On September 8, FDA issued Final Guidance for Industry providing questions and answers on compliance with the Reportable Food Registry requirements. Reports must be submitted, effective immediately, to the Reportable Food Report at http://rfr.fda.gov/ by registered food facilities that manufacture, process, pack or hold food for human or animal consumption in the United States under section 415(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350d). Registered facilities are required to report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. FDA states in its Final Guidance that it will exercise its enforcement discretion for the first 90 days (i.e., until December 8, 2009) in circumstances where FDA determines that the registered facility has "made a reasonable effort to comply with the requirements of section 417 of the FD&C Act," which covers the Reportable Food Registry. Companies would be well-advised to develop and promptly implement procedures for reviewing customer complaints for reporting under these criteria and readily reporting events within the prescribed time frames (i.e., within 24 hours of determining that a food is a reportable food).