Food Facilities Now Required to Report Potentially Dangerous Products

With today’s opening of FDA’s electronic Reportable Food Registry (RFR) portal, food industry officials are now required to alert FDA when they find their products might sicken or kill people or animals. The requirement, a result of legislation, took effect with the launch of the portal.

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

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

The requirements apply to any person who has to submit registration information to the FDA for a food facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States. This responsible party must investigate the cause of the adulteration if the adulteration of food may have originated with the responsible party; submit initial information, followed by supplemental reports; and work with FDA authorities to follow up as needed.

A filed report will need include information on the type of report being submitted; the fFood facility registration number for the responsible party site; the location of reportable food with contact information;  the problem origination site; the product problem (how and when it was discovered, information about the suspect products, and a description of the problem); and an option for attaching supplemental information.

Once the report is filed, FDA will issue an Individual Case Safety Report (ICSR) number, which will then be used for submitting amended reports and providing notifications.

A report is not required if the problem is found and corrected before the food is shipped or the food is destroyed.

Further information and RFR Guidance is available at FDA.gov.