Wednesday, November 2, 2011

FDA Petition: End Smokeless Tobacco Misinformation

The federal government requires the printing of three fallacious warnings on smokeless tobacco (ST) products . As I noted in an earlier post (here), one of the warnings – “This product is not a safe alternative to cigarettes” – is especially deceptive; it implies that smokeless tobacco is just as dangerous as smoking.

On July 28, RJ Reynolds filed a citizen petition with the FDA, challenging this warning (here). Reynolds requested that the agency change the text to:

“No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”

The petition states, “the public has been misinformed by the public-health and tobacco-control communities – including government health agencies – about the relative risks presented by cigarettes and ST products. A significant part of that affirmative misinformation is the challenged warning, which has appeared in other contexts before its inclusion in the [Tobacco Control Act] in 2009. Government-mandated warnings on ST products reach audiences beyond the purchasers of these products, through press reports, websites of and publications by organizations that follow the Government’s lead, word of mouth and otherwise. The challenged warning has been on ST products since February 1987, undoubtedly, it has contributed to the widespread misunderstanding, including among smokers, that ST products present as much risk to health as cigarettes do.

“FDA should not participate in further perpetuation of that misinformation by retaining the text of the challenged warning. When advising the public, and when requiring others to advise the public, about the relative risks of cigarettes and ST, the Government should, in suitably brief form, tell the whole truth, not mislead by telling only part of the truth.”

The petition documents, with scientific and legal evidence, the inaccuracy of the warning, which has been required since 1987. One of the strongest arguments is that it perpetuates the common misperception, documented in several published studies (including ours, here), that ST is equally or more dangerous than cigarettes. As a result, the warning “may lead some consumers to simply continue smoking after failed attempts at abstinence because they will be resigned to the belief that the use of [ST products] is just as harmful as smoking.”

The petition notes that the 2009 Tobacco Act gave the FDA authority to change the warnings in order to “promote greater public understanding of the risks associated with the use of smokeless tobacco products,” while “the current misleading warning affirmatively fosters public misunderstanding of those risks.” (Emphasis in original.)

I have lectured on tobacco harm reduction for over 17 years; one of the most common objections from opponents is that Americans can’t handle the truth that the health risks of smokeless tobacco are barely measurable. Because consumers might make bad decisions, health professionals are encouraged to perpetuate a lie.

The Reynolds petition destroys this specious argument. Its concluding paragraphs are exceptionally powerful, so I reproduce them here:

“One way or another, sooner or later, the public will learn the truth about the relative risks presented by cigarettes and ST products. When that truth becomes widely known, what will the members of the public think of the public-health authorities who had deceived them into believing that there is no relevant difference between the risks presented by cigarettes and those presented by ST products? And how much will their trust in public-health authorities on other matters – e.g. diet, exercise, alcohol – have been undermined by the deception about tobacco?

“[Sissela] Bok’s overall conclusion [from the book, Lying: Moral Choice in Public and Private Life, here] is that, for many reasons, lying to provide a benefit for the recipients of the lie is wrong. Her final words are: ‘Trust and integrity are precious resources, easily squandered, hard to regain. They can thrive only on a foundation of respect for veracity.’ For FDA, an agency whose mission is to be accomplished through the application of sound scientific principles and whose statutory charge here is to promote the greater public understanding of the risks associated with the use of ST products, there can be only one answer. Tell the whole truth.”

The Reynolds petition is scientifically credible and morally compelling. The FDA must correct the egregious misinformation that it requires on one fourth of all ST products sold in the U.S.

5 comments:

Anonymous said...

2 1/2 years ago I quit a 40 year smoking habit with smokeless tobacco (Swedish snus). I have no doubt if I hadn't been so misinformed about smokeless tobacco I would have switched a long time ago, very likely decades.

Good on RJ Reynolds to try and get the truth out to the public. This is information that can greatly improve public heath. Not sure how much faith I have in the FDA but I hope some sanity is restored to tobacco debate.

Alan Selk said...

2 1/2 years ago I quit a 40 year smoking habit with smokeless tobacco (Swedish snus). I have no doubt if I hadn't been so misinformed about smokeless tobacco I would have switched a long time ago, very likely decades.

Good on RJ Reynolds to try and get the truth out to the public. This is information that can greatly improve public heath. Not sure how much faith I have in the FDA but I hope some sanity is restored to tobacco debate.

zakezuke said...

This is one thing that makes me ill. I totally would have tried smokeless tobacco instead of automatically relapsing to cigarettes had I known the relative health risks. If the risk of cancer was identical, and everyone in this country used old skoal, tobacco related deaths would be cut by 30%. But the risks are not equal, even the FDA's leading expert
Neal L Benowitz concedes to a lack of increase in common cancers among lifelong smokeless tobacco users. Thus any concern of a net increase in smokeless tobacco use, so long as there is a decrease in cigarette use, is a huge net win for public health even if the increase reaches 100%.

http://www.fda.gov/downloads/Drugs/NewsEvents/UCM232147.pdf

zakezuke said...

This is one thing that makes me ill. I totally would have tried smokeless tobacco instead of automatically relapsing to cigarettes had I known the relative health risks. If the risk of cancer was identical, and everyone in this country used old skoal, tobacco related deaths would be cut by 30%. But the risks are not equal, even the FDA's leading expert
Neal L Benowitz concedes to a lack of increase in common cancers among lifelong smokeless tobacco users. Thus any concern of a net increase in smokeless tobacco use, so long as there is a decrease in cigarette use, is a huge net win for public health even if the increase reaches 100%.

http://www.fda.gov/downloads/Drugs/NewsEvents/UCM232147.pdf

wdstckdr said...

In Medical school the equivalency of tobacco risk was always promoted as uniformly equal. Although I do recall one of the pathologists stating that pipe smokers that didn't inhale did have a lower lung cancer rate. He did mention that lip, tongue and uvular/tonsillar tumor rates were higher. When I did the math on the percentage of pipe and cig users and the cancer mortality- damn anything smokeless beat both of them. Pipes were safer than cigs, but not the Skoal and Snuff users. Mentioned that in the next lecture and was informed that there were statistics, but uncontrolled ones and that if I ever told a patient that I might be looking at malpractice. that was 35 years ago. We come a long way baby... sad thing is I was a smoker then and would have switched to smokeless- but couldn't stand spitting. Vaping finally has saved me- but my wife still does a little SNUS now and then. Sanity and FDA- oil and water.