September 23, 2025
Autism Innovation Lab (AIL) Responds to Presidential Remarks on Autism, Acetaminophen, and Leucovorin
San Diego, CA – The Autism Innovation Lab (AIL) today issued the following statement regarding President Trump’s remarks suggesting that acetaminophen (Tylenol) use during pregnancy “causes” autism:
“We believe the President’s statement is a political statement — not a medical directive, not a CDC recommendation, not a peer-reviewed conclusion, and not a scientifically proven fact. It is irresponsible to frame it otherwise. The only thing worse than denying struggling autism families any hope for the future is spreading false hope based on misinformation. Autism is not caused by a single factor or medication. It is a lifelong condition shaped by a complex interplay of genetics, biology, and environment. Suggesting otherwise undermines decades of rigorous scientific research, threatens public health, and distracts from the real work of supporting families and advancing inclusion,” said Shahriar Afshar, Founder of the Autism Innovation Lab.
While scientists continue to explore autism’s multifactorial causes, the overwhelming consensus is that there is no credible evidence linking acetaminophen or vaccines to autism. Acetaminophen remains the safest over-the-counter option for pain and fever during pregnancy, according to the American College of Obstetricians and Gynecologists (ACOG), the Society for Maternal-Fetal Medicine (SMFM), and the FDA. By contrast, NSAIDs such as ibuprofen and aspirin carry well-documented risks in pregnancy, including low amniotic fluid and fetal kidney complications.
What the Science Actually Shows
- A 2024 Swedish sibling-control study of 2.5 million children found no causal link between maternal acetaminophen use and autism, ADHD, or intellectual disability.
- ACOG and SMFM reaffirm acetaminophen’s safety when medically indicated.
- The CDC and American Academy of Pediatrics reiterate that vaccines are not associated with autism.
- U.S. federal courts have dismissed Tylenol-autism lawsuits, ruling expert claims failed scientific reliability standards.
Why Harvard Is in the Headlines
A recent 2025 Harvard/Mount Sinai review, led by Dr. Andrea Baccarelli, Dean of Public Health at Harvard, pooled 46 earlier studies and found some evidence of association between prenatal acetaminophen use and neurodevelopmental outcomes. Importantly, the authors emphasized this does not prove causation and recommended only judicious, medically guided use — not bans or political decrees. Selective use of this study to justify sweeping claims is misleading and dangerous.
On Leucovorin (Wellcovorin) Claims
The Administration also announced FDA “approval” of leucovorin (folinic acid) for autism. This claim is misleading and incomplete:
- Leucovorin is an established cancer therapy, not an FDA-approved autism treatment.
- Small clinical trials suggest possible benefit in subsets of children with cerebral folate deficiency (CFD) or certain autism profiles, but these findings are preliminary.
- No FDA indication exists for autism, no large-scale replication has been completed, and it should not be presented as a proven therapy.
Portraying leucovorin as a breakthrough cure risks exploiting vulnerable families by overselling unverified science.
What AIL Stands For
- Science & Evidence: Peer-reviewed research, medical integrity, and transparency guide our work.
- Education & Empowerment: We equip families, businesses, and policymakers with the knowledge and tools that foster meaningful inclusion.
- Community Integrity: We protect autistic individuals and families from misinformation and exploitation.
- Innovation & Opportunity: We create new pathways in housing, entrepreneurship, and inclusive business certification that drive both social and economic impact.
About AIL
The Autism Innovation Lab (AIL) is a Delaware Public Benefit Corporation that accelerates science-based autism and inclusion startups, invests in innovative solutions, and builds economic pathways for families and entrepreneurs through its subscription-based ecosystem. For more information, please contact Shahriar Afshar at info@AutismInnovationLab.com or visit www.AutismInnovationLab.com.