Representative Rosa Delauro (D-CT03) has introduced the Infant Formula Safety Modernization Act into Congress in the wake of the ByHeart formula botulism outbreak. The Act is intended to close gaps in testing, transparency, and regulatory enforcement.
In that outbreak, at least 48 infants were sickened with a botulism infection. All were hospitalized and all were treated with BabyBIG®, the FDA-approved treatment for this infection that was developed by the California Department of Health.
And in 2022, Abbott Nutrition’s facility in Sturgis, Michigan shut down after a Cronobacter outbreak. A huge recall of Abbott’s products triggered a shortage of infant formula in the United States.
DeLauro said in a statement, ““The food we give our babies must meet the highest standard of safety — no exceptions. For too long, a resource-starved FDA has lacked the tools to adequately protect the infant formula supply. The recent ByHeart outbreak, which contaminated formula with Clostridium botulinum and sickened dozens of infants across the country, has further exemplified gaps in infant formula safety that are impossible to ignore. This legislation fixes that.”
The Act accomplish six things that will hopefully help keep the formula safer. First, expanded pathogen testing will be required, adding Clostridium botulinum to the list. Second, environmental testing in facilities will be mandated. This should help detect contamination in the production environment before it reaches wthe product.
Third, consistent testing standards will be set. Rather than each company setting their own standards, manufacturers will be required to follow uniform FDA-set standards. Fourth, manufacturers will be required to notify the FDA of any positive pathogen test, even if the formula has not been distributed. At this time, companies are not required to tell the FDA about the contamination until the formula has entered the marketplace.
Fifth, foreign manufacturers will be held to the same new standards as American manufacturers. And finally, Congressional oversight will be strengthened, requiring that Congress is informed of any confirmed positive pathogen test in finished infant formula.
DeLauro added, “Multiple crises year after year make clear that the current system is not working. My Infant Formula Safety Modernization Act closes critical gaps to prevent the next outbreak before it occurs.”
