The Food and Drug Administration (FDA) is preparing to order Juul Labs Inc. to take its e-cigarettes off the U.S. market. This comes on the heels of a similar April denial order for the myblu vaping device. It seems the FDA is determined to eliminate e-cigarettes from the marketplace altogether.
President Biden granted the FDA the authority to regulate products containing non-tobacco synthetic nicotine on March 15, 2022 by signing the Omnibus budget bill H.R. 2741. The new legislation amended the definition of a “tobacco product” requiring manufacturers of all currently marketed synthetic nicotine products to submit a Premarket Tobacco Product Application to ensure that their products could remain on the market. Synthetic nicotine products that do not receive authorization by July 13, 2022 and remain on the market would be in violation of the statute. Out of the more than six million applications received thus far, the FDA has approved exactly two device brands.
The FDA’s decision to remove these cessation devices from the market will have a devastating impact on public health, leading to an increase in preventable death and disease. In a recent clinical trial researchers found switching entirely to Juul reduced smokers’ exposure to biomarkers by 99.6 percent as much as abstaining entirely from cigarettes. However the FDA is ignoring the science and choosing to block responsible adult users from accessing viable alternatives to regular tobacco products such as Juul and other e-cigarettes which have been proven to reduce the risk associated with traditional cigarettes.
As NTU has previously detailed, the percentage of American cigarette smokers has dropped by nearly half in the last twenty-five years, falling from 25 percent of adults down to 13.7 percent. E-cigarettes are a proven harm reduction product and an effective tool for adult smokers who want to reduce or quit their habit. According to a New England Journal of Medicine study, smoking cessation is two times more likely to occur in those who used e-cigarettes compared to using other nicotine replacement products.
The FDA recently stated they are working toward “Envisioning a world…where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts” while “striking a balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes.” Yet its recent actions are directly at odds with the FDA’s admission that e-cigarettes are less harmful and a useful tool to reduce traditional tobacco use and potential harm.
The FDA should exercise discretion in its enforcement and allow e-cigarettes companies that have filed the appropriate applications and have met the required metrics to remain in the marketplace. Instead the FDA is determined to pick winners and losers when they should be focused on traditional harm reduction strategies that have worked to reduce usage in youth or underage smokers and allowed responsible adults to make their own decisions.