District Judge Rules FDA Must Provide Status Reports on Premarket Tobacco Product Applications

April 15, 2022

Washington, D.C.— Today United States District Judge Paul W. Grimm ruled in American Academy of Pediatrics et al v FDA that beginning on April 29 and every 90 days thereafter, the Food and Drug Administration (FDA) must provide regular status reports to the court and the public on the percentage of premarket tobacco product applications (PMTA) the FDA expects to have acted on by June 2022, and beyond. The covered applications must include JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin, or Puff Bar, or reach 2% of total retail sales as reported by Nielsen.

Despite a deadline of Sept. 9, 2021 to review all PMTA applications, FDA has issued or denied marketing orders only for products with minimal market share to date, withholding decisions on any of the e-cigarette products sold in significant quantities, including the products most responsible for the youth tobacco epidemic. As a result, ACS CAN and its partners requested that the court require status reports from FDA last fall.  The agency opposed this request in December. Today, the court sided with the public health groups.  

The following is a statement from the American Cancer Society Cancer Action Network (ACS CAN).

“FDA’s years-long delay in oversight of JUUL and other e-cigarettes significantly contributed to today’s youth tobacco epidemic. Their continued failure to act on PMTAs for products with the largest market share allows this industry to further endanger public health and addict more kids. To reduce suffering and death from cancer, we must prevent young people from becoming addicted to tobacco products.

“We are encouraged by Judge Grimm’s ruling to require FDA provide regular updates on their progress assessing applications. The regulatory holiday e-cigarette manufacturers have been given must end.

“The public deserves to know when FDA will take the court-ordered action to regulate these products and FDA must be held accountable to the timeline. In the meantime, ACS CAN urges federal, state and local officials to continue their essential work regulating these highly addictive and harmful products.”

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Emily Burr
Director, Media Advocacy
Washington, D.C.