US Senators Urge FDA to Reform the PMTA Process to Advance Tobacco Harm Reduction Goals

U.S. Senators Joe Manchin, Rand Paul, and Ted Budd (R-NC) jointly sent a letter to the Center for Tobacco Products (CTP) of the U.S. Food and Drug Administration, urging it to reform the Premarket Tobacco Product Application (PMTA) process.

These senators also requested information on CTP's policies and actions to ensure its efficient operation based on science and evidence.

“Smoking is the leading cause of preventable disease and death in the U.S., with nearly 31 million Americans smoking,” they wrote in the letter. “To achieve the FDA's harm reduction goals, there must be an effective authorization process.”

“Since 2009, over 26 million PMTAs for new tobacco products have been submitted in the U.S. Of these applications, fewer than 50 have been approved by the CTP... The availability of scientifically certified and authorized PMTAs or MRTPs could improve health outcomes for smokers currently using higher-risk products.”

The senators stated that to achieve the FDA's harm reduction goals, there must be an effective authorization process, adding that the agency's authorization rate does not align with CTP's policy that recognizes a continuum of risk for tobacco products.

“CTP previously attributed its backlog to staff shortages, but the number of CTP employees has increased from 426 in 2013 to over 1,100 today,” the senators said. “Since 2009, the FDA has also gained the authority to assess and collect user fees from tobacco manufacturers and importers, which have amounted to $712 million annually since 2019.”

“Given these significant resources, it is unreasonable for CTP to be so out of step with the requirements of the Food, Drug, and Cosmetic Act.”