Three U.S. Senators Ask FDA Commissioner to Clarify Tobacco Product Certification Standards

On December 13, 2023, U.S. Senators Ted Budd, Rand Paul, and Joe Manchin submitted a letter to FDA Commissioner Robert Califf requesting reform of the FDA's tobacco product application process and clarification of the standards for regulating nicotine products, stating that " 1) the FDA has not met deadlines for reviewing applications under the Tobacco Control Act, and 2) the number of tobacco products approved by the FDA is extremely low, " and asked for a response within 30 days.

  1. FDA misses deadline for review of tobacco control law applications

    The FDA's Center for Tobacco Products (CTP) is required to review and act on premarket applications (PMTAs) and applications for marketing as "reduced risk tobacco products" (MRTPs) within 180 days of submission (Tobacco Control Act).
    However, senators now reveal that the FDA's Center for Tobacco Products has actually failed to meet its review deadlines .

  2. The FDA (Food and Drug Administration) has approved very few cigarettes.
    Since 2009, more than 26 million premarket tobacco applications (PMTAs) have been submitted in the United States. However, the FDA's Center for Tobacco Products (CTP) has approved only four "Modified Risk Tobacco Products" (MRTPs), and only 16 including ancillary products.

    Additionally, the FDA has only approved seven nicotine vape products since it began approving them in 2016. It has not approved any bottled nicotine liquid products, refillable nicotine vape products, or non-tobacco flavored products.

    The extremely low number of approvals from the FDA's Center for Tobacco Products contradicts the Center's own policy that " the risks of tobacco products should be diverse . "

    If the FDA Center for Tobacco Products were to approve new tobacco products and reduced-risk cigarettes based on science , it could potentially improve the health of current high-risk smokers .

  3. Questions in the US Senators' Letter
    The senators cited a December 2022 Reagan-Udall Foundation report concluding that the FDA's Center for Tobacco Products (CTP) had failed to regulate tobacco products, and submitted a letter of inquiry to FDA Commissioner Robert Califf, which included the following questions:
    • Does FDA prioritize its review of premarket tobacco applications (PMTAs) or "modified risk tobacco products" (MRTPs) and, if so, what are the FDA Center for Tobacco Products' prioritization criteria?

    • If the FDA isn't prioritizing the review of tobacco premarket applications and modified-risk tobacco products, do you think it should?

    • Other agencies have programs at FDA that allow for the expedited review of tobacco products that may benefit the public health. Has the FDA Center for Tobacco Products included or is considering including such concepts in its review of tobacco products?

    • Does the FDA's Center for Tobacco Products support the move to amend and supplement tobacco premarket applications, and if so, what is the FDA doing to proactively amend and supplement tobacco premarket applications and expedite decision-making on those applications?

    • Given that FDA recognizes that the risks of nicotine products vary, what is FDA doing to raise public awareness of the differences in risk among products and encourage smokers to switch to less harmful products?

    • FDA's Center for Tobacco Products' evaluation of whether a pre-market tobacco product is "appropriate for the public health" includes an assessment of its potential to influence adult smokers to make new product choices based on health risks or to promote substantial reductions in cigarette smoking.
      What specific scientific evidence does the FDA's Center for Tobacco Products use in this evaluation, and how does it weight and balance each of the criteria in its final decision?

    • Does the FDA Center for Tobacco Products have standards for providing applicants an opportunity to address deficiencies in their applications before issuing a Refuse to Accept (RTA) decision? If so, what are those standards?

    • The Society for Research on Nicotine and Tobacco recently called on the FDA to define premium cigars. Does the FDA support this approach, and would it support creating a separate category for premium cigars to encourage risk-based research and regulation?

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