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# Ban Infants’ Tylenol: Children’s Health Defense
- URL: https://www.fdaweb.com/ban-infants-tylenol-childrens-health-defense/
- Published: 2026-08-12T12:00:00.000Z
- Updated: 2026-09-14T13:45:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161613

In a 64-page petition, Children’s Health Defense calls on FDA to withdraw over-the-counter approval for Infants’ Tylenol and other products containing acetaminophen approved for use with children under age two. The [petition](https://downloads.regulations.gov/FDA-2026-P-9046-0001/attachment%5F1.pdf?ref=fdaweb.com) also asks the agency to require a Boxed Warning and other safety information concerning the severe risk of autism spectrum disorder for Children’s Tylenol and other products containing acetaminophen for children under age six, and require a Boxed Warning for Tylenol and other products containing acetaminophen relevant to labor and delivery.

Many view Children’s Health Defense as highly controversial and a leading source of vaccine misinformation and anti-vaccine activism, functioning as a primary driver of the modern anti-vaccine movement. Public health experts, major medical organizations, and scientific researchers widely condemn the group for promoting thoroughly discredited theories and undermining confidence in life-saving public health measures. It was originally founded by HHS secretary Robert F. Kennedy Jr., who left the group before he began campaigning for president in 2023.

A cover letter to the petition says that it contains conclusions of WPLab scientists (a private lab founded by chemist **William Parker**) who claim 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. Of course, this is not the only risk with these products, but this association is one that has been ignored for too long.”

The petition says that given the continued use of acetaminophen during labor and delivery, and routine use during infancy and early childhood, including for indications such as circumcision, vaccination, and some chronic medical conditions, FDA action is much needed.

It cites President **Donald Trump**’s 9/23/2025 statement that since 2000, autism cases have surged by much more than 400%, and his flat assertion that pregnant women should not take Tylenol and parents should not give Tylenol to their children. It also says that HHS, under secretary Kennedy, recognized Tylenol’s association with autism spectrum disorder and attention deficit/hyperactivity disorder when the department said in 2025 that FDA would begin the process to order a safety labeling change.

“This petition takes the HHS announcement one step further,” it says. “We ask that FDA ban OTC Infants’ Tylenol and other similar products containing acetaminophen. This petition also asks that the commissioner require Boxed Warnings for use during labor and delivery and, for Children’s Tylenol and other similar products containing acetaminophen, up to a child’s sixth birthday. It is time for the commissioner to take the requested, decisive action.”