11/14/2025 | Press release | Distributed by Public on 11/14/2025 16:46
Today, US Representative Rosa DeLauro released a letter she wrote to FDA Commissioner Marty Makary requesting the Food and Drug Administration facility inspection records for ByHeart, following reporting that the company's infant formula was linked to an infant botulism outbreak:
"There must never be a question in parents' minds that the formula they give to their children is safe. The New York Times'reporting about a botulism outbreak linked to ByHeart's formula, along with alarming details of safety and hygiene violations at a separate ByHeart facility, is deeply alarming and I am requesting all available information about this company's practices.
"FDA plays a vital role in protecting our nation's food supply, yet once again these safety violations were revealed to the nation by reporters, not our public watchdog. As the Chair of the Food Safety Caucus, I will continue to press FDA for answers and transparency about its investigation practices. There is no excuse for inaction when children's safety is on the line."
Full text of the letter is available here.