Under bipartisan Congressional legislation, baby formula manufacturers must notify the U.S. Food and Drug Administration (FDA) within 24 hours about product contamination in various circumstances to prevent and quickly halt any future outbreaks of cronobacter bacteria that resulted in severe baby formula shortages last year.
The formula shortage worsened after a recall caused by four babies getting sick from cronobacter, a rare bacteria, after drinking powder formula from the same Abbott Laboratories ABT plant.
Two of them died. Abbott said its products were not linked to the illnesses and that the FDA, the Centers for Disease Control and Prevention (CDC), and the company did not find any evidence of contamination at its plant.
The FDA also asked Congress to let it require formula makers to report cronobacter test results as part of its budget request.
After being notified of the contamination, the regulators would have 72 hours to contact the baby formula maker.
Before distribution, formula makers must test formula samples for contamination and keep records. They only need to inform regulators if they suspect contamination in formula already in stores, the Wall Street Journal noted, citing an FDA spokesperson.
The bill aimed to give the FDA more power and responsibility to get answers from formula makers to protect babies from bacterial infections.
The House Oversight Committee’s Health Care and Financial Services was outraged at two hearings this year about the formula recall and shortages that caused stress for many parents, including some lawmakers.
ABT Price action: Abbott Laboratories shares are up 0.50% at $103.27 on the last check Tuesday.
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