The Food and Drug Administration (FDA) this week released the Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2). The congressionally identified purpose of the reportable food registry is to provide a "reliable mechanism to track patterns of adulteration in food, which would support efforts by the FDA to target limited inspection resources to protect the public health."
This guidance document contains questions and answers relating to the requirements under the act, including how, when and where to submit reports to FDA; who is required to submit reports to FDA; what is required to be submitted to FDA; and what may be required when providing notifications to other persons in the supply chain of an article of food.
The guidance draft is available at
FDA's guidance documents do not establish legally enforceable responsibilities. Instead, it describes the agency's current thinking on a topic and should be viewed as recommendations, unless specific regulatory or statutory requirements are cited.
Comments can be submitted at www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that published in the May 25 Federal Register available at http://edocket.access.gpo.gov/2010/2010-12456.htm.