FDA Offers Guidance for Mandatory Food Recalls
The U.S. Food and Drug Administration (FDA) recently issued guidance to the “industry” and FDA staff as to mandatory food recalls and providing integral information on how to handle and/or implement such food recalls when necessary.
This guidance expands upon the FDA’s mandatory food recall authority that was first enacted under Section 423 of the Federal Food, Drug and Cosmetic Act (FD&C Act), which was added by Section 206 of the FDA Food Safety Modernization Act of 2011 (FSMA). The FDA’s mandatory food recall authority went into effect when FSMA was enacted on January 4, 2011. Before FSMA was enacted, the FDA relied primarily on the manufacturers to voluntarily recall the food products at issue. The guidance further outlines that the types of foods that are subject to the mandatory recall include all foods (other than infant formula, which has its own recall authority) that are manufactured, processed, packed, or held at a food facility that is required to be registered under the FD&C Act.
While the FDA continues to rely upon manufacturers to voluntarily recall certain products, the FDA now has authority to mandate a recall if they deem one necessary.
However, before implementing a mandatory recall, the FDA must determine that (1) there is a reasonable probability that the article of food is adulterated or misbranded and (2) that the use of or exposure to such food will cause serious adverse health consequences or death to humans or animals.
The FDA advised that, in consideration of instituting a mandatory food recall, all applicable evidence will be evaluated. Some examples may include:
- Food safety observations;
- Results from sample analyses;
- Epidemiological data;
- Vulnerability of the population that normally consumes the product at issue;
- Nature of the food product;
- Reportable food registry data,
- Consumer and trade complaints; and
- Whether responsible party failed to initial voluntary recall.
Finally, this guidance advises during a mandatory food recall, the FDA will ensure that a press release is published regarding the recall, as well as alerts and public notices, as appropriate, to provide notification to potentially affected consumers and retailers. Specifically, this publication would include, at a minimum, “the name of the article of food subject to recall, a description of the risks associated with the food, and to the extent practical, information about similar articles of food that are not affected by the recall”.
As the FDA continues to monitor and place emphasis on food safety issues, this guidance will prove to be an important tool in understanding if, when and how the FDA will implement mandatory food recalls. Consequently, from the perspective of potential future litigation, all parties should be aware of the FDA’s position and this guidance.
A copy of the FDA’s Guidance Document can be found here.