The Food and Drug Administration last Tuesday released revised and expanded guidance for its new Reportable Food Registry. Although the registry became effective the same day, FDA intends to exercise enforcement discretion for 90 days for companies that have made "a reasonable effort" to comply. This period will end December 8.
A reportable food is any food product or ingredient for which there is a reasonable probability that the use of or exposure to the product will cause serious harm or death to humans or animals. With the new registry, companies will be required to file within 24 hours of the company making a determination that the food product has a reasonable probability of presenting this kind of risk.
One of the more controversial points in the new guidance relates to the concept of transferring products and its impact on a determination of whether or not to report. Companies will not be required to submit a report if the adulteration originated at the company, it was discovered before being transferred and it was corrected or destroyed. However, if companies find that they have transferred an adulterated food product to other persons, they will be obligated to report. In addition, once a product leaves the company's possession and has tested positive for the presence of a pathogen, it must be reported, even if subsequent testing turns out to be negative.
IDFA does not agree with FDA's interpretation of the transfer concept and plans to work with FDA to clarify it. In comments filed last month, IDFA claimed that as long as a company retains control of the product, the product should not be considered transferred.
Detlefsen said there will be serious penalties for underreporting, especially after December 8. Violation is considered a prohibited act, which can include monetary penalties and jail time.
In addition to the guidance, FDA released an appendix with detailed instructions for completing the registry report and a list of frequently asked questions that deals with technical issues.
For more information, contact Detlefsen at firstname.lastname@example.org or (202) 220-3554.
• Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007