The Clay Travis and Buck Sexton Show
Episode: Tylenol Bombshell: Reporter Reveals Proof The FDA May Be Hiding The Truth
Date: October 29, 2025
Guests:
- David Rutherford (Guest Host)
- Emily Kopp (Investigative Journalist, Daily Caller)
Episode Overview
This episode spotlights blockbuster investigative reporting by Emily Kopp, who reveals internal FDA documents suggesting the agency has been aware for years of research indicating a potential link between Tylenol (acetaminophen) use during pregnancy and neurodevelopmental disorders, including autism and ADHD-like behaviors, yet repeatedly chose not to warn the public. The interview digs into the suppressed science, bureaucratic failures, and implications of this possible FDA cover-up, with added discussion of the ongoing class action lawsuit against Tylenol’s manufacturer.
Key Discussion Points & Insights
1. The Tylenol–Autism Controversy
[03:35–07:20]
- Background: A major article by Emily Kopp (Daily Caller) uncovers years of agency memos, epidemiology reports, and internal reviews that concluded by 2016 the FDA should warn pregnant women of acetaminophen’s potential risks—but the agency did not act.
- The FDA began investigating the link in 2014 after a landmark JAMA Pediatrics study raised concerns.
- By 2016, FDA Senior Medical Officer Andrew Mossholder had reviewed 8 observational studies—7 finding associations with attention deficits, delayed motor development, and autistic behaviors.
“FDA higher ups suppressed the recommendation year after year.”
— Emily Kopp [04:17]
- Despite mounting evidence, public communications from the FDA continued to downplay the risk, often referencing only the single 2014 study.
2. Suppressed Evidence and Internal FDA Debate
[07:20–12:33]
- Meta-Analyses vs. Dismissal: The oft-cited “one study” was a meta-analysis—a rigorous aggregation of existing studies, not a flimsy or isolated report.
- FDA drug safety reviewers repeatedly called for warning pregnant women—citing consistent associations (not causal proof).
- FDA Response: Instead of warning, higher-ups released a minimal 2015 notice and did not update further, even as more science accumulated.
- Kopp’s Methodology: She obtained extensive FDA documents via FOIA and class action suit discovery, painstakingly reviewed hundreds of files to ensure reporting integrity.
“These FDA reports clearly… stuck out.”
— Emily Kopp [11:12]
3. Redacted Animal Studies and Questions About Transparency
[12:33–15:27]
- The FDA also conducted independent toxicology studies on acetaminophen in animals.
- Results? Completely redacted from released documents.
“If the science truly indicates that there is no risk here, I think that’s something the FDA should inform the public of. But if there is a concern, then the public deserves to know that too.”
— Emily Kopp [14:57]
- Kopp’s investigative experience suggests inconvenient facts or embarrassing findings are often the reason for heavy redactions.
4. Bureaucratic Dynamics: Power, Inertia, and Influence
[22:47–29:35]
- Key FDA Players: Janet Woodcock, former acting FDA commissioner (40 years tenure), led the pivotal 2018 committee that again opted to “do nothing”—not even consider a warning label.
- Discussion of deep-rooted, unaccountable FDA bureaucrats paralleling figures like J. Edgar Hoover or Anthony Fauci.
- Woodcock oversaw the division responsible for OxyContin’s approval, often at odds with the FDA’s own advisors, and defended controversial opioid decisions.
“She was… a creature of the status quo.”
— Emily Kopp [26:10]
- Big Pharma Influence: The FDA receives “user fees” paid by the drug industry, introducing possible conflicts of interest and reinforcing “the status quo.”
5. Political and Systemic Factors in Drug Safety Decisions
[31:47–35:22]
- Pharmaceutical lobbying is often indirect; companies work through lawmakers who control the FDA’s budget.
- This indirect influence can shape agency actions without overt lobbying.
- Kopp notes parallels to OxyContin: a repeatedly-cited “foundational” paper suggested safety (for Tylenol, lack of liver toxicity), which may have diverted attention from other possible harm (neurological effects).
6. The Class Action Lawsuit Against Tylenol (Ken View)
[42:13–48:43]
- A major nationwide class action is underway; early efforts unsuccessful when the judge excluded plaintiff experts for failing to prove causation.
- Current Status: The case, initially litigated in Southern District of New York (Judge Denise Cote), is headed for appeal hearings in November.
