The Food and Drug Administration is too often an unaccountable $7 billion bureaucratic black box that burdens taxpayers and leaves businesses in the dark.
Despite some recent encouraging news about marketing authorizations of reduced-risk products, a September 2026 report from the Government Accountability Office shows that much work remains to be done. The report reveals that, from 2018 to 2025, the FDA took an average of 507 days to complete its review of tobacco product applications. Even worse, despite receiving billions in taxpayer dollars and industry user fees, the agency’s internal data-tracking systems are so deeply broken that the FDA cannot even monitor whether it is meeting its own scientific review deadlines.
When a federal regulator routinely misses its own 7-day or 180-day goals, sometimes by hundreds of days, it’s time for reform and accountability.
The report highlights the deeply disturbing reality that the FDA does not know how to track its own work. And although the agency is legally required to rule on premarket tobacco product applications within 180 days, its internal databases are designed to overlook the detailed steps involved in scientific reviews. It is impossible to manage what is not measured. Taxpayers are funding an expensive regulatory apparatus that operates, in effect, on a blindfolded “hope for the best” approach.
The FDA’s massive regulatory backlog has profound consequences for smoking cessation. Confining tobacco harm reduction products to regulatory purgatory simply shifts the entire supply chain to a dangerous and unregulated black market. When the FDA takes an average of 507 days to process basic applications and leaves more than 132,000 applications languishing, the agency embraces de facto prohibition — an approach that has failed miserably. During the late 19th-century “Butter-Margarine War,” aggressive state bans and discriminatory yellow-tint taxes on oleomargarine failed to protect dairy cartels, instead driving widespread illicit sales, underground color-dyeing, and rampant product mislabeling.
In the early 20th century, alcohol prohibition directly fueled the rise of violent syndicates and figures such as Al Capone. Decades later, the “War on Drugs” followed the exact same trajectory, spending more than a trillion taxpayer dollars while failing to reduce drug availability, instead inflating cartel profits and fueling unprecedented incarceration rates. When there aren’t enough regulated products to meet demand, consumers go elsewhere.
This regulatory failure also hits taxpayers directly in the wallet. A broken regulatory framework drives legitimate small businesses to shut their doors because they cannot afford years of legal limbo. Meanwhile, the booming illicit trade operates entirely outside the tax base, stripping state and federal governments of legitimate revenue. In 2025, the FDA and U.S. Customs and Border Protection seized nearly $34 million worth of unauthorized e-cigarettes in a joint operation.
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Federal officials reported that many shipments originated in China and included inaccurate descriptions or declared values, showing how illicit suppliers can try to circumvent border controls and regulatory oversight. The World Health Organization estimates that approximately 1 in 10 tobacco products consumed globally are illicit and describes the illicit tobacco trade as a major health, economic, and security concern. The WHO reported in 2025 that the illicit tobacco trade accounts for approximately 11% of the global tobacco market and costs governments more than $47 billion in tax revenue annually.
Congress must hold the FDA accountable for failing to review products in a timely manner and demand transparency and reform to clear the bureaucratic backlog. To protect consumers and taxpayers and keep pace with consumer demand, the FDA must also establish a fast-track pathway for low-risk products, with clear timelines and regulations. A few commonsense reforms can go a long way toward protecting public health and curbing black markets.
Christina Smith is the director of the Taxpayers Protection Alliance’s Consumer Center.