In an apparent philosophical shift, the Food and Drug Administration is taking a new tack when it comes to tobacco regulation: It is embracing the strategy of tobacco harm reduction.
New and innovative products, such as e-cigarettes, can deliver nicotine at far lower risk than combustible cigarettes. But these products had been threatened by FDA regulations issued last year that would have made it difficult for such products to remain on the market.
The FDA is now extending the deadlines for these existing regulations. The FDA also announced:
A key piece of the FDA’s approach is demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes. … The FDA is committed to encouraging innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes.
This is a very positive development. As The Heritage Foundation has argued, the federal government should embrace tobacco harm reduction, a strategy that recognizes that reducing the harm from the delivery of nicotine should not be an all-or-nothing proposition.
Generally, though, across the federal government there has been hostility to allowing the market to provide less risky alternatives to smoking.
This needs to change, as a recent Heritage Foundation paper explained:
Congress and the Trump administration can both help smokers move away from smoking and lower regulatory burdens by embracing tobacco harm reduction as a preferred strategy. This requires no government interventionist policies. Instead, the federal government simply needs to step aside and allow the market to make it possible for smokers to have access to innovative products that can help them stop smoking.
The FDA now looks like an agency that has embraced tobacco harm reduction and isn’t going to get in the way of private solutions that could be critical for the well-being of existing smokers and former smokers who are using these important alternatives to smoking.
The FDA also announced that it “plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards.”
The agency further stated, “lowering nicotine levels could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit.”
If the FDA does plan to move in this direction, then it would be even more imperative that a wide range of lower-risk alternatives to combustible cigarettes be available to the public without the federal government getting in the way.
Even though e-cigarettes may appeal to some existing smokers, they don’t appeal to all current smokers. Products such as “heat-not-burn” products that don’t pose the level of risk of combustible cigarettes need to be allowed on the market in a very timely manner.
Also, in addition to feasibility concerns, there may be unintended consequences of lowering nicotine levels in combustible cigarettes that would need to be carefully thought through.
For example, even if many alternatives did exist on the market, there inevitably would be some existing smokers who simply wouldn’t quit smoking by using these alternatives. Therefore, it wouldn’t be surprising if a black market developed in combustible cigarettes that contained higher nicotine levels.
Overall though, the FDA’s decision to embrace tobacco harm reduction is a great development for individuals who are trying to quit smoking. It is a critical change that could have the potential to save lives.
