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Mandatory Food Recalls

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FDA Mandatory Food Recalls

The mandatory food recall authority went into effect when the FDA Food Safety Modernization Act (FSMA) was enacted on January 4, 2011.

The agency can since then, order a responsible party to recall an article of food where the FDA determines that there is a reasonable probability that the product (other than infant formula), is adulterated or misbranded, and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals (SAHCODHA).

Food products (other than infant formula) must be  manufactured, processed, packed, or held at a food facility that is required to register. Infant formula is not covered because it has its own recall requirements. The term “food” here, includes dietary supplements.

Owners, operators, or agents in charge of a facility and its registration, are also responsible for implementing and assuring the recall is performed, if so ordered.

Once the FDA has determined that the criteria for a mandatory recall have been met, the agency must first provide an opportunity to voluntarily cease distribution and recall the article of food.

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FDA Process for a Mandatory Recall

Once the FDA has determined that the criteria for a mandatory recall have been met, the responsible party will be notified in writing using an expeditious method of delivery.

If the responsible party refuses or does not voluntarily cease distribution and recall the article of food within the time and manner prescribed, the FDA may order the responsible party to cease distributing the article of food, order the responsible party to give notice to certain other persons to cease distributing the article of food, and give the responsible party an opportunity to request an informal hearing to be held not later than 2 days after the issuance of the order.

Following these steps, the FDA Commissioner may order a recall taking into account:

  • Significant food safety observations made during establishment inspections
  • Results from sample analyses, which may include those for raw materials or finished food products, and certain sample swabs from the food facility manufacturing environment
  • Epidemiological data (food borne outbreak data directly related to the food product that suggest disease or injuries have already occurred from the consumption of/exposure to the product)
  • Vulnerability of the population that normally consumes or is exposed to the food product (infants, toddlers, the elderly, pregnant women, medically compromised individuals, certain pets, young livestock)
  • Nature of the food product (Ready-to-eat food, raw, cooked)
  • Reportable Food Registry data
  • Consumer and trade complaints
  • Whether the responsible party has failed to initiate a voluntary recall.

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