The Food and Drug Administration (FDA) on Tuesday, Jan. 20, warned infant formula manufacturers that they remain fully accountable for product safety despite the absence of established safety limits, stressing that infant safety is “non-negotiable” amid the voluntary recall of certain products by Nestlé Philippines.

In a statement, the FDA said manufacturers are responsible for ensuring the “safety, quality, and integrity of products intended for infants and young children,” regardless of whether specific regulatory limits or definitive scientific thresholds are already in place.

“The absence of definitive scientific conclusions or established regulatory thresholds does not absolve manufacturers of their duty to ensure product safety, nor does it impede the FDA’s authority to take prompt and decisive action in the interest of public health, most especially when the safety of infants and young children is at stake,” the agency stressed.

The FDA said that “the absence of specific safety limits is not a shield against accountability,” adding that manufacturers of infant products are expected to exercise the “highest degree of precaution, even in the presence of incomplete or evolving scientific data.”

Citing the precautionary principle, the agency said reports of adverse symptoms, including “vomiting, diarrhea, and abdominal pain,” require immediate regulatory attention and intervention, even if a definitive causal link has yet to be established.

“When early indicators of potential harm emerge, particularly involving infants, the FDA will not wait for conclusive outcomes before acting. Our mandate is prevention, not reaction,” FDA said.

While acknowledging that voluntary recalls are “an appropriate and necessary step,” the FDA stressed that such actions do not end regulatory scrutiny. 

The agency said it continues to conduct ongoing assessments, coordinate with health authorities, and review supplier chains as part of its oversight functions.

“Public safety does not end with a recall announcement,” the FDA said. 

“Manufacturers must be prepared to demonstrate, at every stage, that their products meet the highest standards of safety, quality, and responsibility,” it added.

As such, the FDA warned that should similar incidents recur, or if ongoing investigations establish negligence or culpability, it would take “the full range of regulatory and legal actions necessary to safeguard public health.”

The agency assured the public that it continues to monitor reported cases, evaluate available scientific evidence, and implement all necessary regulatory measures, stressing that “the health and safety of infants and young children remain a non-negotiable priority.”