Wednesday, July 27, 2005

Vermont Sues R.J. Reynolds for False Health Claims

Vermont, aided by an investigation conducted by nine states and the District of Columbia, filed a lawsuit Tuesday against R.J. Reynolds, accusing the company of making false health claims in marketing its Eclipse cigarettes. The suit was brought on the basis of state consumer protection laws as well as the Master Settlement Agreement. Eclipse is a cigarette brand that apparently heats tobacco and does not burn it.

Vermont Attorney General William H. Sorrell outlined three advertising claims made by Reynolds' advertising for Eclipse that he argues are misleading and unsubstantiated:
  • “Scientific studies show that, compared to other cigarettes, Eclipse may present less risk of cancer, chronic bronchitis, and possibly emphysema.”
  • “Eclipse responds to concerns about certain smoking-related illnesses. Including cancer.”
  • “The best choice for smokers who worry about their health is to quit. The next best choice is Eclipse.”
Sorell stated that “There is no second-best choice to quitting and there is no evidence that Eclipse is any less harmful than any other brand of cigarettes available on the market. By suggesting that Eclipse is a safer cigarette, R.J. Reynolds is misleading smokers, former smokers and non-smokers about the health consequences of smoking Eclipse.”

In response, R.J. Reynolds Executive Vice President and General Counsel Charles Blixt was quoted as stating: "We have science that backs up every single claim that we've made. It's fully substantiated. We have conducted millions and millions of dollars worth of research. The scientific data we have clearly leads us and our panel of independent scientists to conclude this might lead to less cancer, bronchitis, emphysema."

The Rest of the Story

It is not possible to provide a definitive commentary because I may not be aware of all the scientific data that R.J.Reynolds has obtained to back up its advertising claims. However, the company has made available a summary of scientific data on Eclipse. Assuming this represents the bulk of the data upon which the company's advertising claims are based, here is my analysis.

The available data document that Eclipse produces significantly lower levels of a number of carcinogenic and toxic components of mainstream cigarette smoke compared to conventional cigarettes, and compared to low-tar and ultra-low-tar cigarettes. It also has lower in-vitro mutagenicity, lower tumorigenic activity in animal studies, and produces lower urine mutagenicity in humans.

However, the only relevant human study conducted was an analysis of urine mutagenicity. There are no epidemiologic studies to document any changes in disease rates, nor any human studies to document clinical changes, such as reductions in measurable levels of DNA adducts.

While Eclipse lowers the levels of many carcinogenic and toxic agents in mainstream smoke, it was also found to substantially increase levels of two chemicals: furfural, with levels 6 times higher than in conventional cigarettes, and acrolein, with levels similar to those in conventional cigarettes but 3 times higher than in ultra-low-tar cigarettes.

Based on these data, I do not see any adequate scientific support to make a claim that smoking Eclipse cigarettes will, or even is likely to, reduce the risks of chronic obstructive pulmonary disease or cancer. I also do not see any adequate scientific support to make a claim that switching to Eclipse is the next best choice to quitting smoking.

In short, I think there is a very strong case against R.J. Reynolds for false and misleading advertising that constitutes consumer fraud under most state consumer protection statutes.

But this story has a very important lesson in it for anti-smoking groups, especially those which are supporting FDA legislation which they claim would protect the public's health by authorizing FDA to require reductions in the level of tobacco smoke constituents.

The lesson is that we simply do not know enough about the relationship between the specific components of tobacco smoke, their amounts, their interaction, and the development of disease to be able to conclude that reducing the amounts of certain smoke components is going to prevent disease, save lives, and improve the public's health.

But these are precisely the claims that health groups like the Campaign for Tobacco-Free Kids are relying upon to support the FDA legislation and to argue that it is an important public health measure that will save lives.

The rest of the story reveals that the precise argument that I think is going to nail R.J. Reynolds for false and misleading advertising in this lawsuit is also going to nail the Campaign for Tobacco-Free Kids' claim that the FDA legislation is going to save lives by making cigarettes safer.

There simply is not any sufficient scientific documentation to claim that reducing the levels of certain constituents in tobacco smoke will reduce disease and save lives.

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