FDA Puts Forth 10-Month Deadline For E-Cig Applications

Law360
14 Jun, 2019 ,

The U.S. FDA proposed a 10-month deadline for e-cigarette companies to submit applications to keep their products on the market in response to a Maryland federal judge's ruling that the agency overstepped its authority by allowing e-cigarettes to stay on the market until 2022. The FDA's proposal comes a month after U.S. District Judge Paul W. Grimm ruled that the agency acted illegally in 2017 when the agency extended deadlines to submit marketing applications, saying the decision defeated the purpose of the Tobacco Control Act by allowing unapproved tobacco products to be made and sold, exacerbating the public health issue of youth vaping.

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The U.S. Food and Drug Administration on Wednesday proposed a 10-month deadline for e-cigarette companies to submit applications to keep their products on the market in response to a Maryland federal judge's ruling that the agency overstepped its authority by allowing e-cigarettes to stay on the market until 2022.

The FDA's proposal comes a month after U.S. District Judge Paul W. Grimm ruled that the agency acted illegally in 2017 when the agency extended deadlines to submit marketing applications, saying the decision defeated the purpose of the Tobacco Control Act by allowing unapproved tobacco products to be made and sold, exacerbating the public health issue of youth vaping.

The public health advocates who brought the suit want a deadline of 120 days after the ruling for companies to submit applications, according to the agency's brief, but the agency says that such a short timeline would create a massive administrative headache that would be ultimately counterproductive.

Those applications are complex, and a 120-day deadline would likely lead to a mass market exit of e-cigarettes, "creating a genuine risk that former smokers addicted to nicotine could migrate back to conventional cigarettes," the FDA said.

Under the proposal, the FDA would have a year to review the applications, according to the brief.

So far, the FDA said that it's received 401 premarket tobacco applications, but almost all of them failed to meet basic requirements.

The public health groups, including the Campaign For Tobacco-Free Kids, filed suit in 2018, alleging that the FDA's decision to extend the marketing application deadlines threatened public health by leaving minors more vulnerable to kid-friendly e-cigarette flavors.

"E-cigarette manufacturers have no one but themselves to blame if they are not ready to submit the required applications," Matthew L. Myers, president of the Campaign For Tobacco-Free Kids, said in a statement. "It is time for the FDA to stop making excuses and to meet its legal obligation to subject e-cigarettes to public health review."

The FDA also said that it was committed to finalizing draft guidance issued in March that lays out its enforcement priorities for e-cigarettes, particularly with respect to e-cigarettes targeted to minors.

"The approach outlined in the court filing reflects the FDA's continued commitment to tackling the troubling epidemic of e-cigarette use among kids by maintaining our focus on enforcement actions and policies aimed at ensuring e-cigarettes aren't being marketed to, sold to or used by kids," an agency spokeswoman told Law360 on Thursday. "We will continue to focus our efforts against manufacturers and retailers who market or sell e-cigarettes to minors while expanding our paid advertising program to educate youth about the dangers of these products."

The public safety groups are represented by Dennis A. Henigan and Mark E. Greenwald of the Campaign for Tobacco-Free Kids, Javier M. Guzman and Jeffrey B. Dubner of the Democracy Forward Foundation and Eve L. Hill of Brown Goldstein & Levy.

The FDA is represented by Jody Hunt, James M. Burnham and Eric B. Beckenhauer of the U.S. Department of Justice's Civil Division, general counsel for the U.S. Department of Health and Human Services, Robert P. Charrow, and Stacy Cline Amin, Wendy S. Vicente and Samantha Hong of the FDA chief counsel's office.

The case is American Academy of Pediatrics et al. v. Food and Drug Administration et al., case number 18-cv-00883, in the U.S. District Court for the District of Maryland.