Working with FDA During A Recall

By: Ashley Eisenbeiser, MS, CFS, Director, Food and Product Safety Programs, Food Marketing Institute

Food safety is the number one priority of the retail industry and maintaining food safety for customers requires diligence by the entire supply chain. Product recalls are the last step in the supply chain to remove potentially harmful products from commerce. There are endless reasons for product recalls, but no matter what, they are always highly stressful situations. The best way to handle recalls is to be prepared. During a recall, it is essential companies are prepared to communicate and work with their FDA District Recall Coordinator.

Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. Recalls are classified as Class I, Class II, or Class III. How recalls are classified depends on the hazard and the risk it poses to public health. Below are some examples of how a recall might be classified based on the hazard and the risk to public health.

	Examples
Class I Recall	Pathogens in ready-to-eat food: Salmonella, Listeria monocytogenes, E. coli O157:H7, Clostridium botulinum Allergens: milk, eggs, peanuts, tree nuts, crustacean shellfish, fish, soybeans
Class II Recall	Foreign objects that pose a physical hazard Pathogens: Shigella, Cryptosporidium Allergen: wheat FD&C colors: Yellow #5 or Yellow #6
Class III Recall	Filth Low levels of pesticide residue Misbranding (i.e., wrong product)

 

Recalls are initiated for a number of reasons, including a problem was identified by the firm, findings during a routine inspection, consumer complaints, etc. Most recalls are voluntary and most companies proactively take action. No matter what the situation is, when a company is involved in any way with a recall, they should always consult and involve the FDA District Recall Coordinators throughout the entire process. Doing so is essential to ensuring appropriate actions are taken to protect public health as well as:

• Developing and implementing a recall strategy
• Determining the recall scope and depth
• Monitoring the progress of the recall
• Providing the final recall classification

According to the 2017 U.S. Grocery Shopper Trends report, 76 percent of shoppers cite that they are more likely to shop at a store that is proactive and prompt in communicating recalls. The ability of retailers to quickly take action during a recall is something that is valued by customers; therefore, it is critical that you communicate and openly share information with your FDA District Recall Coordinator.

Earlier this month, FMI held a webinar with FDA on recalls. The webinar provided insight into FDA’s recall process for handling and classifying recalls, shared strategies for working with district recall coordinators, and discussed FDA’s current initiatives related to recalls. A recording of the webinar, along with the webinar slides, is available here.

Looking for more on recalls? Here are some resources that can help you ensure recalls are implemented in a timely and efficient manner.

• FMI Guidance for Retailers Product Recalls
• Managing the Risk of Food Recall to Keep Retailers Happy
• Top Food Recall Questions Answered
• Partnership for Food Safety Education Recall Basics