Friday, May 27, 2005

New Research Suggests FDA Tobacco Regulation Would Be Enormous Victory for Philip Morris

An article published in the current issue of Tobacco Control, released today, examines the reasons for Philip Morris' support of FDA regulation of tobacco products, using internal industry documents. (See: McDaniel PA, Malone RE. Understanding Philip Morris' pursuit of US government regulation of tobacco. Tobacco Control 2005; 14:193-200).

The article's main findings are that:
  • "Philip Morris’s support for government regulation of tobacco is part of a broader effort to address its negative public image, which has a damaging impact on the company’s stock price, political influence, and employee morale."
  • "Through regulation, the company seeks to enhance its legitimacy, redefine itself as socially responsible, and alter the litigation environment."
  • "Whereas health advocates frame tobacco use as a public health policy issue, Philip Morris’s regulatory efforts focus on framing tobacco use as an individual choice by informed adults to use a risky product. This framing allows Philip Morris to portray itself as a reasonable and responsible manufacturer and marketer of risky products."
The authors conclude that: "Philip Morris’s ability to improve its image through support of FDA regulation may undermine tobacco control efforts aimed at delegitimising the tobacco industry. It may also create the impression that Philip Morris’s products are being made safer and ultimately protect the company from litigation."

The Rest of the Story

This article is important because it helps explain the reasons underlying Philip Morris' support of the FDA tobacco legislation that is currently being considered by Congress. Based on the company's reasons for supporting the legislation, Philip Morris clearly believes that passage of H.R. 1376/S. 666 would have a number of beneficial effects on its bottom line:
  • improvement of its public image by supporting federal regulation, although limited regulation, of its products;
  • undermining of public health efforts to de-legitimize the industry and its practices;
  • improving the public image of smoking itself by enhancing the framing of tobacco use from a public health problem to an issue of individual choice;
  • helping to promote a belief among the public that cigarette products are being made safer, even when there is not evidence to support such a belief; and
  • helping to protect the company from significant damages in ongoing and future litigation.
This new evidence, taken directly from the nation's chief tobacco company, supports the conclusions of my analysis of the likely effects of the FDA legislation. The chief effects of the legislation, as I have outlined, parallel very closely the conclusions of Philip Morris regarding the most critical outcomes of the legislation that the company foresees:
  • First, it would create an FDA "stamp of approval" for tobacco products, which would likely decrease the public's perception of the inherent harm of tobacco products. By officially sanctioning the products, the government would be giving the public a false perception of a level of safety.
  • Second, it would create a perception that the tobacco problem has been taken care of, and no further interventions are necessary. It would become almost impossible to convince state legislators, for example, to allocate substantial funds for tobacco control once FDA is given authority to regulate the product.
  • Third, it would essentially end tobacco litigation, by allowing the cigarette companies to argue (correctly) that they have already submitted to FDA regulation and so no further punitive or injunctive relief is required. If this legislation is enacted prior to the resolution of the DOJ tobacco lawsuit, it will completely decimate that lawsuit.
  • Fourth, it would produce an enormous amount of goodwill for the tobacco companies by enabling them to tell the public (accurately) that they now fully comply with a comprehensive system of federal regulation of their products.
Importantly, the article reveals that Philip Morris sought to include in the legislation a distinction between "reduced risk" and "reduced exposure" products. As the authors conclude: "This would allow PM (and other tobacco companies) to market reduced exposure cigarettes based on an initial determination that they exposed smokers to fewer toxins." But this marketing would essentially be done without substantiation of any health benefits. Consumers would likely interpret the reduced exposure claim to imply a health benefit. Thus, the legislation would institutionalize the very problem of misleading health claims that groups like the Campaign for Tobacco-Free Kids have argued are the very reason for the need for this legislation in the first place.

In summary, the rest of the story reveals that the proposed FDA legislation would be a huge victory for Philip Morris and an equally huge loss for the public's health: the company's public image, litigation risks, and ultimately, its bottom line would improve at the expense of a decreased appreciation of the health risks of smoking, a false sense of public security over the health risks of tobacco products, and an elmination of the possibility of justice for victims of tobacco industry products.


benpal said...

A very good analysis. What it shows is that PM has learned to play the game on their enemy's battlefield. And it also indicates clearly that when the FDA takes over legislation of a product like tobacco, the FDA also takes over accountability and responsibility of its effects. Will the future bring class actions and lawsuits against the FDA instead of the tabacco industry, on the grounds that the FDA "legalizes" a harmful product?

Mac said...

Could someone---anyone who knows---clear something up for me?

I am a smoker who has avoided Big Tobacco products for over six years. (I have smoked since 1988.) I've found from personal experience that "natural" tobacco (i.e., tobacco without additives) is much less habit-forming and causes much milder withdrawal symptoms than Big Tobacco's products.

As I have read in the BMJ and elsewhere, Big Tobacco adds toxic substances such as ammonia to their cigarettes. These additives supposedly heighten the stimulant properties of nicotine; also, by means of toxic accumulation, they increase the user's craving for stimulants, causing him to smoke more cigarettes. Lord knows how much long-term harm they inflict.

My question is, wouldn't FDA regulation put a stop to this? Wouldn't it effectively make all cigarettes "additive-free" cigarettes? And wouldn't this be a good thing?

Michael Siegel said...

The legislation would give FDA authority to eliminate or reduce the levels of ingredients, components, and additives of cigarettes and cigarette smoke. However, it cannot require changes that result in what amounts to essentially banning an entire type of tobacco products (such as conventional cigarettes) and it cannot require the elimination of nicotine in cigarettes. And, any major rule (such as one making cigarettes less addictive) would be subject to Congressional approval.

So there is no guarantee that FDA would do anything to require that cigarettes not be made in a way that makes them addictive. And even if FDA wanted to do something, it is not clear that the legislation would allow the Agency to take the necessary action without Congressional approval.