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 are also requesting information about CTP's policies and actions to ensure that it is acting efficiently and based on science and evidence.

In the letter, the Senators highlight the importance of harm reduction in addressing the public health issue of cigarette smoking, which is the leading cause of preventable disease and death in the United States. They mention that the availability of harm reduction alternatives has contributed to the decline in combustible cigarette smoking. They also note that Congress recognized the significance of harm reduction when it passed the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009, which tasked the FDA with establishing a comprehensive approach to tobacco harm reduction.

However, the Senators express concern that the CTP is not meeting its obligations under the Act. They point out that since 2009, over 26 million premarket tobacco product applications (PMTAs) have been submitted for new tobacco products in the U.S., but the CTP has authorized fewer than 50. They also note that 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 does not align with the CTP's acknowledgment that tobacco products fall on a continuum of risk.

The Senators call attention to the fact that the CTP has attributed its backlog to staffing shortages, despite the significant increase in its staff over the past decade. They also mention that the FDA has the authority to collect user fees from tobacco manufacturers and importers, which amount to $712 million annually since 2019. Given these resources, the Senators question why the CTP is failing to meet the requirements of the Act.

To support their concerns, the Senators reference a review conducted by the independent Reagan Udall Foundation (RUF) in December 2022. The RUF recommended that the CTP develop a clearer and more predictable framework for high-quality 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 its review of PMTAs or MRTPAs and whether it supports a supplemental PMTA process.

The Senators also inquire about the CTP's efforts to raise public awareness of the difference in risk between tobacco product categories and to encourage smokers to switch to less harmful products. They question the specific scientific criteria that the CTP considers in assessing whether a PMTA product is appropriate for the protection of public health and whether the CTP applies any criteria to determine whether to provide applicants an opportunity to address application deficiencies before issuing a Refuse to Accept (RTA) decision.

Lastly, the Senators mention an article from the Society for Research on Nicotine and Tobacco that called on the FDA to establish a definition for premium cigars. They inquire whether the FDA agrees with this approach and with creating a separate category for premium cigars to promote risk-appropriate research and regulation.

The Senators request a response from the FDA within 30 days of the date of the letter. They emphasize the importance of these questions and look forward to the agency's responses.

This letter from Senators Paul, Manchin, and Budd highlights the need for the FDA Center for Tobacco Products to reform its application review process for harm-reduced products. The Senators are calling for more efficiency and a scientific evidence-based approach to ensure that harm reduction alternatives are accessible to smokers. They raise concerns about the low authorization rate of PMTAs and MRTPs and question the CTP's prioritization process. The Senators also inquire about the CTP's efforts to raise public awareness and assess the scientific criteria used in evaluating products. Their letter emphasizes the importance of addressing these issues to promote public health and reduce the harms associated with combustible cigarette smoking.