The Food and Drug Administration (FDA) has ordered JUUL, a prominent company, to stop selling e-cigarette products.  The June 23, 2022 decision was made because the FDA determined that JUUL did not submit an appropriate premarket tobacco product application (PMTA), submitting “insufficient and conflicting” data. The decision to immediately halt JUUL from selling tobacco harm reduction (THR) products in the U.S. was based on ensuring public safety, according to the FDA.  

FDA Commissioner Robert M. Califf stated, “Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards.”

Juul Labs chief regulatory officer Joe Murillo stated that the company believes it submitted proper evidence to meet FDA standards: “We respectfully disagree with the FDA’s findings and decision and believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency … We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”

Tobacco harm reduction (THR) products like those that JUUL produces have significantly reduced cigarette use and dependency, resulting in millions of saved lives across the globe. From 2007 to 2015, more than 3 million U.S. adults used THR products to quit smoking cigarettes.

Vaping has been proven to be 95 percent less harmful than traditional smoking. E-cigarettes are a less harmful alternative to traditional cigarettes, which contain more than 6,000 ingredients and, when burned, release more than 7,000 chemicals, including arsenic, formaldehyde, lead, and tar. 

Even though evidence supports that THR products have saved lives, controversy over e-cigarettes is continually fueled by fear-mongering tactics and mistruths about youth vaping. Youth tobacco use is at an all-time low in the U.S. The Centers for Disease Control and Prevention (CDC)  has reported that there were 1.73 million, or 28 percent, fewer youth tobacco users in 2020 (4.47 million) than in 2019 (6.20 million). Youth vaping is already illegal and enforcing the laws on the books by holding retailers accountable for failure to check I.D. would be more effective than banning the products for adults. 

The FDA’s role is to regulate safety and efficacy, not legislate morality. Vaping might be an action that some in society deem unappealing, but that doesn’t mean the products should be banned outright. Tobacco harm reduction products serve a purpose and increase public health by helping adult smokers quit. Several countries have taken an approach to adopt and support the use of tobacco harm reduction products by creating national educational campaigns around the issue. Sweden has smoking rates of 5 percent compared to France at 33 percent, with Great Britain and Denmark at 16 percent. This low rate is primarily attributed to well-researched tobacco harm reduction policies. 

THR products have resulted in fewer deaths and helped adults quit smoking for good. Efforts to limit access to these life-saving devices are ill-chosen and will have long-term adverse effects on public health. Government agencies should work hand-in-hand with private sector companies to continue to bring safe and effective products to market, not act as a barrier to entry.