FDA Offered No ‘Meaningful Justification’ For E-Cigarette Review Delay, Anti-Smoking Groups Say In Lawsuit
The FDA gained authority to regulate e-cigarettes in 2016 after years of pushback from the industry. Manufacturers were supposed to submit their products for review by August, but last year FDA Commissioner Scott Gottlieb said he would delay the deadline until 2022.
The Associated Press:
Lawsuit Challenges FDA Delay Of E-Cigarette Review
Several anti-smoking groups are suing the Food and Drug Administration over a decision by Trump administration officials to delay the review of e-cigarettes. The lawsuit filed Tuesday in federal court argues that the FDA didn't follow proper requirements last year when it decided to push back the deadline for makers of e-cigarettes to submit their products for review. The groups say the delay poses a threat to children's health. (Perrone, 3/27)
The Washington Post:
FDA Sued For Delaying E-Cigarette, Cigar Regulations
The lawsuit is challenging an agency decision last summer to grant lengthy deadline extensions to manufacturers seeking FDA approval for their products. Originally, the companies were required to submit such product-review applications by this August for any item that went on the market after February 2007. The revised timeline changed that to August 2021 for cigars and August 2022 for e-cigarettes. The extensions have been embraced by the e-cigarette industry, which feared that many of its products would be banned under the original schedule. In the suit filed Tuesday, health groups argue that the delay allows flavored tobacco products that target children and teenagers to remain on the market. (McGinley, 3/27)
The Hill:
Public Health Groups Sue FDA
The Campaign for Tobacco-Free Kids and other groups behind the lawsuit argue candy flavored cigars and e-cigarettes appeal to children, who could grow addicted while the products are sold and before the reviews are completed. “As a result of the guidance, consumers will continue to be exposed for many years to thousands of tobacco products containing lethal and addictive components that have not met the statutory requirements,” the groups said in their 45-page complaint, filed in the U.S. District Court for the District of Maryland. (Wheeler, 3/27)
