A New Cigarette Every Two Days, But No Vapes
The FDA does not have smokers’ best interests at heart. While nearly half a million Americans die each year from smoking-related causes, the agency continues to deny smokers access to harm reduction tools that could prevent many of those deaths. It has authorized almost 180 new cigarette products each year on average—almost one new cigarette every two days—while only approving 23 vaping products total, despite strong evidence that vaping is both far less harmful than smoking and one of the most effective tools smokers use to quit.
Congress requires the FDA to permit new cigarettes if they are “substantially similar” to products that were on the market before 2007. But no such obligation exists for modern, lower-risk technologies. The Family Smoking Prevention and Tobacco Control Act (TCA) of 2009 allows cigarette manufacturers to bypass full scientific review so long as the new product is similar to a pre-2007 brand. Newer reduced risk products like vapes must clear the far more onerous Premarket Tobacco Product Application process, including a full scientific review.
The FDA has exploited this asymmetry to bottleneck vaping products—even though vaping is estimated to cause 95 percent less harm than smoking. The difference in risk is large and obvious. While the FDA has been denying American smokers this tool to quit, the U.K. gave one million vapes to smokers to help them quit.
And the evidence is clear that vaping helps smokers quit. In the U.K. vaping has been credited with helping 50,000 smokers quit in 2017 alone. Studies show it also increases the effectiveness of other smoking cessation tools like counseling. Systematic reviews of scientific literature consistently support vaping as effective tool for quitting smoking.
So, if vaping is less harmful, proven to help smokers quit, and eligible for authorization under the FDA’s standard—that a product must be “appropriate for the protection of public health”—why is the FDA blocking it?
The agency claims that any benefits to adult smokers are outweighed by the risks to youth. This argument is absurd. The FDA cites “alarming levels of youth use,” But the rise in youth vaping coincided with a collapse in youth smoking, and total youth nicotine use is declining. Youth smoking rates are at a decade low, and youth vaping is falling too.
The result? The FDA is protecting no one. Smokers are forced to guess which products might have passed the same safety standards as the few approved products, and which is a knock off or is legitimate. Consumers are left in the dark. Instead of promoting health, the FDA is obstructing it—leaving smokers without safer options.
Since the FDA has failed to act, the solution must come from either the President or Congress. President Trump could direct the agency to revise its approval standards to reflect evidence. Alternatively, Congress could amend the TCA to remove the outdated 2007 cutoff and allow modern products to qualify if the are as safe as what the FDA has already approved.
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.
