Seven anti-smoking groups and several pediatricians have sued the U.S. Food and Drug Administration over a decision to delay the review of electronic cigarettes and cigars in the market.
Extended Deadline
The lawsuit, which was filed on Tuesday in federal court, challenges FDA's decision last year that granted lengthy deadline extensions to manufacturers who were seeking the health regulator's approval for their products.
Companies were originally required to submit these product-review applications by August this year for items that became available on the market after February 2007. FDA's decision extended this deadline to August 2022 for e-cigarettes, and August 2021 for cigars.
"Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications," the FDA said when it announced the extended deadline in July last year.
The extensions were a relief for the e-cigarette industry as manufacturers feared that many of their products would not be green-lighted under the original schedule.
Downsides Of Delaying Reviews
The lawsuit, however, said that the delay allowed flavored tobacco products that target young users to remain on the market.
The groups contend that delaying product reviews leaves children and teens more vulnerable to e-cigarette and cigar products that target them, which could lead to a lifetime of addiction to tobacco products.
A 2016 study has shown that frequent vaping in teens may lead to heavy cigarette smoking later in life. Other studies have likewise shown the dangers associated with these products. Researchers have found that use of e-cigarettes elevates cancer risk and e-cigarette flavoring can have toxic effects on human lung cells.
"Our concern is that we can't leave our kids vulnerable while FDA waits for e-cig manufacturers to apply," said Matthew Myers, president of Campaign for Tobacco-Free Kids, one of the groups that filed the lawsuit against the FDA.
The groups said that they strongly support FDA's new efforts in reducing the amount of nicotine present in cigarettes to less dangerous levels. However, they believe that the decision to exempt e-cigarettes and cigars from agency reviews for years to come harms public health and is unlawful.
The lawsuit contends that the decision deprives the FDA and the public of important information about the health impact of the products that are already sold in the market, as well as relieves the manufacturers of the burden to provide scientific evidence that their products can benefit public health.
