Federal regulators have told the infant formula industry that the contamination behind two U.S. botulism outbreaks and a global toxin event did not originate in the factories that packaged the formula. It arrived in the ingredients those factories bought.
In a letter to manufacturers, packagers, distributors, importers, and retailers, the FDA said it expects companies to exercise "substantive oversight of their suppliers," including understanding where ingredients come from, how they are produced, and whether the risks they carry are actually controlled.