FDA's Reportable Food Registry: Enforcement, Exceptions and Future Rulemaking

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Stoel Rives food liability attorney Ken Odza reviews in Food Chemical News four key question regarding the Food and Drug Administration's ("FDA") Reportable Food Registry ("RFR"). The RFR was created by Congress as a part of the Food and Drug Administration Amendments Act of 2007 and is codified at 21 U.S.C. §350f. The RFR requires that "as soon as practicable, but in no case later than 24 hours after a responsible party determines that an article of food is a reportable food, the responsible party shall (a) submit a report to [FDA] … and (b) investigate the cause of the adulteration if the adulteration of the article or food may have originated with the responsible party." Reportable food is adulterated food that has the "reasonable probability" of causing "adverse health consequences or death."

Odza said that four key questions remain for the food industry with regard to how and if the FDA will:

  1. use the RFR as an enforcement tool;
  2. move toward the concept of "control" and away from "possession" in interpreting one of the key exceptions to the RFR;
  3. address what it perceives as "out of control" undeclared allergen problems; and
  4. use the information obtained through the RFR to shape coming regulations on required preventative controls.

Following his discussion of these four questions, Odza suggests that to help mitigate the risk of FDA enforcement actions, product liability claims, supply chain contract claims and recalls, food manufacturers should anticipate FDA's eventual rule making and update or create food safety plans that address the hazard analysis and preventative of the Food Safety Modernization Act recently passed by Congress. One way to anticipate FDA's direction on this, he adds, is to mine the information FDA has collected and continues to collect as part of the RFR.

You can read Odza's article on the Food Chemical News website (registration required).

"The FDA's Reportable Food Registry: Four Burning Questions" was published by Food Chemical News, April 29, 2011.

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