FDA’s Reportable Food Registry

Starting on September 8, 2009, the FDA’s Reportable Food Registry will become operational and responsible parties at the food establishments must comply with the requirements of the Registry as of that date. The Food and Drug Administration Amendments Act (FDAAA) of 2007 requires FDA to establish a Reportable Food Registry and an electronic portal through which responsible parties must submit instances of reportable food. The purpose of the Registry is to facilitate tracking of problems in the food supply, and to allow a more rapid response to such problems by FDA and the food industry

Section 417(a)(1) of the Federal Food, Drug, and Cosmetic Act (FDC Act) defines a "responsible party" as a person that submits the registration required under section 415(a) of FDC Act for a food facility at which the article of food is manufactured, processed, packed, or held.

Section 417(a)(2) of the FDC Act defines a "reportable food" as an article of food other than infant formula and dietary supplements for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals. 

On June 11, 2009, the FDA issued a draft guidance “Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007” concerning the Congressionally-mandated Reportable Food Registry.  When a responsible party becomes aware of a reportable food, it is to contact FDA within 24 hours.  Reports are to be filed electronically through the “Reportable Food electronic portal.” The initial report should include (1) the registration number of the responsible party; (2) the date the food was determined to be a “reportable food;” (3) quantity of food; (4) extent and nature of adulteration; (5) the results of any investigation undertaken by the responsible party to date; (6) the disposition of the food; and (7) the information typically found on the food’s packaging (i.e., product codes, use-by date, manufacturer/distributor). FDA may follow-up the initial report with additional questions or requests for more data and information concerning the product or the incident.

Reports to the Registry must be maintained by the responsible party for a minimum of two years.  Calling the FDA District Office or local health official does not relieve a responsible party from its obligation to report to the Registry.   

Section 417 of the FDC Act imposes substantial investigative, reporting, notification, and recordkeeping obligations on responsible parties.

To discuss the new obligations imposed on responsible parties and the effects that those obligations can be expected to have on existing practices, contact mdi Consultants, Inc at info@mdiconsultants.com and reference Food Reportable Registry.

If you need assistance with your Annual FDA Registration and Listing requirements you can contact mdi Consultants at info@mdiconsultants.com and reference Reg/List for 2010.