FDA Delays Implementation of Reportable Food Registry, Announces Draft Guidance

The Food & Drug Administration (FDA) today (June 11, 2009) delayed implementation of the Reportable Food Registry requirements of section 417 of the Food and Drug Administration Amendments Act of 2007, Public  Law 110-85 (FDAAA) to September 8, 2009. It simultaneously announced the availability of a draft guidance entitled “Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007” (the “Guidance”).

On September 27, 2007, the President Bush signed FDAAA into law. Among other things, Section 1005 of FDAAA amends the Federal Food, Drug, and Cosmetic Act (the “Act”) to include a requirement that the Secretary of Health and Human Services to establish within FDA a Reportable Food Registry (the Registry) by September 27, 2008 under new Act § 417, 21 U.S.C. 350f.   To further the development of the Registry, the Act also requires FDA to establish a reportable food electronic portal for responsible parties and public health officials to use to submit to the FDA instances of reportable food by September 27, 2008.  The draft Guidance, when finalized, will assist the industry in complying with these Reportable Food Registry requirements.

Read the Federal Register notice here.

For More Information

We hope that this information is useful to you. If you need assistance with auditing or defending health care fraud concerns or other health care compliance, risk management, transactions or operations concerns, please contact Cynthia Marcotte Stamer at (214) 270-2402, CStamer@CTTLegal.com.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information to CStamer@CTTLegal.com.

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