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Tell the FDA to Revoke OTC Status for Tylenol and Other Acetaminophen-Containing Products
August 13, 2026
On August 10, 2026, Children’s Health Defense (CHD) filed a Citizen Petition with the U.S. Food and Drug Administration (FDA) Acting Commissioner Kyle Diamantas requesting that the agency revoke OTC status for infants’ Tylenol and include boxed warnings on acetaminophen products for use by children under age six and obstetricians.
As the Defender article points out, our petition explains that a significant portion of all cases of regressive Autism Spectrum Disorder are chemically induced, and exposure of susceptible babies and children to acetaminophen is one such exposure that may play a significant role.
Read the cover letter and full petition.
A 2023 literature review by William Parker, PhD, et al found troubling associations between acetaminophen and serious impairments in cognition and socialization in susceptible children.
If your child has experienced adverse reactions to acetaminophen, or if you know of other children who have been adversely affected, we need you to let Acting Commissioner Diamantas know that you support this petition. Please submit a comment, spread the word far and wide, and encourage others to leave comments to maximize our impact.
When writing your comment, feel free to use the sample comment below or rework it to relay your thoughts on any adverse events you believe are connected to acetaminophen and the impact that has had on your family’s health.
Please also feel free to tell your own story including why revoking OTC status for infants’ acetaminophen is necessary, why boxed warnings are warranted, and why it is important to you and/or your family.
Thank you for taking action by using your voice to make a difference in this historic campaign to restore transparency and integrity to the FDA.
- Only the fields marked with red asterisks are required.
- Your comment can contain up to 5000 characters. If you are submitting a long personal comment, it’s best to write that comment first (in a document or a draft email to yourself), then copy and paste the text into the online form. That way, you will still have your comment text if the form submission fails on the first try.
- Choose “Individual Consumer” from the drop-down answers to “What is your comment about?”
- You may attach supporting documents if appropriate (up to 20 files of no more than 10MB each).
- You may file anonymously. Doing so removes some of the required fields.
- When filing as an individual, address and phone number are not required.
I support this call to revoke OTC status for Infants’ Tylenol and other similar acetaminophen-containing products, and to include boxed warnings on acetaminophen products for children under six and obstetricians. The potential for life-long damage to the health of our nation’s children in the absence of these actions is a very real threat.