The United States faces a host of public health challenges, including the opioid overdose crisis and pandemic preparedness. Cigarette smoking, however, remains the leading cause of preventable death in America. “Cigarette smoking causes more than 480,000 deaths each year in the United States,” the Centers for Disease Control and Prevent says.
Public polling indicates many American smokers say they want to quit using combustible cigarettes. Despite the existence of tobacco control policies and traditional cessation methods, 30.8 million adult smokers remain, many of whom have not tried to quit or have not quit successfully. For this population of smokers, a suite of safer nicotine alternatives such as e-cigarettes, nicotine pouches, snus, and heat-not-burn products may succeed in helping them quit where other policies have failed.
Traditional tobacco control strategies such as education, taxation, marketing restrictions, and bans on smoking in a growing list of public spaces have contributed to a gradual reduction in the smoking rate from its peak of around 40 percent in the mid-1960s to 12.5 percent today. Safer nicotine alternative products are a newer, yet crucial, component of a tobacco harm reduction strategy, giving those smokers who would not otherwise have quit a way to use nicotine without the smoke that may kill them. A substantial body of evidence demonstrates that these tools are more effective in helping smokers quit than traditional cessation methods, such as nicotine replacement therapies (NRTs), and are vastly less harmful to human health than combustible tobacco.
To maximize these products’ potential to help improve public health while limiting youth access and uptake, Congress, the U.S. Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) must ensure consumers have access to these products at reasonable prices and are accurately informed about their risk relative to cigarettes.
Millions of Americans have successfully switched from combustible cigarettes to safer nicotine alternatives. While the overall smoking rate has declined to a generational low, smoking remains disproportionately high among low-income communities, people without college degrees, and those with mental health problems.
A substantial barrier preventing greater uptake of safer alternatives to cigarettes is the widespread misperception among a majority of the public and physicians that these products are just as dangerous or more dangerous than combustible cigarettes.
For example, though the spate of lung injuries and deaths that occurred in 2019 were quickly linked to the proliferation of adulterated cannabis vapor products, public polling suggests a majority of adults attribute the outbreak to nicotine vapor products.
In Dec. 2022, a group of public health experts urged the CDC to correct rampant misinformation regarding the dangers of e-cigarettes. Speaking to the Associated Press in 2022, the Director of FDA’s Center of Tobacco Products (CTP) Dr. Brian King said there were widespread misperceptions around the use of e-cigarettes.
“I’m fully aware of the misperceptions that are out there and aren’t consistent with the known science,” King said. “We do know that e-cigarettes — as a general class — have markedly less risk than a combustible cigarette product.”
But, as of now, it appears the FDA has no plans to correct these misperceptions.
Congress can contribute to communicating clear and accurate information on the relative risks of noncombustible products and potential benefits for adult smokers who switch to these products. Unfortunately, the FDA and the CDC are currently falling short of this mission, and neither agency has outlined any plans to address the problem. It is the responsibility of Congress to hold both to account.
Reagan-Udall Foundation evaluation
After a series of missteps handling e-cigarette product applications, FDA Commissioner Robert Califf asked the Reagan-Udall Foundation (RUF) to evaluate the FDA’s tobacco program. RUF was established by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”
In Dec. 2022, the Reagan-Udall panel delivered its verdict on FDA’s performance. The report found several failings at the FDA, including opacity and confusion regarding the agency’s refusal to authorize safer nicotine products.
In 2009, Congress passed the Tobacco Control Act, which established a pathway for authorizing safer nicotine products, ensuring tobacco harm reduction could play some role in reducing smoking rates. But in practice, the process has created a functional barrier to entry for legitimate companies and products, costing vast sums of time and money per application and leaving applicants unsure of what materials they need to provide for a successful application. In the meantime, the vapor market, bereft of FDA-authorized options, has been flooded with illegitimate products in order to fill the vacuum.
In particular, RUF’s report called on the FDA to define what is “appropriate for the protection of health,” a central factor in determining whether to authorize new products. The evaluation also called on the FDA to develop and implement a comprehensive plan for the Center of Tobacco Products’ goals and priorities, greater transparency, engagement with industry stakeholders, clarity on when FDA decisions prioritize public policy or political concerns rather than the strength of the underlying science, removing illicit products from the market, and simpler processes for authorizing certain novel products that may benefit individual and public health. Congress should closely monitor the FDA’s efforts to implement RUF’s recommendations and, if it refuses to do so, investigate why.
Research shows e-cigarettes are substitutes, not compliments to traditional cigarettes. There are good reasons to tax combustible cigarettes, such as recouping costs to the health care system attributable to smoking-related diseases and discouraging youth smoking. But since noncombustible nicotine products, like e-cigarettes and other reduced-risk products, present significantly less danger to consumers and offer a net benefit to public health if smokers switch from cigarettes, sound public policy dictates that these products should be taxed at a significantly lower rate than cigarettes, if at all.
In the last Congress, there were attempts to introduce the first federal e-cigarette tax, which would’ve set the tax to be equivalent to the tax on cigarettes. According to modeling from Georgia State Univerity Professor Michael Pesko, the tax would have resulted in fewer adult e-cigarette users and an increase of 2.5 million more smokers than there would be otherwise. Taxing less harmful products at a level equal to or higher than the most deadly products provides a clear disincentive for smokers to switch, thus resulting in net harm to public health. Additional federal taxes on e-cigarettes and other harm reduction taxation tools would prevent a significant number of smokers from switching, harming public health, and should be resisted.
Innovation presents promising opportunities to improve public health and support small businesses. While the economic benefits are secondary to the public health benefits, in 2019, The Washington Post reported that vape shops were the fastest-growing U.S. retail segment of the previous decade. Unfortunately, many of these stores have already been forced to shut their doors over the past three years in large part due to the flood of misinformation about these products and the byzantine regulatory process the FDA has yet to fix.
A sound regulatory framework for safer alternatives to cigarettes would ensure these harm reduction options are available to the consumers who need them at reasonable prices while still limiting the access young people have to them. Ensuring the FDA and the CDC are supporting, rather than hampering this public health objective is a sure way Congress can bear down on the public health toll of smoking.