Tuesday, April 7, 2015

FDA Must Correct Snus Warnings

An FDA advisory committee is meeting this week to discuss a landmark proposal to correct federal health warnings that have been misleading the public for almost 30 years.
Swedish Match, a manufacturer of the Scandinavian smokeless product called snus, petitioned the FDA to eliminate two package warning labels concerning mouth cancer, gum disease and tooth loss.  The company submitted numerous scientific studies documenting that these warnings, mandated in 1986, misrepresent the facts.
The mouth cancer warning was based on a flawed 1981 study of powdered dry snuff, an obscure product.  The reported cancer risk was far lower than from smoking, but it was incorrectly represented as high, and applicable to all American smokeless products (here and here).  In fact, numerous epidemiologic studies document that users of American moist snuff and chewing tobacco, and Swedish snus, do not have significantly elevated mouth cancer risk.

The gum disease/tooth loss warning is also unfounded.  There is no credible scientific evidence that smokeless tobacco is an independent risk factor for any dental problem.

Swedish Match has also urged the FDA to replace another 30-year old deceptive warning, “This product is not a safe alternative to cigarettes,” with this: “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”  The replacement warning is identical to a change requested by RJ Reynolds four years ago in a citizen petition filed with the FDA.  The agency ignored that petition.
The not-a-safe-alternative warning is particularly egregious, as I note in my book, “For Smokers Only” (here).  Accompanied by an incessant campaign for tobacco prohibition by government agencies and anti-tobacco extremists, the warning, appearing on packages and in advertising, has deceived millions of smokers.
The current warnings have been shown to discourage smokers from switching (here).  The proposed label would set the facts straight.  Numerous studies (reviewed here) document that the health risks of smokeless tobacco use are so low as to be barely measurable, even for mouth cancer.  (The European Union removed warning labels for that disease from Swedish snus packages in 2001.)  Statistically, smokeless users have about the same risk of dying from their habit as automobile users have of dying in a car accident.
Swedes have a history of embracing harm reduction. They invented the modern seat belt, and they’ve eagerly substituted relatively safe snus for cigarettes.  Snus use is directly associated with low smoking rates in Sweden, where men have smoked less and used more smokeless tobacco than in any other developed country.  The result: Swedish men have the lowest rates of lung cancer -- indeed, of all smoking-related deaths -- in the developed world.  If men in the rest of the EU smoked at the rate of Swedish men, there would be over one-quarter-million fewer dead smokers in the EU each year. (here).  Inexplicably, the EU has banned snus in every country except Sweden, denying smokers this life-saving option.

The good news is that snus is now widely available in the U.S. (as are e-cigarettes, another safer-than-cigarettes option).  A 2006 study funded by the National Cancer Institute (here) estimated that four million American smokers would switch to snus if they were informed about the vastly lower health risks of that product.  Research shows that smokeless tobacco (here) has already helped many smokers quit deadly cigarettes.

With no good science behind them, anti-tobacco extremists have resorted to scaremongering.  Dr. Michael Steinberg, director of the Tobacco Dependence Program at Rutgers, recently told NPR this convoluted story:

“If you imagine a young person who sees on a label that this is a less harmful tobacco product, they may interpret that as, ‘Oh, this is not harmful at all. I might as well try it and see what it's all about.’  And that person can still become addicted to the nicotine effects, which could either lead to them becoming a long-term smokeless tobacco user, or could escalate to them starting to smoke cigarettes.”

The FDA cannot take action based on fantasy scenarios.  Swedish Match’s request is scientifically sound.  Revised labels will tell the truth about snus, giving U.S. smokers life-saving information.

1 comment:

Jeff Andreoli said...

When will the FDA's decision be revealed?