Health Groups Sue FDA to Speed Review of E-Cigarettes
WEDNESDAY, March 28, 2018 -- The U.S. Food and Drug Administration's decision late last year to delay a review of electronic cigarettes and cigars is unlawful and a threat to public health, according to a lawsuit launched by seven medical and public health groups, as well as five individual pediatricians.
According to the groups, the FDA's decision to delay the review means that currently available e-cigarettes and cigars can continue to be sold without information about their health risks or any scientific evidence to support claims of public health benefits.
Those products include candy-flavored products that appeal to youngsters and could lead them into tobacco addiction, the lawsuit says.
The FDA "should remove from the commercial marketplace those tobacco products that pose the greatest health risks, particularly those targeted at children and teenagers," the groups said in the lawsuit.
The lawsuit was filed Tuesday in federal court in Maryland by the American Academy of Pediatrics and its Maryland chapter; the American Cancer Society Cancer Action Network; the American Heart Association; the American Lung Association, Campaign for Tobacco-Free Kids, the Truth Initiative and five individual pediatricians.
The lawsuit also warns that the FDA's decision to delay the review of e-cigarettes and cigars "will hinder the development of the science needed to understand, and to educate the public about, which products actually do promote smoking cessation and how they can be marketed without exposing young people to unnecessary risk."
In August 2016, the FDA gained jurisdiction over e-cigarettes, cigars and other previously unregulated tobacco products. But in August 2017, the agency delayed a requirement that manufacturers of products then on the market had to provide information about each product and that each product had to undergo an FDA review of its impact on public health, including whether it appeals to youngsters.
The new deadlines for filing applications were delayed until August 2021 for cigars and until August 2022 for e-cigarettes. The FDA said the products could remain on the market indefinitely during the review process and did not set a deadline for completing its review.
The long delay in reviewing these products contravenes the 2009 law that gave the FDA oversight of tobacco products, the health groups say. Their lawsuit also says that the FDA broke rules requiring public input on the decision and "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 FDA has so far declined to respond to the lawsuit. But according to the Associated Press, agency Commissioner Dr. Scott Gottlieb in 2017 said that the delay in reviewing e-cigarettes was needed because the FDA and the e-cigarette industry needed more time to prepare.
And speaking last week to the AP, Gottlieb said the FDA would soon take action against "products that are being marketed in kid-appealing ways."
But he also believes e-cigarettes and other alternatives to smoked tobacco may have a role in keeping adult smokers from traditional cigarettes.
"What we don't want to do is snuff out the potential for that innovation before we really have the opportunity to properly evaluate it," Gottlieb told the news service.
The U.S. Centers for Disease Control and Prevention has more on e-cigarettes and youth.
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Posted: March 2018