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FDA Urged to Make Changes to its Food Recall Activities
Tuesday, April 26, 2022
  • The Association of Food and Drug Officials (AFDO)— a nonprofit organization made up of regulators, industry representatives, and other stakeholders— released a white paper in which it outlined problems in FDA’s recall activities and proposed solutions to the identified issues.

  • The report identified two broad ongoing problems effecting FDA regulated food product recalls: (1) consumers continue to get sick after the issuance of a recall announcement and (2) the recall is typically issued and communicated too late to prevent additional illness. The report details each stage of the food recall process as well as specific issues that were identified at each step including:

    • Lack of consistency on how and when a recall is triggered;

    • Long delays and misclassification of recalls;

    • Lack of urgency in notifying states of pending recalls;

    • Lack of training on what to expect from regulators during a recall;

    • Lack of adherence to timeframes for assigning recall audit checks;

    • Lack of communication between state authorities and FDA; and

    • Lack of clear lessons learned after recall termination.

  • To rectify these problems, AFDO recommends that FDA make changes to:

    • Policy, including creating clear timelines for recall classification, hazard analysis, alerts to state partners, and issuance of recall audit checks.

    • Training, including increased training on recall activities for both industry and regulators.

    • Communication, including improved communications between all stakeholders, and leveraging artificial intelligence and other technology-based solutions.

    • Recall Management, including streamlining recall decisions by rethinking FDA’s organization structure and measuring if existing timeframes are being met.

    • Culture, including creation of a culture in which recalls are treated as public health emergencies and changing federal statutes to allow for more free distribution of information.

  • We will monitor and report on any changes that FDA makes to its recall policies and procedures.

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