FDA's New Reportable Food Registry Requirements

The Food and Drug Administration (FDA) recently launched its Reportable Food Registry (RFR) electronic portal. In conjunction with this launch, FDA has issued a final guidance further discussing the specific requirements.

The RFR requires responsible parties to file a report through the RFR electronic portal at http://rfr.fda.gov 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. Such foods are deemed by FDA to be “reportable foods.” A “responsible party” (defined below) must notify FDA of a reportable food within 24 hours of its discovery. These new reporting requirements apply to food and animal feed products. Infant formula and dietary supplement products are excluded.

FDA envisions that the new requirements will assist in faster responses to potential public health risks related to food. Notably, however, although the RFR requirements become effective on September 8, 2009, FDA has announced that it will exercise enforcement discretion until December 8, 2009.

Key RFR definitions and requirements are summarized below.

Please see full article below for more information.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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