By Laura J. Simon, Esquire

The FDA’s Inexcusable Failure to Determine Whether Juul “Benefits Public Health”

Last week, the FDA faced a court-imposed deadline on marketing applications from Juul and hundreds of other e-cigarette/vaping companies.  Many rejections were issued, but the decision on the biggest and most powerful company, Juul, was delayed again.  Meanwhile, Juul has been selling its products since 2015, even though the standard for it to be sold in the United States is that the product benefits public health.

The United States Food and Drug Administration operates under the United States Department of Health and Human Services, and its purpose is to ensure the safety of many consumer products.  The categories of products are listed on fda.gov and include:  “food, drugs, medical devices, radiation-emitting products, vaccines, blood and biologics, animal and veterinary, cosmetics, and tobacco products.”  The FDA has regulated cigarettes since 2009.  As of 2020, the FDA employed 18,062 individuals, with the “Family Smoking Prevention and Tobacco Control Act” having 992 employees.  (fda.gov).

For many years prior, cigarette and tobacco use had been greatly reduced due to regulations, education, and the unpopular and unhealthy stigma attached to smoking.  The vaping and e-cigarette industry grew in the United States in 2006, with the supposed goal of cigarette smoking cessation.  No long-term studies proved these claims. Many countries banned e-cigarettes due to their potentially dangerous ingredients.  Intense debate occurred in the United States, with minimal action by the FDA.  (See Historical Timeline of Vaping and Electronic Cigarettes, www.casaa.org).

Starting in 2015, Juul aggressively and systematically marketed their sleek e-cigarette to teenagers through social media advertisements, social influencers, promotions, and online sales.  Flavors included creme brûlée, mango, fruit medley and many more.  Sales of knock-off Juul products also boomed, with no regulations whatsoever.  High schools across America were faced with huge numbers of teens newly addicted to nicotine, as the products contain levels much higher than cigarettes.

In September 2018, the FDA called teen vaping an epidemic and ordered manufacturers to submit plans to decrease youth use.  Public outrage and a slew of lawsuits filed by states, municipalities, schools, and individuals resulted in some flavors, clearly marketed to teens, to be removed from the market.  Juul decided to discontinue selling all flavors except tobacco, mint, and menthol.  However, many of the other flavors can still be found on online vape stores to this day.

While the FDA is taking many years to “study” the health effects of Juul, many people continue to use the product.  It seems backwards; shouldn’t the product be tested and approved before it is allowed on the market?  While a multi-billion-dollar industry has been allowed to survive, our citizens’ health has been sacrificed by the FDA.

If you have been injured by Juul or other e-cigarettes/vaping, please contact Laura Simon at
lsimon@dalton.law