Kenvue is pushing back against movements to adjust Tylenol’s label.

President Trump’s administration unexpectedly put the painkiller in a difficult position when it announced that health officials believed there was evidence of a link between taking acetaminophen during pregnancy and autism. Officials went as far as to say that taking the medication while pregnant carries an increased risk of autism.

What is Kenvue requesting of FDA?

At the time, FDA Commissioner Makary issued a statement saying, “The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen. Even with this body of evidence, the choice still belongs with parents. The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don’t require treatment. It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.”

Kenvue, not surprisingly, has pushed back against these claims. A wide variety of health experts have also pushed back against the claims as well, with international health agencies announcing that they would not be taking similar actions against the medication.

Now, the company is formally requesting that FDA deny a Citizen Petition that seeks to change the pregnancy warning on Tylenol.¹ According to Kenvue, the claims made in the petition are not backed by existing science.

In a statement, Kenvue states that it believes the current warning is both conservative and appropriate. The warning says, “if pregnant or breast-feeding, ask a health professional before use.

Aside from the scientific objections to the petition, Kenvue also states that it believes this is an example of “overwarning.”

Kenvue writes, “There is significant value—as repeatedly recognized by FDA—in keeping OTC warnings concise, easily understandable, and calibrated. Because the science does not support a change to the warning language and the proposed labeling changes could be harmful to pregnant women and result in adverse pregnancy outcomes, Kenvue strongly opposes the changes and believes that the existing instruction to speak to a health professional before use in pregnancy is the most conservative and appropriate labeling.”

The statement continues to say that the proposed changes are not supported by scientific evidence and any changes to the labelling would a violation of the Administrative Procedure Act.

The petition was filed by the Informed Consent Action Network, a group that CNN describes as an anti-vaccine nonprofit.² According to the news outlet, the group announced plans to file the petition on the same day that President Trump made his remarks about the pain killer.

The group is requesting that the warning label directly state that research shows that the medication can increase the risk of autism and other neurological orders. It’s important to note, however, that studies have not shown a causal relationship between Tylenol and any neurological disorders.

Kenvue has repeatedly pushed back against the administration’s claims about a connection between the painkiller and autism.

In September, in response to President Trump’s initial comments, Kenvue said, “Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy. Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives. High fevers and pain are widely recognized as potential risks to a pregnancy if left untreated.”

Sources

1. Kenvue response to Citizen Petition. Kenvue. October 19, 2025. https://www.kenvue.com/kenvue-response-to-citizen-petition
2. Tylenol’s maker pushes back against possible label change linking pain reliever’s use in pregnancy to autism. CNN. October 20, 2025. https://www.cnn.com/2025/10/20/health/tylenol-fda-label-change