When President Obama signed the Food Safety Modernization Act (FSMA) into law in 2011, it gave the FDA, for the first time, the power to order a recall of a food product determined to potentially present a danger to the public. Prior to FSMA, the FDA could only recommend that a manufacturer perform a voluntary recall of an adulterated or mislabeled product(s). In 2015 the FDA released a Draft Guidance offering an indication of how the Agency would apply this newly-granted authority. Industry stakeholders were encouraged to submit comments on the content of the Draft Guidance.
Despite possessing the ability to do so under FSMA, the FDA did not order the first mandatory recall of a product until April 2018, and then only after repeatedly requesting the manufacturer remove the products (suspected to be contaminated with Salmonella) from distribution.
Now, the FDA Center for Food Safety and Applied Nutrition (CFSAN) has issued a Final Guidance entitled, “Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff.” The Guidance provides the Agency’s current thinking on mandatory recall authority, offering an indication of when and how they will utilize the recall authority granted by FSMA. The document is in Q&A format and answers many of the questions submitted by industry stakeholders in response to the 2015 Draft version.
The document emphasizes that the FDA must provide a manufacturer an opportunity to voluntarily cease distribution and recall the food article when evidence of adulteration or misbranding exists. However, the Agency will act if it is determined the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.
In a corresponding press release, FDA Commissioner Scott Gottlieb, M.D. stated, “When issues arise that would put consumers at risk, we won’t hesitate to mandate the removal of a product from the market using the full extent of our authorities. It’s our responsibility. And it’s critical to our mission to ensure the safety of Americans.”
The Guidance provides information on when food will be considered adulterated or misbranded and thereby subject to a possible mandatory recall order and provides details on the process the FDA will follow when issuing a mandatory recall.
Furthermore, the FDA stipulates how they will publicize a mandatory recall order, “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 affected consumers and retailers. The publication will 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.”
This Guidance Document represents another step in the systematic implementation of FSMA and puts the food industry on notice that keeping the food supply safe is a fulltime endeavor and falling to do so will result in severe and expensive consequences.
For additional information on the Guidance Document Click Here