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FDA Health Hazard Evaluation Procedures

The Food and Drug Administration (FDA) is responsible for keeping the American public safe from any illnesses or diseases that may result from a contaminated food source, among other duties. When a product is suspected to be contaminated, the FDA will frequently recall the product; however, there are procedures that must be addressed before a recall can take place.

  1. Recalls

    • A recall is assigned when a product is in violation of FDA laws or regulations and is the most effective way to remove or correct a potentially harmful product from the reach of the public. A recall may be issued by the FDA or can be voluntarily issued by the manufacturer or distributor. Part of a recall is a public warning, in which the FDA releases a statement warning the public of possible adverse side effects from the use of the recalled product.

    Evaluation

    • Before a product can be recalled, a group of scientists from the FDA evaluate the contaminated food or product and consider the following questions: Have any illnesses or injury resulted from the use of the product? Are there existing conditions that could have contributed to a situation that would expose animals or people to a health hazard? What population is most affected by this hazard? How serious is the health hazard? How likely will illness be the result of this hazard? Are the consequences from this hazard short or long term? Based on the answers to these questions, the FDA scientists will assign the recall to a class according to the severity of the hazard.

    Classes

    • Recalled products may be assigned to one of three classes: Class I, Class II or Class III. A Class I recall is appropriate for a reasonable probability that exposure to or use of a product will end in serious health complications or death. Class II recalls are for situations where the use of or exposure to a product may cause temporary or medically reversible health complications, or where the probability of serious health complications is remote. Situations that are not likely to end in adverse health issues are Class III recalls.

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