Manchin, Paul, Budd Call on FDA to Revamp Evaluation Process for Tobacco Harm-Reduction

This week, U.S. Senator Joe Manchin joined Senators Rand Paul and Ted Budd in urging the U.S. Food and Drug Administration Center for Tobacco Products (CTP) to reform its application review process for electronic nicotine delivery systems (ENDs). Called into question was the Premarket Tobacco Product Application (PMTA) process.  

 

The Senators also requested information about CTP’s policies and actions that would ensure they are acting efficiently and making decisions based on science and evidence. 

 

“According to the Centers for Disease Control and Prevention (CDC), cigarette smoking is the leading cause of preventable disease and death in the United States, where nearly 31 million Americans smoke cigarettes. Less than eight percent of smokers will successfully quit smoking each year, while thousands will start smoking every day. Combustible cigarette smoking is on the decline due in part to the availability of harm reduction alternatives. Congress recognized the importance of harm reduction when it passed the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009 (the "Act"), which charged the FDA with establishing one of the most comprehensive approaches to tobacco harm reduction in the world. The Act requires the CTP to make application determinations within 180 days, yet the agency routinely fails to meet this requirement.” 

 

“For the FDA to meet its harm reduction goals, it must have a functioning authorization process. Since 2009, more than 26 million premarket tobacco product applications (PMTAs) have been submitted for new tobacco products in the U.S. Of those 26 million applications, the CTP has authorized fewer than 50. Remarkably, it has also authorized a total of only 16 Modified Risk Tobacco Products (MRTPs) for only four unique products and their accessories. This miniscule authorization rate is not in keeping with the CTP policy acknowledging that tobacco products fall on a continuum of risk. The availability of scientifically substantiated, authorized-PMT As or MRTPs could potentially improve health outcomes for smokers currently using riskier products.” 

 

The full letter can be found here. 

 

 

American Vapor Manufacturers (AVM) broke the story on X (Twitter) 

 

 

 

We eagerly anticipate the FDA's response to the crucial inquiries presented in this impactful letter. 

 

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