Senators Ask Califf to Explain FDA’s PMTA Review Process

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A bipartisan trio of U.S. senators has sent a letter to FDA Commissioner Robert Califf, urging him to reform the agency’s tobacco product application process, and asking him to explain and clarify the FDA’s approach to nicotine product regulation.

The letter, dated Dec.13, is signed by Republican senators Ted Budd (NC) and Rand Paul (KY), and Democrat Joe Manchin (WV).

Noting that the Tobacco Control Act requires the FDA Center for Tobacco Products (CTP) to review and decide on premarket tobacco product applications (PMTAs) and modified risk tobacco product (MRTP) applications within 180 days, the senators correctly note that the FDA has proven itself incapable of meeting review deadlines, and has authorized just a handful of non-combustible nicotine products.

“Since 2009,” they write, “more than 26 million premarket tobacco product applications (PMTAs) have been submitted for new tobacco products in the U.S. Of those 26 million applications, the CTP has authorized fewer than 50. Remarkably, it has also authorized a total of only 16 Modified Risk Tobacco Products (MRTPs) for only four unique products and their accessories. This miniscule authorization rate is not in keeping with the CTP policy acknowledging that tobacco products fall on a continuum of risk. The availability of scientifically substantiated, authorized-PMTAs or MRTPs could potentially improve health outcomes for smokers currently using riskier products.”

Since the FDA granted itself authority to regulate vaping products in 2016, the agency has authorized just seven e-liquid-based vaping devices for U.S. sale.

The senators cite the December 2022 Reagan-Udall Foundation report that concluded the CTP had largely failed as a regulator, before posing a series of questions to Califf:

• Does the agency prioritize its review of PMTAs or MRTPAs, and if so, what criteria does the CTP apply in that prioritization process?
• If the FDA does not prioritize its review of PMTAs or MRTPAs, do you agree there should be a prioritization strategy?
• There are FDA programs in place in other Centers that enable accelerated review of certain products that have the potential to benefit public health (e.g., breakthrough designation). Has the CTP considered whether and how such a concept could be integrated into its review program for tobacco products?
• Does the CTP support a supplemental PMTA process, and if so, what is the agency doing to (1) encourage use of the supplemental PMTA pathway and (2) implement ways to expedite decision-making on supplemental applications?
• Given the FDA’ s acknowledgment of a continuum of risk in nicotine-containing products, what is the agency doing to raise public awareness of the difference in risk between product categories and to encourage smokers to switch to less harmful products?
• The CTP’s assessment of whether a PMTA product is “appropriate for the protection of public health” includes an evaluation of the extent or likelihood that a product promotes complete switching or a significant reduction in combustible cigarette use in adult smokers. What specific scientific criteria does the CTP consider in this assessment, and how does it weigh or balance each of them in its final determination?
• Does the CTP apply any criteria to determine whether to provide applicants an opportunity to address application deficiencies before issuing a Refuse to Accept (RTA) decision? If so, what are those criteria?
• An article from the Society for Research on Nicotine and Tobacco recently called on the FDA to set a definition for premium cigars, saying that the failure to do so had prevented the agency from directing appropriate resources to riskier categories of tobacco products. Does the FDA agree with this approach and with establishing a separate category for premium cigars to promote risk-appropriate research and regulation?

The senators are asking Commissioner Califf to respond to their questions within 30 days.

Since 2016, when the FDA granted itself authority to regulate vaping products, the agency has authorized just seven e-liquid-based vaping devices for U.S. sale. The agency has not granted marketing permission for a single bottled-e-liquid, refillable vape product, or product in any flavor other than tobacco.

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