FDA continues to vilify the wrong guy
Thirty years ago, as a young public health researcher and professor, I would begin my lectures by telling students that 480,000 Americans die from cigarette smoking every year, making it the leading cause of preventable death.
Sadly, 30 years later, I still begin my talks with the same fact. In those 30 years, 15 million Americans have died unnecessarily from cigarette smoking. To change this trajectory, it is time for the FDA to embrace bold, new thinking, including offering smokers safer nicotine-containing alternatives.
It’s almost impossible to comprehend that 15 million people have been lost over the past 30 years to cigarette smoking. To many of us, these people are nameless and faceless. In fact, the majority tend to be people of color, those from lower socioeconomic status, those with dual addictions and those with co-occurring mental health disorders. Those without a voice.
The historical Tobacco Control Act, passed in 2009, was supposed to be a tipping point and set the stage to save millions of lives. Unfortunately, it has not lived up to that promise. Many of the FDA’s initiatives, like graphic warning labels, are stalled in courts. Other FDA proposals will likely take years to play out. The menthol ban has yet to occur, even though it was first considered in 2011. And while FDA has finally proposed a ban on menthol this year, that too will likely be delayed in the courts (though I think that will be a losing battle for the industry).
Another recent proposal by the FDA to establish a maximum nicotine level in cigarettes will likely not produce the results FDA wants. The concept here is to establish a cap on nicotine in cigarettes so that they are no longer addictive. This is not a new idea. Twenty-eight years ago, scientists proposed establishing a nicotine threshold for addiction. Since then, we have learned a lot more about nicotine and have conducted additional studies using reduced nicotine cigarettes. In fact, one company, 22nd Century, is test-marketing a reduced nicotine cigarette called VLN (very low nicotine).
To date, sales have been “modest.” That is not surprising, as such low levels of nicotine will significantly alter a smoker’s experience. If we accept that a smoker primarily uses cigarettes for nicotine, then it is hard to believe that smokers would buy a product that does not meet their needs. One might conclude that is good — they would then quit smoking cigarettes. Is it that simple? While I tend to think the tobacco industry often exaggerates the black-market concept, in this case, I think it is a very real concern. And who would use these black-market products? People of color and lower socioeconomic populations. There would likely be a robust nicotine market that is not regulated, not taxed and possibly adulterated.
To make real and meaningful progress in addressing the tremendous toll of cigarette smoking, it’s critical that the FDA authorize lower-risk nicotine products, such as e-cigarettes and nicotine pouches, alongside a portfolio of approved smoking cessation medications.
Dr. Jasjit Ahluwalia – Washington Times – 2022-07-28
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