Three U.S. Senators Ask FDA To Reform E-cigarette PMTA Process
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Three U.S. senators ask FDA to reform e-cigarette PMTA process
On December 13, three U.S. senators from both parties wrote to U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, urging him to reform the FDA's tobacco product application process and asking him to explain and clarify the FDA's regulation of nicotine products. Methods.
The letter was signed by Republican Senators Ted Budd (North Carolina) and Rand Paul (Kentucky), and Democratic Senator Joe Manchin (West Virginia).
The Tobacco Control Act requires the FDA's Center for Tobacco Products to review and decide on premarket tobacco product applications (PMTA) and modified risk tobacco product applications (MRTP) within 180 days, and the senators noted that the FDA has demonstrated that the agency cannot meet review deadlines , only a few non-combustible nicotine products were authorized during this period.
The senators also wrote in the letter that since 2009, more than 26 million new tobacco product premarket applications (PMTA) have been submitted in the United States, and of these 26 million applications, the Center for Tobacco Products (CTP) has approved less than 26 million. 50 servings. Notably, it has also approved a total of 16 Modified Risk Tobacco Products (MRTPs) for only four unique products and their accessories.
This extremely low authorization rate is inconsistent with Center for Tobacco Products policy, which recognizes the continuum of risks associated with tobacco products. The availability of scientifically substantiated, authorized PMTA or MRTP may improve health outcomes for smokers who currently use riskier products.
Since the FDA authorized the regulation of e-cigarette products in 2016, the agency has approved only seven atomization-based e-cigarette devices for sale in the United States. In light of this, the senators cited a December 2022 Reagan-Udall Foundation report that concluded that the Center for Tobacco Products (CTP) has largely failed as a regulatory agency and advised the FDA Commissioner Kalif asked a series of questions:
Is the agency prioritizing review of PMTA or MRTPA? If so, what criteria does CTP apply in this prioritization process?
If FDA does not prioritize review of PMTA or MRTPA, do you agree that a priority strategy should be developed?
Other centers also have FDA programs that expedite the review of certain products that may benefit the public health (such as breakthrough designation). Has CTP considered whether and how to incorporate this concept into its tobacco product review program?
Does CTP support the supplemental PMTA process? If so, what steps is the agency taking to: (1) encourage use of the supplemental PMTA pathway and (2) take steps to expedite decision-making on supplemental applications?
Given the FDA's recognition of the continuum of risks associated with nicotine-containing products, what steps is the agency taking to increase public awareness of risk differences between product categories and encourage smokers to switch to less harmful products?
The CTP's assessment of whether a PMTA product is "suitable to protect public health" includes an assessment of the extent or likelihood that the product will promote complete cessation or significantly reduce the use of combustible cigarettes in adult smokers. What specific scientific criteria did the CTP consider in this evaluation, and how was each criterion weighed or balanced in the final decision?
Does the CTP apply any criteria to determine whether the applicant will be provided an opportunity to address application deficiencies before issuing a Refuse to Accept (RTA) decision? If so, what are these criteria?
A recent article from the Nicotine and Tobacco Research Association called on the FDA to develop a definition for premium cigars. Does the FDA agree with this approach and agree to establish a separate category for premium cigars to promote risk-appropriate research and regulation?
The senators gave Kalif 30 days to respond to their questions.
