FDA Issues Draft Guidance on Food Recalls

Misbranding Recalls lowU.S. Food and Drug Administration is seeking comments on a new draft of guidance regarding food recalls. The mandatory food recall authority is part of the Food Safety Modernization Act which was enacted in January of 2011.

Prior to the FSMA, there was no mandated requirements for responsible parties to recall violative food products. Most recalls were voluntarily provided by the food industry. Under the current rule, the FDA and responsible parties are given authority to mandate a recall under the circumstance that there is reasonable probability that the products have been adulterated or misbranded.

A responsible party is defined as a person who submits the registration for a food facility at which the food is manufactured, processed, packed or held. “As such, the owner, operator or agent in charge of a facility who is responsible for submitting the registration is also responsible for implementing and assuring the recall is performed.”

According to the guidance, FDA will issue recalls based on the following evidence:

  • Observations made during inspections of the responsible party or other parties;
  • Results from sample analyses;
  • Epidemiological data;
  • Reportable Food Registry data; and
  • Consumer and trade complaints.

The FDA claims the use of recall authority will be rare. Companies will be given a hearing before recalls are issued. Read the food recall mandate drafted guidance here. Please issue any comments to IWLA at gac@IWLA.com.

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