A group of consumer rights 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 immediately to prevent another outbreak of botulism infections like the current one caused by ByHeart powdered infant formula. There are currently 51 confirmed patients in 19 states. All sick babies required hospitalization, and many had to be placed on ventilators.
The coalition includes the Center for Food Safety, the Center for Science in the Public Interest, the Consumer Federation of America, Consumer Reports, the Government Accountability Project, the GWU Institute for Food Safety and Nutrition, and Stop Foodborne Illness.
In a letter to Secretary of Health and Human Services Robert F. Kennedy Jr., Food and Drug Administration Commissioner Martin Macari, and Acting Director of the Centers for Disease Control and Prevention Jim O'Neill, the coalition asked that Clostridium botulinum be declared a hazard that requires control to prevent contamination of infant formula.
The coalition also wants the government to develop best practice guidelines for the prevention of Clostridium botulinum. contamination of infant formula based on an assessment of the root causes of the ongoing outbreak. The Government should also undertake a sampling program for Clostridium botulinum in infant formula and provide guidance to companies on appropriate testing for indicator organisms.
The coalition also cites Food and Drug Administration staffing as a problem.
“To strengthen the formula inspection program, the Safe Food Coalition recommends filling inspector vacancies—currently at 40 percent—and reinstating the FDA inspector training program. FDA should increase the number of inspections of formula facilities,” the coalition says, “and fully fund the inspection program, including funding for state-level inspections,” the coalition said.
“According to the letter, the Administration should provide guidance to companies on proper testing and facilitate rapid product recalls by promptly sharing information with government law enforcement agencies. And the Administration should fully fund the chronically underfunded food safety work conducted within the CDC, including vital foodborne illness surveillance efforts such as FoodNet.”
The coalition's letter cited problems at the ByHeart infant formula plant, including signs of unsanitary conditions such as mold and insect infestation that were listed in FDA inspection reports. No follow-up action was taken. The coalition suggests that FDA staffing shortages have contributed to the problem.
“…with 40 percent of baby food and other 'critical food' inspector positions vacant, the FDA has limited ability to redirect inspection resources in response to unsanitary conditions like those observed at ByHeart. Cuts in 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 remaining inspectorate,” the coalition told health leaders in a letter.
The coalition says increased scrutiny of ByHeart's operations, including its Iowa manufacturing facility linked to the ongoing outbreak, may have led to earlier recalls and prevented illnesses.
“The nation's food safety system is on the brink of collapse,” said CSPI Regulatory Affairs Director Sarah Sorscher. “Forty percent of the personnel who inspect infant formula and other critical food products are not at their posts. This means the FDA has less flexibility in using its resources in response to outbreaks like the current ByHeart outbreak.”
Another coalition leader shared Sorscher's concerns.
“Contaminated infant formula puts the nation's most vulnerable consumers at risk and is an indictment of our food safety system as a whole,” said Thomas Gremillion, director of food policy for the Consumer Federation of America. “It's been more than three years since a Cronobacter outbreak linked to baby food caused shortages across the country, and we're seeing more inspector vacancies and fewer outbreak surveillance capabilities than ever.”
The Safe Food Coalition says President Trump's administration should work with Congress to establish adequate authority and funding to create effective protections against infant formula, citing several pieces of legislation pending in Congress.
Specifically, the coalition letter states that the FDA should announce Clostridium botulinum contamination is a hazard that requires preventative controls that producers should consider in their food safety plans. The Agency should develop recommendations for best practices to prevent Clostridium botulinum contamination based on an assessment of the root causes of the ongoing outbreak, and conduct a sampling program to test 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 heavy metals and nutritional adequacy. Finally, the FDA should offer guidance to companies on incorporating routine testing guidelines for the indicator organism Clostridium botulinum that were developed by the International Commission on Microbiological Food Specifications in 2014,” the coalition letter states.
The letter also addresses the failed recall of the contaminated ByHeart formula. The coalition says the FDA should investigate the root cause of the delays that have hampered the recall of ByHeart's formula, citing the fact that weeks after the recall was announced, the FDA reported that major retailers, including Walmart and Target, continued to sell the product.
“Notably, it reportedly took a lengthy process before the FDA agreed to disclose retailer names to state regulators, and this process can and should be streamlined not only for communications with recalls, but for all communications with state regulators,” the coalition said.
The consumer advocate group also called on HHS Secretary Kennedy to fully fund the Centers for Disease Control and Prevention, saying the agency's food safety program played a vital role in addressing the ByHeart outbreak. The coalition argues that the CDC's underfunding was recently reflected in cuts to the agency's FoodNet surveillance system, which was sharply cut from eight foodborne pathogens to 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 allocated to state and local agencies that form the backbone of oversight efforts.
“Identification of disease clusters leads to identification of outbreaks, which in turn leads to root cause analysis that informs good manufacturing practices, which in turn improves the safety of the food supply,” the coalition wrote to Kennedy and other food safety leaders. “However, without adequate funding, this feedback loop breaks down… The Administration should support a 50 percent increase in the CDC's food safety budget…”
Finally, the Safe Food Coalition called on Kennedy and two other food safety administrators to work with Congress to establish adequate authority and funding to create effective protections against infant formula. Bills that would help do this include:
o The Federal National Food Safety and Information Act, which would allow the FDA to share information with states in a timely manner to conduct recall audits;
o The Infant Formula Contamination Act, which requires companies to report positive test results on infant formula to the FDA;
o Enhancing the Safety of Food Testing and Infant Nutrition (INFENTS) Act, which would require additional product testing and environmental testing for infant formula, mandate reporting of positive product results, facilitate remote access to records, and provide additional recall authority; And
o The Baby Food Safety Act of 2024, which would require environmental monitoring at facilities that produce infant formula and baby food.
