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Article: FDA policy nebulous in reportable food registry guidance.(WASHINGTON)
- Article from:
- The Food Institute Report
- Article date:
- October 19, 2009
CopyrightCOPYRIGHT 2009 The Food Institute. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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On Sept. 8, FDA issued a guidance document on the Reportable Food Registry (RFR): Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (available at http://www.fda.gov/Food/ Guidance ComplianceRegulatoryInformation/GuidanceDocuments/FoodS afety/ucm180761.htm)
The Guidance details how FDA intends to implement the new reporting requirement set forth in Section 417 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under Section 417, a "responsible party" must submit a report to FDA within 24 hours after the responsible party determines that any food it has ...