American Heart Association (AHA)
April 24, 2018
The Food and Drug Administration (FDA) today has taken important initial steps to address the dramatic rise in youth use of Juul e-cigarettes. We commend the FDA and Commissioner Scott Gottlieb for recognizing the seriousness of the problem and taking enforcement action to prevent Juul sales to youth. However, the FDA must do more by taking off the market Juul flavors like mango and cool cucumber that clearly appeal to children and adolescents, preventing the introduction of look-alike products and subjecting e-cigarettes to FDA review of their public health impact, as required by law.
While a positive step forward, today’s action does not address one of the most important actions the FDA can take to protect youth, which is to enforce existing law and the FDA’s existing rules prohibiting the introduction of new or changed tobacco products – including e-cigarettes – without prior FDA review and authorization.
Without such FDA review, mango and cool cucumber-flavored Juul products should never have been allowed for sale and their current sale is illegal. The same is true for other newly-introduced tobacco products, possibly including the current version of two products mentioned by Commssioner Gottlieb, myblu and KandyPens. The FDA can and should take immediate action to address these issues and, moving forward, the FDA should utilize this authority to prevent the introduction of child-friendly tobacco products in the first place, rather than taking action after they become popular with young people.
The FDA should be commended for taking these important steps today, but the problem can’t be solved if the FDA doesn’t enforce its own rules requiring prior review of new or changed products. The rise in youth use of Juul is due in part to the FDA’s failure and delay in enforcing this critical regulation.
These problems will also continue unless FDA reverses its decision that allows e-cigarettes that were on the market as of August 8, 2016, to stay on the market until at least 2022 without undergoing review by the FDA. Leading public health and medical organizations filed suit last month challenging the FDA’s delay, arguing it is unlawful and harms public health by leaving on the market products that appeal to youth. These organizations also wrote to the FDA last week, urging the agency to take strong and immediate action to address the dramatic rise in teen use of Juul e-cigarettes.