Wednesday, May 04, 2005

FDA Tobacco Regulation: Opportunity or Diversion for the Next Decade?

At an opening round session at the 2005 National Tobacco Control Conference in Chicago this morning, more than 100 tobacco control practitioners gathered to take part in what was perhaps the first public discussion of the proposed FDA tobacco legislation among grassroots public health advocates. Based on a critical evaluation of the FDA legislation by a panel of expert medical and public health researchers and practitioners, there was a general consensus that enactment of this legislation would have a substantial detrimental impact on the public's health and that the bill is therefore an inappropriate public health measure that we in tobacco control should not support. The panel concluded that rather than being an opportunity for progress, the bill is a diversion from what tobacco control organizations should be doing.

I opened the session by outlining the benefits and costs of the proposed legislation:


On the benefit side, the bill would require larger and stronger warning labels on cigarette packages and advertisements. However, there are no other significant benefits.

While some have argued that the bill would help curtail tobacco advertising and marketing to youths, it is unlikely that any substantial restrictions on cigarette advertising would meet the requirements set out by the Supreme Court for complying with the First Amendment's protection of free speech.

While some have argued that requiring disclosure of ingredients and smoke constituents along with giving FDA the authority to set performance standards that eliminate specific constituents would save lives, I pointed out that there is no evidence that removing a few of the more than 4000 chemicals and more than 40 carcinogens would result in a safer product. I also pointed out how absurd such an approach is from a public health perspective.

Finally, while some have argued that the modified risk section of the bill would prevent the marketing of potential reduced exposure products without adequate substantiation and enhance the availability of true reduced risk products whose health benefits are substantiated, I pointed out that the language of the bill actually makes it easier for companies to make a reduced exposure claim with almost no substantiation of health benefits and that the bill essentially puts an end to any possibility of truly reduced risk products by creating an impossible set of standards that such a product must meet.


The bill would have a number of substantial deleterious effects:

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.

In addition, the bill contains loopholes that would make it impossible for FDA to set any truly meaningful performance standards, allow the tobacco companies to tie up in court for years any attempt to require the removal of nicotine from cigarettes, preclude FDA from increasing the age of purchase for tobacco or banning the sale of tobacco in any specific type of retail establishment, and give Congress the ability to overturn any FDA rule that it doesn't like within 60 days, using a short-circuited legislative process that makes it easy, rather than difficult to overturn scientifically-justified regulations solely on political grounds.

A summary of my presentation is available.

Bill Godshall, Executive Director of Smokefree Pennsylvania, followed by focusing on the issue of harm reduction, concluding that the proposed FDA legislation would prevent potentially useful public health approaches to harm reduction in tobacco control.

Dr. Michael Cummings, Senior Research Scientist at Roswell Park Cancer Institute, then pointed out that the FDA legislation focuses on tobacco product toxicity, rather than on how product design changes may influence smoking behavior. True benefits from any regulatory approach would come not from performance standards, he said, but from product design requirements that would lead to decreases in cigarette consumption and smoking prevalence.

Finally, Dr. Alan Blum, Director of the Center for the Study of Tobacco and Society at the University of Alabama, presented a brief history of FDA regulation of pharmaceutical products and questioned whether given the FDA's dismal record in that area, the FDA is an agency that we want to be entrusted with regulation of the nation's most hazardous consumer product in the first place.

The Rest of the Story

The tragedy of this story is not in what happened, but in what did not and is not happening. The major organizations supporting the FDA tobacco legislation, including the Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, and American Lung Association, have consistently failed to enter into a dialogue with the public health community on the serious flaws, limitations, and costs of the FDA legislation that I and others have brought to their attention and to the attention of the tobacco control community at large.

According to at least one conference participant at the session, the approach of these organizations has been to simply cast off these criticisms of the legislation as coming from one "misinformed" individual. But there has yet to be any serious attempt to address the substantive issues raised.

There are only two possible reasons I can think of for why these organizations refuse to acknowledge these issues and to entertain any discussion about them, and I do not know if either is correct.

One possibility is that they realize they are wrong and have made a huge mistake in offering to make these concessions to Philip Morris, but are hoping that they can get away with it and can distract enough tobacco control practitioners at the grassroots level so that they will not be questioned in a way that could threaten the deal that has apparently been agreed to. This is actually the better of the two possibilities I can think of.

Another possibility is that they actually believe they are right. But if that is the case, then it is inexcusable that they would not be willing to enter into a discussion of these serious issues with their constituents. After all, they do not run the movement. We are all supposed to be part of the movement, and I think all of us have the right to have our concerns addressed.

Well, after today, one thing is for sure. We're not talking about one "misinformed" individual. There are more than 100 public health practitioners out there who are well aware of what this bill would do and what it would not do. It is going to be increasingly difficult for the Campaign for Tobacco-Free Kids to deflect continued criticism of its support for this legislation by casting the criticism as coming from one individual. And if reading the bill in its entirety constitutes "misinformed," then perhaps that may be a clue as to what the Campaign wants: blind followers who will take their word for the efficacy of the legislation but not dare read the actual bill to find out the true dangers that lurk beneath.

No comments: