Facilities that manufacture, process or hold food for consumption in the US now must tell FDA within 24 hours if they find a reasonable probability that an article of food will cause severe health problems to a person or animal.

The reporting requirement applies to all foods and animal feed regulated by FDA, except infant formula and dietary supplements, which are covered by other regulatory requirements. Some examples of why a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.