Bowling Green Today

U.S. Senators Rand Paul, Joe Manchin, and Ted Budd have written 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 tobacco products. The Senators are also seeking information about CTP's policies and actions to ensure that the agency is acting efficiently and based on science and evidence.

In their letter, the Senators highlight the importance of harm reduction in addressing the public health crisis caused by cigarette smoking. They note that cigarette smoking is the leading cause of preventable disease and death in the United States, with nearly 31 million Americans still smoking. The Senators highlight that the availability of harm reduction alternatives has contributed to the decline in combustible cigarette smoking.

The Senators point out that the FDA has been tasked with establishing one of the most comprehensive approaches to tobacco harm reduction in the world through the Family Smoking Prevention and Tobacco Control Act of 2009. However, they express concern that the FDA's authorization process has been slow and inefficient. They note that out of more than 26 million premarket tobacco product applications (PMTAs) submitted since 2009, the CTP has authorized fewer than 50. Similarly, the CTP has authorized only 16 Modified Risk Tobacco Products (MRTPs) for four unique products and their accessories.

The Senators argue that this low authorization rate is not in line with the recognition that tobacco products fall on a continuum of risk. They emphasize that the availability of scientifically substantiated, authorized PMTAs or MRTPs could potentially improve health outcomes for smokers using riskier products.

The Senators raise concerns about the backlog in the CTP's review process. They note that despite staffing increases and the collection of user fees from tobacco manufacturers and importers, the CTP has failed to meet the Act's requirement of making application determinations within 180 days.

To address these concerns, the Senators reference a December 2022 review by the independent Reagan Udall Foundation (RUF), which recommended that the CTP develop a more clear and predictable framework for PMTA and MRTP application submission and reviews. In light of these recommendations, the Senators pose several questions to the FDA, including whether the agency prioritizes the review of PMTAs or MRTPAs and if it supports a supplemental PMTA process.

The Senators also inquire about the FDA's efforts to raise public awareness of the difference in risk between product categories and to encourage smokers to switch to less harmful products. They ask for specific scientific criteria that the CTP considers in its assessment of whether a PMTA product is appropriate for the protection of public health.

In addition, the Senators inquire about the CTP's criteria for determining whether to provide applicants an opportunity to address application deficiencies before issuing a Refuse to Accept (RTA) decision. They also reference a recent article calling on the FDA to set a definition for premium cigars and ask whether the FDA agrees with this approach.

The Senators request a response from the FDA within 30 days of the date of their letter.

This call for reform from Senators Paul, Manchin, and Budd highlights the need for the FDA to streamline its application review process for harm-reduced tobacco products. By addressing the backlog and prioritizing the review of PMTAs and MRTPAs, the FDA can improve access to safer alternatives for smokers and potentially reduce the harm caused by cigarette smoking.

Click this link to access more information: https://www.paul.senate.gov/senators-paul-manchin-budd-send-letter-to-fda-urging-ctp-reform-for-harm-reduced-products/