Summer Reading: Tobacco Harm Reduction

As the summer heats up, heated debates about tobacco harm reduction (THR) have millions of consumers sweating. While smokers are desperately searching for ways to kick their deadly habit, policymakers have doubled-down on onerous restrictions that curtail the availability of reduced-risk products and fuel black markets. It’s time to turn down the thermostat and chill out with some cool-headed solutions and science, rather than misinformation and scare tactics.

THR products like vapes, pouches, and heated tobacco are—as the name suggests—less harmful alternatives to traditional cigarettes. More than 480,000 deaths occur annually in the United States from smoking. This amounts to about one out of every six deaths in the U.S. each year. A conventional cigarette contains more than 6,000 ingredients which, when burned, release more than 7,000 chemicals, many of them carcinogens, including arsenic, formaldehyde, lead, and tar. Unsurprisingly, traditional cigarette use is associated with a host of diseases and chronic illnesses. The National Cancer Institute notes, “Smoking harms nearly every bodily organ and organ system in the body and diminishes a person’s overall health. Smoking causes cancers of the lung, esophagus, larynx, mouth, throat, kidney, bladder, liver, pancreas, stomach, cervix, colon, and rectum, as well as acute myeloid leukemia. Smoking also causes heart disease, stroke, aortic aneurysm (a balloon-like bulge in an artery in the chest), chronic obstructive pulmonary disease (COPD) (chronic bronchitis and emphysema), diabetes, osteoporosis, rheumatoid arthritis, age-related macular degeneration, and cataracts, and worsens asthma symptoms in adults. Smokers are at higher risk of developing pneumonia, tuberculosis, and other airway infections. In addition, smoking causes inflammation and impairs immune function.”

Millions of Americans have used THR products to help them quit smoking. In 1965, according to the Centers for Disease Control and Prevention (CDC), 42 percent of U.S. adults smoked cigarettes. As of 2022, that percentage had fallen to 11.6 percent. From 2007 to 2015, more than three million U.S. adults used THR products to quit smoking cigarettes. Smokeless tobacco products, such as e-cigarettes or vapor products, release nicotine without these harmful effects. They have been proven to aid adults in quitting smoking and are highly likely to have been a contributory factor in the steep declines of combustible tobacco use in recent years. Yet, governments around the world are restricting access to THR products based on ideology or failure to recognize misinformation peddled by those with vested interests.

The World Health Organization (WHO) marked the 20th anniversary of its Framework Convention on Tobacco Control (FCTC) earlier this year. The FCTC is an international treaty, entered into force in April 2005, aimed at reducing tobacco use and its health impacts. Unfortunately, administrators of the treaty have focused more on outright bans and burdensome regulations on safer nicotine products than on efforts to reduce harm. As the Competitive Enterprise Institute noted in a 2018 letter, “The WHO should … be promoting the continued research and development of innovative products scientifically-substantiated to be of reduced harm as compared to combustible cigarettes. To date, the WHO has failed to adequately recognize that collaboration with all stakeholders and promoting new and innovative products can help reduce the harm associated with smoking cigarettes despite a considerable body of evidence to the contrary. The WHO’s position – or inaction – is also despite policies and statements from leading agencies like the U.S. Food and Drug Administration [FDA] and Public Health England, as well as the American Cancer Society.”

Tobacco policy worldwide is guided by decisions made by national delegations to the FCTC Conference of the Parties (COP) meetings, but these decision-makers are being misled by the FCTC Secretariat which has stubbornly renounced tobacco harm reduction and its benefits. Dismissing the potential of alternative nicotine delivery systems like e-cigarettes and smokeless tobacco not only limits further reductions in smoking but also causes an influx in black market activity which puts consumers at risk.

This is why the Taxpayers Protection Alliance is set to host Good COP/Bad COP, a conference to expose the WHO’s failure to accept the benefits of THR. Last year, the conference took place in Panama City, Panama, as the WHO FCTC met for their biennial COP event to discuss tobacco-related issues. TPA’s “Conference of the People (Good COP)” focuses on free market solutions and provides the opportunity for THR experts and consumers, often ignored by the WHO, to be heard during the discussion of tobacco and tobacco harm reduction. This year, the annual conference will be held in Switzerland. The coalition of taxpayers, free market experts, and harm reduction organizations will offer a counter perspective based on the truth about THR.

Every year TPA reviews CDC data on adult and youth tobacco and vapor product use, publishing these insights in our “Tobacco and Vaping: 50 State Analyses.” As noted earlier, smoking rates are down across the board in the U.S. This decline is particularly pronounced among younger adults, with the smoking rate among adults aged 18-24 years dropping from 21.7 percent in 2011 to 4.9 percent in 2022. Tobacco use among U.S. middle and high school students has dropped to a 25 year record low. According to the 2024 National Youth Tobacco Survey, 2.25 million middle and high school students reported current use (use on one or more days during the past 30 days) of any tobacco product, compared to 2.80 million in 2023.

To effectively reduce the use of combustible cigarettes in the U.S., the FDA’s Center for Tobacco Products (CTP) Premarket Tobacco Product Application (PMTA) must be streamlined. The FDA should adopt a balanced regulatory approach that promotes innovation in tobacco harm reduction while ensuring product safety, rather than imposing prohibitively high-cost barriers. By streamlining approval processes for less harmful alternatives like e-cigarettes and smokeless tobacco, the agency can provide consumers with accessible, less risky options and incentivize the development of safer products. New leadership in the FDA presents an opportunity to reform the convoluted PMTA process, which is burdensome, costly, and time-consuming. But, as TPA noted in its amicus brief on the Triton case filed at the Supreme Court in 2024, the FDA has regularly engaged in “regulatory switcheroos” that have harmed consumers and undermined public trust. This onerous and confusing process can cost more than $100 million and take five years or longer, even though CTP is supposed to decide on product applications within 180 days.

The FDA is overdue for much-needed reforms that would streamline the PMTA process, allowing the FDA to fast-track THR products. If a product has not been denied or approved within 180 days, it should be approved for sale and marketing (by default) to encourage CTP to meet its deadlines. Taxpayers and consumers deserve a fast and flexible process that gives smokers an exit ramp off a deadly and destructive habit.

Additionally, TPA will monitor the WHO and global governments, sharing insights from stakeholders at Good COP/Bad COP to highlight the critical challenges faced by the worldwide tobacco harm reduction community. This aims to foster greater awareness and advocacy for effective policies and innovation in THR efforts.