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FDA Issues Draft Guidance on Mandatory Food Recalls

May 07, 2015

The Food and Drug Administration yesterday issued draft guidance for industry on mandatory food recalls that is available for public comment. The draft guidance is in the form of questions and answers that focus on common questions that might arise about how FDA will use this mandatory recall authority, including:

  • What foods are subject to FDA’s mandatory food recall authority?
  • What are the criteria for a mandatory recall? 
  • What is the process FDA must follow for a mandatory recall?

FDA has the authority to order a “responsible party” to recall a food if the company refuses to recall product voluntarily and there is reasonable probability that the food (other than infant formula, for which FDA has separate recall authority) is adulterated or misbranded under certain provisions of the Federal Food, Drug, and Cosmetic Act, and that the use of or exposure to that food will cause serious adverse health consequences or death, which is the standard for a Class I recall.

The authority for mandatory food recalls was provided by the FDA Food Safety Modernization Act and became effective immediately when President Obama signed the Act into law in January 2011. Congress aimed to better protect public health by providing FDA with more effective enforcement tools.

FDA will consider all comments received during the 60-day comment period before completing a final version of the guidance.

Members also may be interested in IDFA’s new webinar, “Recall Preparedness: What to Do When Things Go Wrong,” on June 10, 2:00 – 3:30 p.m. Eastern time. Learn more and register here.

For more information about the guidance or the webinar, contact John Allan, IDFA vice president of regulatory affairs and international standards, at

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