A group of consumer advocate organizations has asked top health officials to take immediate action to protect the safety of infant formula.
The Safe Food Coalition says the federal government needs to act now to prevent another outbreak of botulism infections like the ongoing one traced to ByHeart powdered infant formula. So far there are 51 confirmed patients spread across 19 states. All of the sick babies have required hospitalization and many have had to be put on ventilators.
The coalition is made up of 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.
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 coalition asked that Clostridium botulinum be declared to be a hazard requiring controls to prevent contamination of infant formula.
The coalition also wants the government to develop recommendations for best practices to avoid Clostridium botulinum contamination in infant formula based on a root cause assessment of the ongoing outbreak. The government should also conduct a sampling program for Clostridium botulinum in infant formula and issue recommendations to companies on appropriate testing for indicator organisms.
Staffing at the Food and Drug Administration is also a concern cited by the coalition.
“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,” the coalition stated.
“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’s letter cited problems at the ByHeart infant formula production plant including signs of unsanitary conditions like mold and insect infestations, that were listed in FDA inspection reports. No follow up action was taken. The coalition suggests that a lack of FDA staff contributed to the problem.
“. . . with 40 percent of infant formula and other ‘critical foods’ inspector positions vacant, FDA has limited capacity to redirect inspection resources in response to unsanitary conditions like the ones found at ByHeart. Cuts to the agency’s administrative staff and laboratory scientists, as well as new bureaucratic hurdles in the budget approval process, have reportedly limited the effectiveness of the inspectorate that remains,” the coalition told the health leaders in the letter.
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.”
Another leader in the coalition shared Sorscher’s concerns.
“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.”
The Safe Food Coalition says President Trump’s Administration should work with Congress to establish adequate authority and funding to create effective infant formula protections, citing several pieces of legislation pending in Congress.
In particular, the coalition’s letter states, the FDA should declare Clostridium botulinum contamination to be a hazard requiring preventive controls, which manufacturers must address in their food safety plans. The agency should develop recommendations for best practices to avoid Clostridium botulinum contamination based on a root cause assessment of the ongoing outbreak, and conduct a sampling program testing infant formula for Clostridium botulinum.
“Operation Stork Speed (a government initiative announced earlier this year regarding infant formula) should include increased testing for microbiological contaminants, as well as for heavy metals and nutritional adequacy. Finally, FDA should offer guidance to companies on incorporating recommendations for routine testing for Clostridium botulinum indicator organisms, which were drafted by the International Commission on Microbiological Specifications for Foods in 2014,” the coalition letter states.
The letter also addresses the botched recall of the contaminated ByHeart formula. The coalition says the FDA should investigate the underlying cause of delays that have hampered the recall of ByHeart formula, citing the fact that weeks after the announcement of the recall FDA reported major retailers including Walmart and Target were continuing to sell the product.
“Notably, a lengthy process was reportedly needed before FDA would agree to release the names of retailers to state regulators, a process that can and must be streamlined not just with respect to recall communication, but for all communication with state regulators,” the coalition said.
The group of consumer advocates also called on HHS Secretary Kennedy to fully fund the Centers for Disease Control and Prevention saying that the agency’s food safety program played a vital role in solving the ByHeart outbreak. The coalition contends that inadequate CDC funding was reflected recently in cuts to the agency’s FoodNet surveillance system, which was scaled back dramatically from covering eight foodborne pathogens to only two. In addition to the FoodNet system, the CDC’s role in foodborne disease surveillance has been hampered by budget cuts. Roughly half of the agency’s food safety budget has traditionally been distributed to the state and local agencies that form the backbone of surveillance efforts.
“Identification of illness clusters leads to outbreak detection which, in turn, leads to root cause analyses that inform good manufacturing practices that, in turn, improve the safety of the food supply,” the coalition wrote to Kennedy and the other food safety leaders. “Without adequate funding, however, this feedback loop breaks down. . . . The Administration should support a 50 percent increase to the CDC’s food safety budget. . .”
Finally, the Safe Food Coalition called on Kennedy and the other two food safety administrators to work with Congress to establish adequate authority and funding to create effective infant formula protections. Bills to help do this include:
o The Federal State and Food Safety Information Act, which would allow FDA to share timely information with the states to conduct recall checks;
o The Protect Infant Formula from Contamination Act, which would require companies to report positive test results in infant formula to the FDA;
o The Improving Newborns’ Food and Nutrition Testing Safety (INFANTS) Act, which would require additional product and environmental testing for formula, mandate reporting of product positives, facilitate remote records access, and provide additional recall authority; and
o The Baby Food Safety Act of 2024, which would require environmental monitoring in facilities producing formula and baby food.
