference to a new filter is very likely to result in consumers believing that this is a safer product. Philip Morris doesn't have to make explicit claims to result in consumers being misled."

The Campaign for Tobacco-Free Kids, which last year joined Philip Morris in lobbying Congress for a bill that would give FDA authority to regulate tobacco products, argues that this FDA legislation is necessary to address the fact that smokers are being misled by terms like "light," "ultra-light" and "low-tar" in current cigarettes and could be misled by new "reduced risk" or potentially reduced exposure products (PREPS), like Marlboro Ultra Smooth. The Campaign will direct a session at the 2005 National Tobacco Control Conference in May to address what it states is a "critical need for FDA regulation."

The Rest of the Story

My analysis of the FDA bill considered last year reveals that it would substantially help, not hurt Philip Morris in marketing its Marlboro Ultra Smooth product (and other similar PREPS). Instead of simply having to rely on creative labeling to market the product, under the proposed FDA legislation, Philip Morris could explicitly promote the new brand as a "reduced exposure" cigarette that has been approved by the federal government.

Currently, Philip Morris is apparently reluctant, if not unwilling, to explicitly market Marlboro Ultra Smooth as a reduced exposure product, because it does not feel it has "evidence" to support such a claim and under the Master Settlement Agreement, state attorneys general are scrutinizing the new product and can sue the company if it makes "any material misrepresentation of fact regarding the health consequences of using any tobacco product, including any tobacco additives, filters, paper or other ingredients."

However, if the FDA legislation is enacted (in the form supported by the Campaign for Tobacco-Free Kids last session), Philip Morris could potentially market Marlboro Ultra Smooth as a "reduced exposure" product (explicitly representing to the public that the brand "presents a reduced exposure to a substance in tobacco smoke"). The main burden of proof to the company would be to show that:

(1) "scientific evidence is not available and, using the best available scientific methods, cannot be made available without conducting long-term epidemiological studies for an application to meet the standards set forth [in paragraph (1)]" (see Section 911(g)(2)(A)(iii)); and

(2) "the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is anticipated in subsequent studies" (see Section 911(g)(2)(A)(iv)).

In other words, in the absence of any substantiated evidence of a reduced health risk, Philip Morris could essentially market a product as "reduced exposure" as long as it merely anticipates that a positive effect on health would be expected.

So ironically, the FDA legislation supported by the Campaign for Tobacco Free Kids and Philip Morris might actually put Philip Morris in the position of being able to make explicit reduced exposure claims that it cannot (or at least is unwilling to make) right now. This is most likely one of the major reasons why Philip Morris wants the FDA bill so badly.

By setting up a regulatory "permit" process for cigarettes for which a reduced exposure claim is made, the FDA legislation would explicitly force the federal government to permit such claims. This is the classic fallacy that underlies the actions of many public health groups that believe federal regulation is the answer to the problem of controlling corporate behavior.

Perhaps more importantly, as the Campaign for Tobacco-Free Kids readily admits (see quote above), Philip Morris doesn't have to actually make health claims to result in consumers being misled. If this is true, then requiring FDA approval only of those tobacco products whose marketing represents that they improve health or reduce exposure is not going to solve the problem.

The rest of the story reveals that although PREPS like Marlboro Ultra Smooth are problematic, the FDA legislation supported by Philip Morris and Tobacco-Free Kids will make the problem worse, not better: it will specifically permit reduced exposure claims to be made in the absence of substantiated evidence of reduced health risk -- exacerbating the very problem that the legislation is purported to solve.

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