Tell the FDA: Formula Companies Must Report Harm to Babies

Formula companies should never be allowed to hide possible harm to babies.

But when infants get sick or die while receiving formula, manufacturers have far too much power to decide whether the FDA ever hears about it. And new reporting from KFF Health News shows that hasn't changed, even after years of formula-safety failures.

Parents trust formula companies with their babies’ lives. The FDA must make sure that trust is not abused. If a serious illness, hospitalization, or death may be connected to infant formula, regulators should know immediately — not only when a company decides the information is worth sharing.

Tell the FDA: Stop letting formula manufacturers police themselves. Require them to report possible harm to babies immediately and completely.

Babies cannot speak for themselves. Premature infants and medically fragile newborns are especially vulnerable. Their families deserve transparency, urgency, and real oversight — not a system that lets corporations decide what safety warnings stay behind closed doors.

The FDA cannot spot dangerous patterns if reports never arrive. Doctors cannot warn families about risks they never see. And parents cannot protect their children if the companies selling formula are allowed to keep possible warning signs out of public view.

After years of failures that harm children, the FDA cannot wait for another crisis before closing this loophole. It must strengthen reporting rules, audit formula manufacturers, demand full disclosure, and impose real consequences on companies that fail to report possible harm.

Add your name now to demand the FDA put babies’ lives ahead of formula-industry profits.

The petition to Acting FDA Commissioner Kyle Diamantas reads:

“Require infant formula manufacturers to immediately report all serious adverse events, hospitalizations, and deaths potentially linked to their products. Audit manufacturer compliance, strengthen FDA oversight, and impose meaningful penalties on companies that fail to disclose possible harm. Babies’ safety must come before corporate profits.”