Tylenol Maker Opposes FDA Label Change on Pregnancy-Autism Link

Kenvue, the manufacturer of Tylenol, is challenging a proposed FDA requirement to update the pain reliever's safety label with warnings about potential connections between acetaminophen use during pregnancy and autism diagnoses in children.

In a statement, the company called the proposed revisions "arbitrary, capricious, and contrary to law," arguing against adding the warnings to Tylenol packaging.

The dispute follows comments from President Donald Trump last month, encouraging pregnant women to stop taking acetaminophen. Trump claimed the medication's active ingredient is linked to autism, though he provided no scientific evidence for this assertion.

Tylenol's current safety label instructs pregnant or breastfeeding individuals to consult a healthcare professional before using the product.

According to medical professionals and existing research, acetaminophen remains considered safe for use during pregnancy. The medication is one of the few pain relievers recommended for pregnant women when medically necessary.

The FDA has not announced a timeline for any potential label changes.