Wednesday, October 26, 2005


This is the second of a two-part series in which I discuss why I think the proposed FDA tobacco legislation would be a disaster for public health.

In the first part of the series, I discussed how the proposed legislation would provide the tobacco companies with immunity from litigation related to false and misleading health claims regarding potentially reduced risk exposure products (PREPS), thereby opening the market to the introduction of these products and to the government-sanctioned dissemination of unproven health claims to the public.

In contrast to the Campaign for Tobacco-Free Kids, which has claimed that the proposed bills would "protect kids and save lives," my analysis of the legislation concludes that this legislation would actually endanger kids and result in increased mortality. In this second part of the series, I discuss this aspect of my analysis.

Ultimately, I argue, the proposed FDA legislation would result in a government stamp of approval for tobacco products, including potentially reduced exposure products for which there is no substantial evidence of decreased health risk, resulting in an undermining of the public's appreciation of the health hazards of smoking and therefore, to increased smoking initiation and reduced smoking cessation.

The Rest of the Story

A recent research report by J.P. Morgan on PREPS (The Third Innovation: Potentially Reduced Exposure Cigarettes, August 25, 2005) provides an insightful analysis of the potential impact of the proposed FDA tobacco legislation on the public's perceived risk of smoking and on its smoking behavior.

The J.P. Morgan analysis concludes that: "90% of smokers are willing to try a safer cigarette. Overwhelming smoker demand for a reduced risk alternative to conventional cigarettes suggests to us that, over a 30-year period, the PREPS category could become as big as the 'lights' cigarette segment."

The report concludes, based on a survey of smokers, that:
  • 87% of smokers are looking to quit smoking for health reasons;
  • 91% of smokers would be willing to try a lower risk cigarette if it were available;
  • 85% of smokers would be willing to switch brands if necessary to smoke a lower health risk cigarette;
  • 89% of smokers would be more willing to smoke a reduced risk cigarette if it was their current brand; and
  • young smokers may be "particularly receptive" to PREPS.
Clearly, the implication of these research findings is that there is a huge potential market for PREPS because a huge proportion of smokers are concerned about the health effects of smoking and would welcome the opportunity to continue smoking yet face reduced health risks. Inevitably, this means that the introduction of PREPS, just like the introduction of "light" cigarettes, would provide an alternative to quitting smoking and therefore result in smokers switching to PREPS who might otherwise quit smoking.

In addition, the report makes it clear that the FDA legislation would result in a government stamp of approval of tobacco products, including PREPS: "FDA oversight would imbue PREPS with a regulatory 'stamp of approval' and allow for more explicit comparative health claims with conventional cigarettes."

I believe that this perception of a government stamp of approval of tobacco products would contribute to the public perceiving a lower risk of cigarette smoking.

After all, the public seems more likely to get their perception of the risks of smoking from the government (including its public health agencies) than from the tobacco companies. The J.P. Morgan smoker survey revealed that the majority (61%) of smokers do not believe that the tobacco companies tell the truth about the risk of smoking. It concludes that: "Consumers should trust the FDA more than industry health claims."

If there is a high level of consumer trust in the FDA and the FDA regulates tobacco products, then naturally, there is going to be an increased public perception that cigarettes are now safer, regardless of any actions that the FDA may or may not take to regulate the constituents of tobacco smoke and the true impact of that regulation on human health.

In other words, to a certain extent the status quo -- specifically, the absence of FDA regulation of tobacco products -- actually limits the degree to which tobacco companies are able to convince consumers that cigarettes are not as dangerous as currently believed because companies can make no claim that the product is stringently regulated.

But imagine what would happen if the companies could claim, quite accurately, that the federal government has now assumed stringent regulatory authority over the design, ingredients, additives, and constituents of tobacco products. Naturally, there would be a public perception that the product is not as hazardous as currently thought, because it is now under the strict regulation of the federal government (and in fact, under the jurisdiction of the same agency that makes sure that pharmaceuticals and medical devices are safe).

Unquestionably, the erosion of the public's perceived level of the health risk associated with cigarette smoking would lead to an increased level of youth smoking initiation and a reduced level of adult smoking cessation.

In other words, the FDA legislation, if enacted, would endanger kids and likely result in increased mortality by reducing the perceived level of harm of cigarettes, increasing cigarette smoking among both youths and adults because of the reduced level of perceived harm, and increasing the level of cigarette smoking among adults, especially young adults, by convincing smokers who might otherwise quit to instead switch to a cigarette brand whose marketing, approved by the federal government, implies that the product will be safer.

J.P. Morgan estimates that by 2009, sales of PREPS will amount to well over 10 billion cigarettes. There is simply no way that a change in the market of this magnitude will not affect the public's perceived level of risk of cigarettes as a product and the proportion of smokers who quit smoking as opposed to switching to what they perceive as less hazardous cigarette brands.

One might ask the question: what if PREPS really do reduce the risk of disease? Will that not be a major benefit for public health?

The problem is that the best current evidence is that there is no reason to believe that PREPS do or will reduce the risk of disease. A recent review by researchers at the University of Minnesota concluded that: "To date, there is no evidence to suggest that there is enough of a reduction in tobacco toxin exposure with any of the existing PREPs to expect a significant reduction in disease risk, nor do we know the extent of toxin exposure reduction that is necessary to result in reduction of disease."

The Campaign for Tobacco-Free Kids, the main supporter of the FDA legislation outside of Philip Morris, itself stated that "there is no evidence to conclude that any of these new tobacco products actually reduce the risk of disease to consumers."

If the problem is the potential for misleading or unsubstantiated health claims for PREPS, then the status quo (in which tobacco companies cannot market the products for fear of being sued for making these unsubstantiated claims) seems far better a situation then the FDA legislation (under which tobacco companies can make the same unsubstantiated claims becuase there is no longer any fear of litigation).

This problem is compounded even further by the failure of the proposed FDA legislation to provide adequate measures to ensure that FDA-approved reduced exposure products will not make unsubstantiated health claims.

The legislation contains a loophole, highly sought after by Philip Morris and agreed to by the Campaign for Tobacco-Free Kids, which allows products to be marketed to the American people even if there is not adequate evidence that they will be safer. The only hitch is that the cigarette companies can only claim that the product is a "reduced exposure" product, rather than a "reduced risk" product.

But what does it matter? To the average consumer (and even to the way-above-average consumer), the claim of reduced exposure is naturally going to imply that the product is safer, even if the cigarette companies do not directly make such a claim.

Why in the world did the Campaign for Tobacco-Free Kids agree to this highly-sought-after loophole by Philip Morris?

I can't answer that question. All I can do is reiterate what I said before: With "enemies" like the Campaign for Tobacco-Free Kids, Philip Morris does not really need friends - the Campaign is doing its bidding for it in the halls of Congress.

And the result of that bidding, if successful, would be the erosion of the perceived public perception of the harms of cigarette smoking, largely due to a perceived government stamp of approval of tobacco products and to the tobacco company's newly-found ability to publicly disseminate the fact that tobacco products are now stringently regulated by the federal government.

You can't erode the public's perception of the harms of cigarettes without also eroding the public's health. And ultimately, that is what I think the FDA legislation will do.

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