Citing a “clear public health emergency,” U.S. District Judge Paul Grimm has once again shifted the Food and Drug Administration review date for manufactured e-cigarette products. This should make the anti-tobacco and public-health groups that brought upon a court case stating that the FDA had delayed the earlier application deadline somewhat happy. The groups, according to Bloomberg, “argued that the agency had abdicated its duty to regulate the products.”
The date has changed a lot since the administrative changes in 2016, but as of now, vaping companies must submit their applications by May 2020. Products will be allowed to stay on the marketed for one year while the FDA wades through the safety and public health paperwork. This is a definite shift from the August 2022 application deadline. The groups that initially filed the suit asked for a 4-month process, but the judge said that 10 months was the quickest he could sign off on. Matthew Myers, president of the Campaign for Tobacco-Free Kids, one of the groups who filed the suit, said that 10 months is “a dramatic improvement.”
“Given the uncertainty in the efficacy of e-cigarettes as smoking cessation devices, the overstated effects that a shorter deadline may have on manufacturers, the industry’s recalcitrance, the continued availability of e-cigarettes and their acknowledged appeal to youth, and the clear public health emergency, I find that a deadline is necessary,” Grimm wrote in his order as reported on by Bloomberg.
Controversial manufacturers JUUL have shown support of the application process and have previously said they are preparing for regulations.
JUUL spokesperson Lindsay Andrews told Bloomberg, “We’re confident in the content and quality of the materials we will submit with our application.”
Ned Sharpless, the FDA’s acting commissioner since Scott Gottlieb’s departure in April, told Bloomberg that the FDA “stands ready to accelerate review of these products and will continue its vigorous enforcement and public education efforts to protect kids from e-cigarettes.”
For companies scrambling to make the new deadline, check out our blog on PMTA Guidelines, which were released last month.