On September 8, 2009, the reporting requirements of the Reportable Food Registry (section 417 of the Food Drug and Cosmetic Act) will become effective. Companies registered with the FDA should make themselves current on their reporting obligations.
Those companies required to report are called “responsible parties” and are those facilities which previously registered under the Act (i.e., facilities engaged in the manufacturing, processing and holding of food for consumption in the U.S.).
A “reportable food” is an article of food “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 of humans or animals.” The criteria for reporting to the Registry is approximate to that level of concern comparable to classification of a Class 1 recall. Otherwise, “food” includes the standard definition of “(1) articles used for food or drink for man or other animals (other than infant formula), (2) chewing gum and (3) articles used for components of any such article.”
The FDA has issued the draft guidance, “Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of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.” This article highlights sections of the Guidance and, although the Guidance represents FDA’s “current thinking,” it does not “create or confer any rights” and “does not operate to bind FDA.” It should be reviewed by all companies who are registered with FDA (see: 74Federal Register27804, 06/11/2009).
The emphasis of the notification process is on identification and investigation of potential for more serious health consequences, as a report to the Registry is not/shall not be considered an admission that the reported food or incident constitutes adulteration, or in any way contributed to any adverse health consequences, illness or death. The report “may be accompanied by a statement, which shall be part of any report that is released for public disclosure that denies that the report or notification constitutes an admission that the product involved caused or contributed to a death, serious injury or serious illness.”
When a responsible party becomes aware of a reportable food, it is to contact FDA within 24 hours. A report to the Registry need not be made, if the concern or adulteration originates with the responsible partyandthe potential adulteration was detected prior to distributionandthe responsible party has corrected the concern. The FDA will then assign a number to the report and will follow up with the responsible party for additional and background information.
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.
Companies registered with the Food and Drug Administration are encouraged to review the Draft Guidance and to be prepared to comply by the September 8, 2009, deadline. pf