July 26, 2022—In June, the U.S. Food and Drug Administration announced plans to develop a proposed product standard by May 2023 that would establish a maximum nicotine level in combustible tobacco products and reduce their addictiveness. The same month, the agency ordered electronic cigarette company Juul to immediately stop selling its products in the U.S., but later suspended the order pending further review. And on July 13, the FDA announced that any new synthetic nicotine product that has not received premarket authorization from the agency cannot be legally marketed. Here, experts from Harvard T.H. Chan School of Public Health discuss the public health implications of these actions.
On the potential standard lowering nicotine levels
Howard Koh, Harvey V. Fineberg Professor of the Practice of Public Health Leadership: The historic product standard announcement creates critical forward momentum for a comprehensive nicotine-based tobacco regulatory plan FDA first pledged in 2017. The tobacco industry has long argued that use of their combustible products is about choice, not dependence, when of course the opposite has been true until now. Their cigarette products cause death in half of long-term users.
Having a marketplace featuring minimally- or non-addictive cigarettes with very low levels of nicotine could dramatically reduce addiction and associated suffering. Research models project that the new policy, when implemented, could prompt 13 million smokers to quit over five years, prevent more than 33 million youth and young adults from become regular smokers this century, and save more than eight million lives.
Vaughan Rees, senior lecturer on social and behavioral sciences and director, Center for Global Tobacco Control: Lowering nicotine in cigarettes to minimize their addictive potential makes good sense from a public health perspective. The evidence has shown that very low nicotine content (VLNC) cigarettes not only help to prevent young people becoming addicted but can reduce consumption and increase quitting in adult smokers.
There have been concerns that smokers who switch to VLNC cigarettes might puff more intensively or smoke more cigarettes to obtain the nicotine they need to satisfy their needs. This could result in an unintended consequence of even greater exposure to tobacco smoke toxicants. However, the evidence is clear that smokers who switch to VLNC cigarettes reduce their consumption and overall exposure to harmful tobacco smoke constituents, including certain carcinogens. Some smokers are finding that quitting is easier after transitioning from a VLNC product.
On decisions around regulation of Juul and synthetic nicotine
Rees: While the FDA is rightly working to protect a new generation of young people from becoming dependent on nicotine products, the decision to deny marketing authorization for Juul appears very shortsighted. Properly regulated, “clean” nicotine products, including Juul, have been shown to be a far less risky alternative to combustible cigarettes for adult smokers who have not been able to quit smoking. There are numerous strategies already in place to lower demand and restrict youth access to vaping products. However, removing a potentially life-saving option for some three million former adult smokers—while allowing combustible cigarettes to remain in the market—is not consistent with the principles of public health.
On the other hand, the attempt by some e-cigarette manufacturers to subvert FDA’s authority with synthetic nicotine product is a major concern. While synthetic nicotine products may not necessarily pose different health risks from other reduced exposure products, a lack of regulatory oversight of their sale and marketing, including health claims, could have serious consequences. Ultimately, Congress may need to update the law that provides FDA with its authority to regulate tobacco products by explicitly including synthetic nicotine.
Koh: Many scientific issues about Juul still need to be addressed so we await further FDA review. While a number of teens have moved away from e-cigarettes, it’s estimated that about two million youth in the U.S. use them over a 30-day period. Any action to protect kids from using e-cigarettes or any tobacco product during a vulnerable period of their lives will represent a major public health benefit.
On the way forward
Koh: I had the honor of attending, on my very first day as U.S. Assistant Secretary for Health in 2009, President Obama’s signing of the Family Smoking Prevention and Tobacco Control Act establishing the FDA Center for Tobacco Products. Since then, progress has been uneven and never easy. Recently however, the FDA is finally accelerating efforts for regulation of combustible products, like cigarettes, as well as non-combustible products, like e-cigarettes. Their actions regarding synthetic nicotine close a regulatory loophole that had existed until now. Moreover, along with the plan to move forward on a tobacco product standard for nicotine, the FDA recently announced major actions to ban menthol cigarettes and flavored cigars. Complicating all these issues, however, has been a tobacco industry publicly promoting the legitimate and critical concept of harm reduction while still producing combustible cigarettes that cause the harm in the first place. We need all forces to align together at this critical moment to save lives from a global pandemic that has gone on for far too long.
Rees: I am always optimistic about the potential for insightful scientists and policy makers to reduce the burden of tobacco-related disease. However, I am concerned that the FDA’s current stance on vaping products may unintentionally perpetuate disparities in tobacco-related harm. Although the prevalence of smoking has declined in the U.S., we have seen little change in smoking among marginalized groups.
I would like to see greater emphasis on a tobacco harm reduction approach, which would support adult smokers who are unable or unready to quit, to switch to reduced-exposure nicotine products. At the same time, regulatory authorities such as the FDA should continue to examine all possible options to regulate the features of combustible cigarettes that make them so deadly and work to transition to less deadly, smoke-free alternatives. Tobacco harm reduction has been adopted with success in the U.K., and the U.S. public—especially those who are at the highest risk of tobacco-related disease—deserve the opportunity to access properly regulated, low-risk alternative products, including vape devices.