This bill strengthens safety requirements for infant formula by requiring manufacturers to test their products and facilities for dangerous bacteria and pathogens. Right now, infant formula companies follow general manufacturing rules, but this bill creates specific, standardized testing requirements that all manufacturers must follow—whether they're domestic or foreign. Companies would need to test for harmful pathogens like botulism bacteria in both their finished formula and their manufacturing facilities, including areas that don't directly touch the formula but could still contaminate it. If a manufacturer finds a positive test result, they must notify the FDA within one business day, even if the contaminated formula hasn't left their facility yet. The FDA would then immediately notify Congress about any positive tests or serious inspection failures. This creates a faster, more transparent system where problems are caught and reported quickly, giving regulators and lawmakers real-time visibility into potential safety issues. The goal is to prevent contaminated formula from reaching babies and to catch problems at the manufacturing stage before products are distributed.

To amend the Federal Food, Drug, and Cosmetic Act to establish standardized pathogen and microorganism testing of infant formula products and manufacturing facilities, to mandate notification of specific positive tests and inspection classifications, and for other purposes.