On Sep. 9, the U.S. Food and Drug Administration (FDA) issued a warning letter to JUUL Labs Inc. for “marketing unauthorized modified risk tobacco products by engaging in labeling, advertising, and/or other activities directed to consumers, including a presentation given to youth at school.” In a separate letter sent to JUUL, the FDA expressed concern over issues raised during a July 24 Congressional hearing on JUUL’s marketing practices and requested documents regarding JUUL’s marketing campaigns and tactics.
These letters are the most recent development in the FDA’s ongoing investigation and stricter oversight of the e-cigarette company: “[r]egardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.” In other words, JUUL has been marketing its e-cigarette products as safer alternatives to other tobacco products without the appropriate FDA order needed to do so.
JUUL’s marketing, which frequently targets youth and young adults, has made or implied the following claims:
- JUUL presents a lower risk of tobacco-related disease and/or are less dangerous than other tobacco products.
- JUUL products contain a reduced level of a substance or substances.
- JUUL products are free of a substance or substances.
Several problematic statements identified in the warning letter came from the July Congressional hearing on JUUL, during which it came to light that a JUUL representative had made several misleading claims in a school presentation. These false claims included that JUUL “was much safer than cigarettes”, the “FDA would approve it any day”, it was “totally safe”, and that JUUL was “a safer alternative than smoking cigarettes” for nicotine-addicted youth. None of these claims have ever been approved by the FDA.
The letters come amid widespread national concern about the health dangers associated with vaping, as federal health officials are in the process of reviewing 450 possible cases and six deaths known to be linked to vaping-related lung disease in 33 states. On Sep. 4, the Ohio Department of Health confirmed that three reports of severe pulmonary illness after using e-cigarette products are likely linked to vaping, and that an additional 11 reports are under investigation in the state.
As of now, health officials have not yet pinpointed the specific cause of illness in e-cigarette users. On Sep. 6, the FDA released a statement telling consumers to avoid THC-containing vaping products as the health investigation is ongoing. On the same day, the Centers for Disease Control and Prevention (CDC) urged consumers to avoid nicotine-based e-cigarette products. At a minimum, the safest course of action is to avoid vaping altogether until more is known.
If you or a loved one became addicted to nicotine or developed lung disease as a result of using JUUL’s e-cigarette products, contact the attorneys at Murray & Murray Co., L.P.A. in Ohio today to discuss your legal options today.