ICYMI: Regulate Smarter Chair Richard Burr Keynotes FDLI Summit
Addressing the “Tobacco and Nicotine Products Regulation and Policy Conference” in Washington, D.C., Burr praises Food and Drug Administration’s recent progress while stressing the need for further reforms to reverse the failed status quo, establish a well-regulated marketplace
WASHINGTON, D.C. – In a keynote address before the Food and Drug Law Institute’s (FDLI) Tobacco and Nicotine Products Regulation and Policy Conference in Washington, D.C., Richard Burr, chairman of the Coalition for the Smarter Regulation of Nicotine (Regulate Smarter) heralded recent progress from the U.S. Food and Drug Administration (FDA), while reminding attendees that “we still have a long way to go” toward establishing a well-regulated marketplace that will reduce the illicit market to a crisis of the past.
Among the highlights of Burr’s comments:
Industry Has Done Its Part: Since the 2009 passage of the bipartisan Family Smoking Prevention and Tobacco Control Act, FDA has collected more than $10 billion dollars in user fees from manufacturers for product reviews, compliance and enforcement, public education campaigns, and other regulatory activities. Yet, today an estimated 85 percent of the nicotine product market remains illicit.
Burr: “My concern then was that FDA would unintentionally lock in the most risky products under the grandfathering provision and then set impossible standards for new, lower-risk products – essentially blocking new and advanced reduced-harm products from entering the market and depriving adult consumers of the thing they want most: choice.”
GAO Report Lays Bare FDA Shortcomings: According to a report published last week from the Government Accountability Office (GAO) – a non-partisan, trusted entity charged with investigating federal spending and performance – between 2018 and 2025, FDA has taken on average 507 days to review tobacco product applications, far exceeding the 180-day timeline required by Congress in the Tobacco Control Act.
Burr: “A major backlog of applications still sit with FDA – almost 132,000 applications remain pending, most of which have been waiting for an FDA decision for at least two years. A two-year wait time would devastate any company looking to engage in the legal marketplace and continue investing in innovative technologies.”
Dr. Koplow’s Comments Were Encouraging: FDA’s recent appointment of Dr. Bret Koplow to official Center Director of CTP is a welcome one, as are some of his early decisions.
Burr: “I was encouraged to hear Dr. Koplow’s clear commitment to revising and strengthening the premarket pathway. I was glad to hear his perspective that enforcement, authorization, and education are the key elements to building a foundation for a legal, robust marketplace that prioritizes public health. I’m just sorry it’s taken 17 years to have an FDA that recognizes these ingredients as being absolutely crucial.”
FDA’s Announced Plans To Evaluate Changes To The PMTA Regulatory Framework Is Long Overdue. FDA’s deadlines had required companies to submit applications before it shared details about what those applications should contain in order to meet its scientific and administrative review standards.
Burr: “In 2021, during the confirmation hearing of former FDA Commissioner Califf, I raised concerns about manufacturers submitting applications for new, less-harmful tobacco products before the agency provided a roadmap for its review expectations – which took FDA 10 years to issue. How can you go on a road trip without a map to your destination?”
July’s Publication By The Journal Of The American Medical Association (JAMA) Was A Watershed Moment. One of the world’s most prestigious medical journals called for the integration of FDA-authorized e-cigarettes into patient-centered conversations about smoking cessation to help adult smokers move away from cigarettes and reduce the harms of smoking.
Burr: “JAMA leaves no doubt that FDA-authorized e-cigarettes are less harmful alternatives that can serve as legitimate smoking-cessation tools for adults and underscore the need for FDA to accelerate the authorization of more smoke-free, quality-controlled products.”
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