WASHINGTON, D.C. — The Food and Drug Administration linked ByHeart's infant formula to cases of infant botulism after detecting Clostridium botulinum in its products. FDA investigators matched Clostridium botulinum isolates from organic whole milk powder supplied to ByHeart with samples from sealed formula cans and infected infants.

Katie Connolly's daughter developed infant botulism last year after consuming contaminated infant formula from ByHeart. "You buy a product that you think is going to be safe for them, and it ends up putting them in the hospital," Katie Connolly said. No deaths have been reported in connection with the Nara Organics or ByHeart infant botulism cases.

The organic whole milk powder supplied to ByHeart was produced by Organic West Milk and processed at a Dairy Farmers of America facility. While infant botulism can cause progressive paralysis, potentially leaving infants unable to breathe, current regulations do not require infant formula manufacturers to test for Clostridium botulinum. Manufacturers must undergo annual FDA inspections and test for salmonella and Cronobacter.

"Nara and ByHeart were both manufacturers claiming to produce a healthier type of infant formula because they were using whole milk," said Frank Yiannas, former deputy commissioner for food policy and response at the FDA. ByHeart markets its products with references to ingredient sourcing and a patented protein blend formulated to resemble breast milk. The FDA also linked the Nara Organics infant formula brand to three recent cases of infant botulism.

U.S. regulations require infant formulas to contain a specific blend of 30 ingredients. FDA officials stated that understanding the risks associated with Clostridium botulinum in infant formula is a priority for the agency.