Leaders at the US Food and Drug Administration have issued a new call to action to the infant formula industry to protect babies from illnesses caused by Salmonella and Cronobacter sakazakii bacteria.
“This letter is intended to assist industry in improving the microbiological safety of powdered infant formula,” FDA Commissioner Dr. Robert Califf and Susan Mayne, the director of the Center for Food Safety and Applied Nutrition, wrote in the letter Wednesday.
The FDA urged compliance with formula requirements and regulations throughout the production process and with the notification process for when a contaminated or mislabeled formula leaves a facility. The agency also asked that companies notify the FDA when a formula product tests positive for Salmonella or Cronobacter.
The letter highlighted specific issues that need improvement at manufacturing facilities, such as reducing the amount of water in dry production areas, testing for harmful bacteria on environmental surfaces and ensuring that raw ingredients used in formulas are safe.
Facilities also need a corrective plan when pathogens such as Salmonella or Cronobacter are found in the environment or in the product, the FDA said.
The FDA’s food safety staff has met with powdered infant formula manufacturers “regularly” over the past two months, the agency said in a news release Wednesday.
“These meetings have allowed for a meaningful dialogue with manufacturers about their current food safety practices, including practices the FDA has observed during inspections, and opportunities for improvements,” it said.
But critics of the FDA say the areas of concern outlined in the letter are “basic food safety concepts.”
“The FDA is responsible for fulfilling its public health mission of ensuring all consumers are protected from foodborne illness. It is unfortunate infants had to get sick and die in order for the FDA to request companies to ‘ensure full compliance with all relevant regulations,’ ” said Mitzi Baum, CEO of the advocacy group Stop Foodborne Illness.
Most cases of Cronobacter infection are treatable with antibiotics, but the infection can lead to meningitis, sepsis and other devastating complications such as permanent brain damage. Last week, a report from the US Centers for Disease Control and Prevention warned that infections from Cronobacter sakazakii can come from improper sanitation of breast pump equipment and a lack of safe storage and preparation of powdered infant formula at home.
Cronobacter bacteria was also at the center of the nationwide infant formula shortage last year.
Multiple popular brands of powdered formula were recalled and production at a major manufacturing plant was halted after the FDA received reports of four infections, including two deaths, among infants who had consumed formula from the Abbott Nutrition facility. An FDA investigation detected Cronobacter bacteria in the plant, but genetic testing couldn’t link that bacteria to the sick infants.
Since then, other brands of formula have been recalled due to bacteria risk, including 145,000 cans of Enfamil formula.
In January, the FDA proposed changes to its Human Foods Program, including new structures that would be led by a single director who would oversee food safety, policy and some regulatory duties and create a new center focused on nutrition.
However, a group of key stakeholders from consumer organizations and food industry leaders criticized the FDA’s announcement, saying it indicated a continuation of “matrix management,” limiting any efficient decisions a new deputy commissioner could make.
Califf is “choosing business as usual instead of the bold changes we’ve adamantly advocated for that would transform the Foods Program from one of inaction and indecision to one of action,” Roberta Wagner, vice president of regulatory and technical affairs at the Consumer Brands Association and former FDA official, said at the time.