The FDA says it wants to reduce tobacco harm, but its docket tells a different story: it has greenlit hundreds of new cigarettes while bottlenecking lower-risk alternatives. For the 480,000 Americans whom smoking kills each year, that’s failure. If protecting public health is the mandate, the FDA must expand approvals for lower-risk alternatives to smokers that give them a way to quit.
One of the first steps the agency can take is renewing authorizations for reduced-risk products which the agency has already vetted, including heated tobacco products (HTPs) now up for renewal. When the FDA first authorized HTPs the agency’s own review found that the aerosol produced by heating—not burning—tobacco contained far fewer toxic chemicals than cigarette smoke. Since then, the evidence has only strengthened: studies report roughly 90 percent lower levels of harmful and potentially harmful constituents (HPHCs) and 95 percent lower levels of known carcinogens compared with cigarettes.
Reduced toxins from HTPs have been observed in laboratory experiments. Smokers who switch exhibit sharp declines across numerous biomarkers of exposure. No tobacco or nicotine product is risk-free, but moving from combustion to heat—and away from thousands of smoke byproducts—is a clear step reducing the harm to smokers.
The same harm-reduction logic applies to vaping, which heats a nicotine-containing liquid rather than tobacco. For millions of adults, vapes deliver nicotine with fewer toxic chemicals than combustible cigarettes. And for many of those adults, flavors matter. Flavored vapes are an effective method of getting smokers to quit. Blanket flavor bans aimed at protecting the youth end up removing the very products that help adults quit. Nicotine must be kept out of kids’ hands. But if flavored vapes were attracting more children, youth nicotine use rates would be rising. Instead, they are falling.
Unfortunately, the regulatory playing field still tilts the wrong way. Between 2018 and 2022, the FDA authorized 892 new cigarette products. In its entire history, the agency has authorized only 45 “modified risk” products—i.e. harm reduction and smoking cessation products. That imbalance is hard to square with a public-health mission that should prioritize reductions in death and disease. Adult smokers deserve choices of lower-risk alternatives, yet too few harm-reduction pathways are available.
It isn’t entirely the FDA’s fault. While the agency should be held accountable for refusing to authorize many flavored products, Congress has also put them in a tough spot. Under the Family Smoking Prevention and Tobacco Control and Federal Retirement Reform Act of 2009 new cigarettes need only demonstrate “substantial equivalence” to a product that was on the market before February 15, 2007. This allows producers to skip the Premarket Tobacco Product Application (PMTA) entirely. That sets a low bar for cigarette approvals, reducing application cost and the risk of a new cigarette being rejected.
By contrast, lower-risk nicotine products have no “substantial equivalence” route. These products must complete a full PMTA and, to make any harm reduction claims, obtain a separate Modified Risk Tobacco Product order because they had no equivalent products on the shelf in 2007.
Making cigarettes easier to approve than smoking cessation tools was clearly not the intent of a law with “Family Smoking Prevention and Tobacco Control” in the title, but that is the practical effect until congress fixes it. Vapes, HTPs, and other harm reduction tools should have an avenue of approval comparable to cigarettes.
Congress should give the FDA both the authority and the mandate to adopt a broader strategy that meets smokers where they are and provides multiple ways to quit cigarettes. The agency should expand the authorization for vaping, HTPs, and other scientifically demonstrated lower-risk products, prioritizing applications that show large reductions in toxic chemicals and consistent manufacturing. The FDA also needs clear direction to recognize that flavored vapor products are critical for adults switching from cigarettes and that, unless the flavor itself is specifically chemically harmful, adults should be free to choose it.
The FDA’s mandate is to protect public health, but right now Congress must act to help it do so. That means prioritizing harm-reduction tools in the PMTA process. Congress and the FDA need to act to give American smokers practical, appealing ways to leave cigarettes behind. Every successful switch is a life made longer, and a health-care bill never sent.
Justin Leventhal is a senior policy analyst for the American Consumer Institute, a nonprofit education and research organization that advocates for consumers through evidence-based analysis and data. Visit www.TheAmericanConsumer.Org or follow us on X @ConsumerPal.
