Safe Food Coalition urges FDA to strengthen inspection and regulation of infant formula in the wake of ByHeart botulism outbreak

The Safe Food Coalition is urging the Trump administration to take immediate action to protect the safety of infant formula following the outbreak of Clostridium botulinum infections linked to ByHeart infant formula. The ongoing outbreak, with 37 confirmed cases so far, has exposed dangerous deficiencies in the inspection and public health systems that should ensure the safety of the nation's youngest and most vulnerable consumers, according to the coalition.

In a letter to Secretary of Health and Human Services Robert F. Kennedy, Jr., Food and Drug Administration Commissioner Martin Makary, and Centers for Disease Control and Prevention Acting Director Jim O'Neil, the Safe Food Coalition urged the administration to strengthen the inspection and regulation of infant formula, and to declare Clostridium botulinum to be a hazard requiring preventive controls to prevent contamination.

To strengthen the formula inspection program, the Safe Food Coalition recommends filling vacant inspector positions-currently at 40 percent-and reinstating FDA's inspector training program. The FDA should increase inspection of formula facilities, the coalition says, and fully fund the inspection program-including funding for state-level inspections.

Besides declaring Clostridium botulinum contamination in infant formula to be a hazard, the coalition recommends the administration develop recommendations for best practices to avoid Clostridium botulinum contamination and conduct a sampling program for Clostridium botulinum in formula. The administration should issue recommendations to companies on appropriate testing and facilitate swift recalls by promptly sharing information with state enforcement agencies, according to the letter. And the administration should fully fund chronically underfunded food safety work conducted within the CDC, including vital foodborne illness surveillance activities like FoodNet.

The coalition says greater scrutiny of ByHeart's operations, including the Iowa production facility linked to the ongoing outbreak, may have prompted an earlier recall and avoided illnesses.

"The nation's food safety system is on the brink of collapse," said CSPI director of regulatory affairs Sarah Sorscher. "Forty percent of the personnel who inspect infant formula and other critical foods are not at their posts. That means the FDA has less flexibility to deploy its resources in response to outbreaks like the current ByHeart outbreak."

"Contaminated infant formula puts the nation's most vulnerable consumers at risk, and it is an indictment of our food safety system as a whole," said Thomas Gremillion, Director of Food Policy at Consumer Federation of America. "Over three years have passed since a Cronobacter outbreak linked to infant formula caused a nationwide shortage, and we see more inspector vacancies and less capacity for outbreak surveillance than ever."

Finally, the Safe Food Coalition says the administration should work with Congress where necessary to establish adequate authority and funding to create effective infant formula protections, citing several pieces of legislation pending in Congress.

The Safe Food Coalition includes the Center for Food Safety, Center for Science in the Public Interest, Consumer Federation of America, Consumer Reports, Government Accountability Project, GWU Institute for Food Safety and Nutrition Security, and Stop Foodborne Illness.

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