- - Monday, August 20, 2018


Millions of cigarette smokers want to quit but are unable to.

The good news is, based on significant research, there are new and less harmful nicotine delivery products, such as e-cigarettes, which could help them give up tobacco and its health dangers.

The bad news is Congress and the Food and Drug Administration are denying them access to these products.

In 2016, the FDA finalized a rule that will, in effect, prohibit the sale of many alternative products including e-cigarettes. It requires the products to go through the costly and burdensome pre-market tobacco-application process. That’s a barrier that, once enforced, will jeopardize the continued existence of these products and may encourage former smokers who now use these alternative products to go back to cigarettes.

The FDA may not have much discretion on this specific rule. Congress, in passing the Family Smoking Prevention and Tobacco Control Act, arguably and possibly unintentionally made it more difficult for companies to bring less harmful alternatives to the market than to make new cigarette products.

Congress and the FDA need to take action that will allow smokers to have access to these products in a timely and reasonable manner. This involves embracing tobacco harm reduction.

Tobacco harm reduction is the simple idea that there are major benefits to letting smokers switch to less harmful means of getting their nicotine. This does not mean these alternative products have zero risk, but they do appear to have less risk than smoking cigarettes.

For example, in the most comprehensive government report of its kind, Public Health England concluded that e-cigarettes were 95 percent less harmful than tobacco cigarettes.

In 2017, the FDA embraced tobacco harm reduction, explaining that “a key piece of the FDA’s [regulatory] 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.”

Unfortunately, the FDA’s actions have been inconsistent with this important announcement. For example, the FDA is taking too long to give the green light for the sale of heat-not-burn tobacco products that have significant potential to be a popular less harmful alternative to cigarettes.

The FDA is also diverting its attention from getting these products onto the market and instead proposing extreme government intervention that would force smokers to stop smoking cigarettes. Specifically, the FDA has proposed trying to reduce nicotine in cigarettes to nonaddictive or minimally addictive levels.

If that were to happen, it would be, for all practical purposes, a ban on cigarettes.

Most smokers are addicted to nicotine and will likely find ways to get their nicotine in some manner, such as through the black market. They might choose to smoke even more cigarettes to get their nicotine fix, creating additional health problems.

Even if viable alternatives did exist on the market, some smokers would still find such alternatives to be ineffective to help them stop smoking. As it is, the FDA and Congress are not making it possible for smokers to have access to these alternatives.

The government’s regulatory strategy on alternatives to traditional cigarettes should not be complicated.

The market is providing potential solutions to one of the biggest public health problems. All the government has to do, in general, is nothing. As a result, the health of many smokers across the country will vastly improve.

This is not to diminish reasonable concerns, such as seeking to limit the use of these products by children. However, these alternative products can be made available to smokers while addressing any legitimate concerns that might exist, including conducting appropriate follow-up research. To do otherwise would be a classic example of “throwing the baby out with the bath water.”

Congress and the FDA have the chance to do the right thing by allowing smokers to have options to quit smoking. This should not be a difficult decision.

Daren Bakst is the senior research fellow for agricultural policy for the Heritage Foundation’s Roe Institute for Economic Policy Studies.

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