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ASAM Urges FDA to Release Information Regarding Premarket Review Process for Tobacco Products

April 23, 2020


On April 23, ASAM, the Campaign for Tobacco-Free Kids, and 51 other organizations sent a letter to Dr. Stephen Hahn, Commissioner of Food and Drugs at the U.S. Food and Drug Administration (FDA), urging FDA to disclose the information necessary for the public to know the products for which premarket applications have been filed and are undergoing the premarket review mandated by the Family Smoking Prevention and Tobacco Control Act. The letter also asked FDA to identify those products still being marketed in violation of that statute.


The letter stresses that due to the youth e-cigarette epidemic, and concerns that smoking and vaping may increase the risk of severe complications from COVID-19,1 it is vital that new tobacco products be subject to statutorily-required public health review by the FDA and that products for which timely and complete applications are not filed be removed from the marketplace as quickly as possible. It furthermore notes that disclosure of information pertaining to FDA’s premarket review process is necessary to allow the public to determine the extent of industry compliance with the court-ordered September 9 deadline for filing premarket applications, as well as to monitor the FDA’s enforcement of the deadline going forward.


Read the letter here.