“A damning, meticulously documented indictment of an underregulated public health risk.” – Kirkus Reviews

Agents of the Current Thinking reveals the culture at the U.S. Food and Drug Administration as a fundamental barrier to effective tobacco regulation and public health protection. For advocates, this underscores the urgent need for greater transparency, accountability, and protections of scientific integrity within the FDA. Only by addressing these failures can the agency truly serve the public interest and safeguard health.

FDA Culture: A Public Health Advocacy Perspective

Leadership Prioritizes Expediency and Self-Preservation Over Public Health The book documents how FDA leadership within the Center for Tobacco Products routinely prioritized meeting review deadlines, avoiding litigation, and protecting the agency's image over ensuring robust, science-based regulation. Regulatory decisions were often predetermined to facilitate the sale of tobacco products, even when scientific evidence was lacking or contradictory. This undermines the FDA's core mission to protect public health.

Suppression of Scientific Integrity and Whistleblowing Scientists who raised concerns about misleading data, unscientific practices, or public health risks faced retaliation, isolation, or career threats. Whistleblower protections were weak in practice, and internal processes meant to safeguard scientific integrity were manipulated to suppress dissent. This culture discouraged open discussion and corrections of flawed science, directly impacting the quality of regulatory decisions.

Lack of Transparency and Accountability Leadership avoided putting scientific standards and procedures in writing, making it difficult to correct errors or put a stop to misconduct. Key information about product risks and the agency’s regulatory rationale was hidden from the public and even from staff, undermining transparency and informed public debate. External communications often misrepresented the rigor and integrity of the FDA's work.

Normalization of Unethical Behavior Employees were pressured to comply with questionable directives, such as misrepresenting data or ignoring known harms, to maintain their jobs. Those who resisted were marginalized. Over time, this creates a culture where unethical behavior is normalized.

Direct Public Health Consequences The book provides concrete examples where flawed regulatory processes moved tobacco products on the U.S. market without adequate scientific review, putting millions at risk—especially youth and vulnerable populations. The FDA failed to inform the public about known risks (e.g., lead exposure), and assessments were crafted to avoid raising red flags, rather than to protect health.

Erosion of Public Trust By prioritizing the agency’s image and expediency over transparency and scientific rigor, FDA leadership eroded public trust. The book argues that this loss of trust makes it harder for the agency to fulfill its public health mission and undermines confidence in all FDA-regulated products.

“And while the book doesn’t shy away from noting the ways that the second Trump administration continues to endorse policies that defy science, it also offers a sweeping bipartisan critique of both parties.” – Kirkus Reviews

There are real reasons regulatory science work is challenging. It is the intersection of science and policy and aims to inform the implementation of laws that ensure the safety of things like consumer products and drugs. But the science sometimes isn’t ready to inform what policy and the public need, and delays for science can delay commerce.

Agents of the Current Thinking is the story of an agency grappling with a history and precedent of facilitating commerce before science informs decision making, where the outcome risks the public health. 

  • In December 2022, the U.S. Office of Special Counsel alerted the President and Congress that the FDA Center for Tobacco Products “relaxed its standards of review for certain tobacco products and stifled concerns raised by its scientists.” Special Counsel Henry Kerner said, “The public depends on the FDA to vigorously implement and enforce our nation's health and safety laws, especially when new tobacco products are being brought to market.”

  • Likewise, the December 2022 Operational Evaluation of FDA’s Tobacco Program by the Reagan-Udall Foundation reported problems. Outcomes of that evaluation and the wrongdoing disclosure included new messaging about scientific integrity at the Center for Tobacco Products.

  • Earlier that year, in April 2022, the U.S. Government Accountability Office published, Scientific Integrity: HHS Agencies Need to Develop Procedures and Train Staff on Reporting and Addressing Political Interference. That report says, “Since 2007, Congress and multiple administrations have taken actions to help ensure that federal science agencies have scientific integrity policies and procedures in place that, among other things, protect against the suppression or alteration of scientific findings for political purposes.” 

  • That report found the FDA “did not identify any formally reported internal allegations of potential political interference in scientific decision making from 2010 through 2021,” because there was no process to do that. It defines scientific integrity as “the use of scientific evidence and data to make policy decisions that are based on established scientific methods and processes, are not inappropriately influenced by political considerations, and are shared with the public when appropriate.” 

  • As an outcome of that report, in December 2023, a new Scientific Integrity Policy was adopted at FDA. That report says, “The FDA Commissioner should ensure that procedures for reporting and addressing potential political interference in scientific decision-making are developed and documented.”

Then during his 2024 campaign, President Trump wrote that he’d “saved Flavored Vaping in 2019” and would “save Vaping again!” The New York Times reported a $5 million tobacco industry donation to MAGA Inc. on April 30, 2026, then new FDA guidance facilitated the U.S. sale of vapes. And on May 5, 2026, The Wall Street Journal reported that President Trump pressured FDA Commissioner Makary to authorize flavored vapes, and he did it. 

Imagine what it takes for Executive Branch scientists to contort their work to accommodate top-down directives to authorize tobacco products. Consider the pressure to comply when many federal employees have been eliminated and when our justice system is weaponized against those who don’t. Imagine the market of questionable products that persists after years of uncorrected political influence. 

Agents of the Current Thinking shares what’s experienced inside an agency where its scientists struggle to align science with predetermined top-down directives.

“With a PhD in biological sciences, Leppanen has a solid grasp on the underlying science, which she condenses into an accessible writing style for lay readers.” – Kirkus Reviews

In May 2025, President Trump signed Executive Order 14303, Restoring Gold Standard Science that says, “Over the last 5 years, confidence that scientists act in the best interests of the public has fallen significantly.” 

It says, “Unfortunately, the Federal Government has contributed to this loss of trust.” 

It describes policies where science informs agency decisions and oversight corrects shortcomings.

It says agencies must implement Gold Standard Science that is transparent and without conflicts of interest, and disclose “data, analyses, and conclusions associated with scientific and technological information produced or used by the agency.”

It says, “Scientific integrity in the production and use of science by the Federal Government is critical to maintaining the trust of the American people and ensuring confidence in government decisions informed by science.” 

It says, “My Administration is committed to restoring a gold standard for science to ensure ... Federal decisions are informed by the most credible, reliable, and impartial scientific evidence available.”

The same expectations are described in FDA’s August 2025 implementation of Gold Standard Science at FDA after it says, “No concern is more central to the proper functioning of FDA than the need to ensure that the science underlying agency decisions is sound.” 

It says, “The agency is committed to a culture of openness in its interactions with the public.”