“One thing that’s curious is that Biden’s Department of Justice weighed in… but they only cite one [FDA] report… that, unlike every other prior FDA report… didn’t have a recommendation section at all.”
— Emily Kopp [44:27]
- DOJ and the FDA’s most recent public documents downplay the causal link, omitting history of internal warnings. Ongoing legal maneuvering expected to reveal more.
7. The Culture of the FDA: Patterns of Suppression
[49:39–51:36]
- A historical parallel: The same epidemiologist urging Tylenol warnings also blew the whistle in 2003 on increased suicides in children on antidepressants—facing harassment and attempted suppression from FDA superiors.
- Only after Congressional inquiry did the FDA mandate a black box warning.
“An institution with that sort of culture… would it be capable of being responsible for a cover up of neurological damage of a major drug like Tylenol? I think it’s safe to say they would be capable of something like that.”
— Emily Kopp [51:00]
8. Implications & The Way Forward
- Americans’ skepticism of the FDA has been reinforced by recurring scandals—opioids, COVID vaccines, and now potentially Tylenol.
- The episode closes with appeals for more rigorous oversight, independent research, and public vigilance.
Notable Quotes
-
“FDA higher ups suppressed the recommendation year after year.”
— Emily Kopp [04:17] -
“He’s not calling for, you know, a public relations campaign against Tylenol… just saying we need to warn women about the potential for a risk.”
— Emily Kopp [07:20] -
“We don’t know [about the toxicology results] because for some reason… the FDA entirely redacted them.”
— Emily Kopp [13:57] -
“She (Janet Woodcock) was… a creature of the status quo.”
— Emily Kopp [26:10] -
“If the science truly indicates that there is no risk here, I think that’s something the FDA should inform the public of. But if there is a concern, then the public deserves to know that too.”
— Emily Kopp [14:57] -
“People… have this healthy skepticism of the FDA. And there’s this attitude in the press: how dare Kennedy challenge the science. But… these institutions need to prove they are following the science.”
— Emily Kopp [28:46]
Important Timestamps
| Timestamp | Topic | |---------------|----------------------------------------------------| | 03:35 | Introduction: Tylenol–Autism Story | | 04:17 | FDA’s Internal Reports and Suppression | | 07:20 | Nature of the Science & Meta-Analysis | | 11:12 | Kopp’s Document Review Process | | 12:33 | Redacted Animal Toxicology Studies | | 22:47 | Janet Woodcock & Bureaucratic Inertia at FDA | | 26:10 | Pattern of Unaccountable Power | | 31:47 | Financial Connections & Indirect Pharma Lobbying | | 35:22 | FDA–Big Pharma Symbiosis; Peer-Reviewed Evidence | | 42:13 | Overview of Class Action Lawsuit | | 44:27 | DOJ’s Maneuvering & Selective Citation | | 48:43 | Next Steps: Appeal in November | | 49:39 | FDA’s History: Suppression of Antidepressant Risks| | 51:36 | Systemic Trust Issues with FDA | | 53:27 | Secretary Kennedy’s Response to Reporting |
Memorable Moments
- The “one study” defense used by FDA and industry PR was exposed as a meta-analysis—undercutting their minimization of concerns. [07:20]
- Discovery of redacted animal study findings suggests potentially serious undisclosed risks. [13:57]
- The historical context of FDA suppressing whistleblower scientists (antidepressants in kids) reinforces a pattern of agency culture. [49:39]
- The parallel to OxyContin: “all over again” dynamic with foundational safety statements repeatedly cited, despite contradictory internal data. [35:22]
- Real-world implications for parents—host’s own experience reaching for Tylenol when children are sick. [29:35]
Closing Thoughts
The episode reveals an alarming pattern in which the FDA, faced with credible scientific evidence about potential risks of a ubiquitous drug, opted to protect institutional interests and industry relationships over issuing timely warnings. Systemic issues—unaccountable bureaucracy, industry influence, and selective transparency—are exposed through Kopp’s dogged reporting. With legal cases ongoing and future revelations likely, public trust in regulatory safeguards remains at stake.
Where to Follow Emily Kopp
- Reporting: The Daily Caller
- X (Twitter): @EmilyAnnKopp — DMs open for tips
For listeners seeking to understand the Tylenol–autism controversy, FDA integrity, and problems in U.S. drug regulation, this episode offers crucial insights, expert context, and a powerful call for independent investigation.
