FDA Delays Implementation of FDAAA Reportable Food Registry until 2009May 28, 2008
As we previously reported, the Food and Drug Administration Amendment Act of 2007 (“FDAAA”) mandates that FDA create a Reportable Food Registry (“Registry”). 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. Under new FDC Act § 417, a responsible party must report to FDA the occurrence of a “reportable food,” i.e., a “food . . . for which there is a reasonable probability that the use of, or exposure to, such . . . food will cause serious health consequences or death to humans or animals.” The failure to submit a report is a prohibited act under FDC Act § 301(mm).
Although FDAAA requires that FDA create the Registry by Sept. 27, 2008 and that the Agency issue guidance concerning use of the Registry no later than June 27, 2008. FDAAA § 1005(e), (f), FDA announced on May 27, 2008 that implementation of the Registry will be delayed. According to the Agency, because “FDA intends to [use] the business enterprise system,” a system that is under development and will not be operational before Spring 2009, implementation of the Registry will be delayed until at least early 2009. Meanwhile, FDA requests comments concerning the Registry provision in FDAAA. Specifically FDA asks for comment on:
- “What obstacles, if any, . . . responsible parties anticipate in complying with the requirements of [FDC Act § 417]?”
- Suggestions concerning ways to “enhance the quality, utility, and clarity of the information to be submitted to the Registry.”
- Suggestions for “an efficient and effective method for providing and receiving notifications” about a reportable food.
- Whether, in addition to the eleven data elements currently required in a report submitted to FDA, “other information, if any, would be important” in “notifications to the immediate previous source and immediate subsequent recipient of the [reportable] food.”
The deadline for written comments is August 11, 2008.