The American Thoracic Society led 10 medical professional organizations in filing an amicus brief last week regarding the FDA’s failure to apply premarket review to new tobacco products. The brief was submitted in support of the American Academy of Pediatrics and its co-plaintiffs and outlines the compelling data indicating that the FDA’s failure to act harms children.
At the crux of the suit brought by the American Academy of Pediatrics against the FDA is the agency’s failure to apply its pre-market review authority to tobacco products that were introduced to the US market after February 2007.
It is the view of the ATS that the Family Smoking Prevention and Tobacco Control Act gave the FDA the authority and obligation to conduct pre-market review of all tobacco products that were introduced to the US market after February 2007. E-cigarettes and a new generation of candy-flavored tobacco products that are heavily marketed to children have not undergone FDA pre-market review.
In 2016, the FDA issued a schedule for conducting pre-market review of cigars and e-cigarettes. However, the Trump Administration announced substantial delays (as long as four years for some products) in the schedule originally announced by the FDA.
The amicus brief filed by ATS and other organizations aims to share with the court the available evidence illustrating that the FDA’s inaction is currently causing harm and will continue to cause harm. Without pre-market review requirements, big tobacco will continue to have the luxury of time to amplify their marketing to children, who are the key target for candy-flavored tobacco products. With exposure to these products come the potential for addiction.