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Federal Judge Orders FDA Regulation of E-Cigarettes

A federal judge sided with health advocacy groups in ruling that the Food and Drug Administration must stop electronic cigarette companies from selling their products until they win approval from the agency.

GREENBELT, Md. (CN) - A federal judge sided with health advocacy groups in ruling that the Food and Drug Administration must stop electronic cigarette companies from selling their products until they win approval from the agency.

In a lawsuit filed in March of last year, the American Academy of Pediatrics, American Heart Association, American Lung Association and other groups and physicians claimed the FDA, under the Trump administration, shirked federal procedure in issuing new guidance for the vaping tobacco products.

The agency violated sections of the Tobacco Control Act requiring federal approval for nicotine-based products before they can be sold by allowing e-cigarettes to be brought to market without preapproval, according to the complaint filed by attorneys with the Washington, D.C.-based Wilmer Cutler firm.

“FDA’s ‘guidance’ is manifestly unlawful in multiple respects and must be vacated,” the lawsuit states. “The guidance exceeds the agency’s statutory authority and is not in accordance with law because it is an express and deliberate abdication of FDA’s responsibilities.”

While the FDA argued its treatment of e-cigs was protected as agency discretion, a federal judge in Maryland disagreed in a ruling released Wednesday.

“The undisputed evidence establishes that defendants were required to, but did not, follow the [Administrative Procedure Act’s] notice and comment requirements issuing the August 2017 guidance, and therefore defendants violated the APA by issuing it,” U.S. District Judge Paul W. Grimm wrote in the often colorful 54-page opinion, which included a picture of a child's juice box in a footnote discussing e-cig flavors that could be marketed to those under the age of 18.

“Manufacturers long have been on notice that they will have to file premarket approval applications, substantial equivalence reports, and exemption requests,” Grimm wrote. “If they have chosen to delay their preparations to do so, then any hardship occasioned by their now having to comply is of their own making.”

The health advocacy groups suing the FDA applauded the judge’s decision in a joint statement released Thursday morning.

“It is now the FDA's responsibility to take immediate action to protect our kids and require manufacturers to apply to the FDA if they want to keep their products on the market, including products like Juul that have fueled the youth e-cigarette epidemic,” the statement reads.  

In a statement to Courthouse News, FDA spokesman Michael Felberbaum said the agency is still reviewing Grimm’s decision but “will continue to tackle the troubling epidemic of e-cigarette use among kids.”

E-cigarettes, which use water and chemicals to produce a flavored and nicotine-filled vapor, were once hailed as an alternative to traditional smoking but have since been plagued by accusations of marketing to children and questionable production methods. There is also little research on the long-term effects of the cigarette alternative.

In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act which aimed to require preauthorization of e-cig products before they went to market, but legal challenges from tobacco companies have slowed implementation of the requirements.

President Donald Trump’s former FDA Commissioner Scott Gottlieb, who stepped down last month, said the agency would not require e-cigarette companies to file for review of their products until 2022. That deadline was later moved up to 2021.

While Judge Grimm seemed open to the FDA’s argument that implementation of the new rules would be forthcoming, he took a shot at the agency in his ruling saying “its notion of ‘as quickly as possible’ must be taken with a grain of salt.”

Also on Wednesday, North Carolina’s attorney general sued leading e-cigarette maker Juul, claiming its marketing tactics are contributing to an epidemic among young people. The lawsuit asks a judge to limit the flavors Juul can sell.

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