DeLauro Introduces Bipartisan Infant Formula Safety Modernization Act

Press Release

Legislation comes in wake of ByHeart botulism outbreak 

Today, Congresswoman Rosa DeLauro (CT-03) introduced the Infant Formula Safety Modernization Act, comprehensive bipartisan legislation to modernize federal oversight of the nation’s infant formula supply and close longstanding gaps in testing, transparency, and regulatory enforcement.

“The food we give our babies must meet the highest standard of safety — no exceptions,” said Congresswoman DeLauro. “For too long, a resource-starved FDA has lacked the tools to adequately protect the infant formula supply. The recent ByHeart outbreak, which contaminated formula with Clostridium botulinum and sickened dozens of infants across the country, has further exemplified gaps in infant formula safety that are impossible to ignore. This legislation fixes that.”

The infant formula supply has faced two serious safety crises in recent years. In 2022, Abbott Nutrition’s Sturgis, Michigan facility — at the time responsible for roughly 40 percent of domestic formula production — shut down following Cronobacter sakazakii contamination, triggering a nationwide shortage that left families scrambling and babies sick. The crisis exposed how dangerously concentrated the U.S. infant formula market had become, and how lax food safety practices could cripple a highly consolidated market.

Now, a second outbreak has struck. Contamination of ByHeart infant formula with Clostridium botulinum sickened at least 48 infants across 17 states. Infant botulism, caused by bacterial spores that grow in a baby’s intestine and produce a toxin affecting the nervous system, can cause muscle weakness, poor feeding, a weak cry, and difficulty breathing, often progressing to paralysis. It is rare, but it is serious, and importantly, preventable.

The Infant Formula Safety Modernization Act would:

•      Expand required pathogen testing. Direct FDA to develop a comprehensive list of pathogens and microorganisms that infant formula manufacturers must test for — moving beyond the current requirement, which covers only Cronobacter and Salmonella. Clostridium botulinum would be required on that list.

•      Mandate environmental testing. Require standardized environmental monitoring inside infant formula facilities — a proactive practice that detects contamination in the production environment before it reaches the product. This testing is not currently required by law, despite its importance.

•      Set consistent testing standards. Specify the frequency of environmental testing so that all manufacturers operate under uniform FDA-set standards, rather than each company setting its own.

•      Require early FDA notification. Compel manufacturers to notify FDA of any positive pathogen test — even if the affected formula has not left the facility. Under current law, companies are not required to alert FDA unless adulterated formula has already entered the supply chain.

•      Hold foreign manufacturers to the same standards. Ensure that all infant formula sold in the United States — whether produced domestically or abroad — meets the same safety requirements.

•      Strengthen Congressional oversight. Require the Secretary to notify Congress of any confirmed positive pathogen test in finished infant formula, as well as any “Official Action Indicated” finding during an FDA facility inspection — the agency’s most serious compliance designation, requiring corrective on.

“Multiple crises year after year make clear that the current system is not working,” DeLauro concluded. “My Infant Formula Safety Modernization Act closes critical gaps to prevent the next outbreak before it occurs.”

The text of the legislation is available here.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.

Source: https://www.marlerblog.com/case-news/delauro-introduces-bipartisan-infant-formula-safety-modernization-act/