Washington, D.C.— December 14, 2021 – Late yesterday, the U.S. Food and Drug Administration (FDA) opposed public health groups’ request that the agency provide regular status reports to a U.S. District Judge and estimate the dates it expects to complete its review of the Premarket Tobacco Product Applications (PMTAs) for products that rank among the top 10 brands in market share. The opposition comes more than three months after the FDA failed to comply with a court-ordered deadline to rule on all e-cigarette and other tobacco product manufacturers’ applications to keep their harmful products on the market.
The September 9th deadline was set as the result of a 2018 lawsuit filed by the American Cancer Society Cancer Action Network (ACS CAN) and numerous other public health groups challenging the FDA’s decision to delay reviewing products based on if they are “appropriate for the protection of the public health” until August of 2022.
A statement from Lisa Lacasse, president of ACS CAN follows:
“The FDA’s refusal to commit to progress reports and an estimated timeline for the most commonly-used products is extremely disappointing and will allow the industry to further endanger public health and hook more kids on their highly addictive products.
“There are overwhelming data to demonstrate the negative impact these kinds of products have had on public health and particularly the role of flavored products in the youth tobacco epidemic. If we are to reduce suffering and death from cancer, we must prevent youth tobacco initiation and FDA’s premarket review process is important in that work.
“FDA has issued or denied marketing orders only for products with minimal market share, withholding decisions on any of the e-cigarette products sold in significant quantities, including the products most responsible for the youth tobacco epidemic. The reports are in the public interest because they would allow the court to assess, on a continuing basis, the extent to which FDA is prolonging the unlawful regulatory holiday that contributed to the ongoing epidemic.”