Bowling Green Today

Washington, D.C. - U.S. Senators Rand Paul, Joe Manchin, and Ted Budd have sent a letter to Dr. Robert Califf, Commissioner of Food and Drugs at the U.S. Food and Drug Administration (FDA), urging the FDA Center for Tobacco Products (CTP) to reform its application review process for harm-reduced products. The senators also requested information about CTP's policies and actions to ensure it is acting efficiently and based on science and evidence.

Cigarette smoking is the leading cause of preventable disease and death in the United States, with nearly 31 million Americans still smoking. The availability of harm reduction alternatives has contributed to the decline in combustible cigarette smoking. In 2009, Congress passed the bipartisan Family Smoking Prevention and Tobacco Control Act, which tasked the FDA with establishing a comprehensive approach to tobacco harm reduction.

However, the CTP has been struggling to meet the requirements of the Act. Since 2009, over 26 million premarket tobacco product applications (PMTAs) have been submitted, but the CTP has authorized fewer than 50. The authorization rate for Modified Risk Tobacco Products (MRTPs) is even lower, with only 16 authorized for four unique products and their accessories. This low authorization rate is not in line with the CTP's acknowledgment that tobacco products fall on a continuum of risk.

The CTP has previously blamed staffing shortages for its backlog, but its staff has more than doubled over the past decade. Additionally, the FDA has been collecting significant user fees from tobacco manufacturers and importers since 2009. With these resources, there is no reason for the CTP to be so out of step with the Act's requirements.

In a review conducted by the independent Reagan Udall Foundation, it was found that the CTP has been struggling as a regulator and needs to develop a clearer and more predictable framework for reviewing PMTAs and MRTP applications. In light of these findings, the senators have requested information regarding the prioritization of PMTAs and MRTPAs, the consideration of accelerated review programs, the support for a supplemental PMTA process, efforts to raise public awareness of the difference in risk between tobacco product categories, and the criteria for determining application deficiencies.

The senators have given the FDA 30 days to respond to their letter and are eagerly awaiting the agency's responses to these important questions.

To find out more, go to this link: https://www.paul.senate.gov/senators-paul-manchin-budd-send-letter-to-fda-urging-ctp-reform-for-harm-reduced-products/