By AMERICAN HEART ASSOCIATION NEWS
Several public health groups, medical organizations and pediatricians are suing the Food and Drug Administration over the federal agency’s decision to delay product reviews for e-cigarettes and cigars for several years.
The lawsuit, filed Tuesday in the U.S. District Court for the District of Maryland, challenges the FDA’s decision to allow these products to remain on the market for years without being reviewed by the agency – including those with flavors such as gummy bear, cotton candy and chocolate that appeal to children.
Tobacco use is the No. 1 preventable cause of death in the United States, killing more than 480,000 Americans and costing about $170 billion in health care expenses each year.
The health groups’ lawsuit contends that the FDA’s lengthy delay of product review deadlines exceeds the agency’s authority under the Family Smoking Prevention and Tobacco Control Act (the 2009 law that established FDA oversight of tobacco products).
It also contends that the FDA’s decision violates the Administrative Procedure Act because the FDA did not give the public an opportunity to comment on the change and did not articulate an adequate factual basis for this radical change from the deadlines the FDA itself established in the deeming rule.
The suit was filed by the American Heart Association, American Academy of Pediatrics and its Maryland chapter, American Cancer Society Cancer Action Network, American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative and five pediatricians.
The products at the center of the suit have become increasingly popular among youths.
A report this year by the National Academies of Sciences, Engineering and Medicine concluded, “There is substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults.”
A 2016 Surgeon General’s report found a substantial jump in the use of e-cigarettes among U.S. high school students, from 1.5 percent in 2011 to 11.3 percent by 2016.
Researchers theorized that teens find e-cigarettes more appealing because of the wide variety of flavors.
One example is the recent boom in popularity of a product called Juul, the best-selling e-cigarette brand that is reported to be widely used by teens. Sold in variety of flavors – including crème brûlée and fruit medley – the manufacturer claims each Juul cartridge contains as much nicotine as a pack of cigarettes.
The FDA “offered no meaningful justification for ripping a hole in the statutory framework by exempting, for more than half a decade, newly deemed products from premarket review – review FDA previously described as ‘central’ to the regulatory scheme Congress enacted for tobacco products,” the lawsuit says.
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