Since the fall 2023, the United States has been facing a massive recall of apple cinnamon fruit purees (like apple sauce) due to the presence of elevated levels of lead which caused the product to be considered adulterated under the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”).
As a part of the market removal process, retailers were instructed to remove the contaminated product from shelves. However, months after the recall, the Food and Drug Administration (the “FDA”) found through recall audit checks (RACs) that the recalled products remained on the shelves of the retailer’s stores – potentially available for sale and human consumption.
According to a June 11, 2024 Warning Letter issued by FDA, the retail chain failed to provide adequate assurances that the recalled puree products were pulled and destroyed, as demonstrated by the product remaining on shelves for long after the recall was initiated. Although steps were taken by the retailer to prevent the sale of recalled products, anything less than complete removal and destruction is insufficient in the eyes of the FDA. For example, the retailer blocked the UPC from being able to be scanned at checkout, preventing the sale of the product. However, the FDA found this inadequate as the product was still available for individuals to remove from the shelf and consume in store, as one child did in the state of Washington.
While retailers like grocery stores are primarily regulated by state and local agencies, the long arm of the FDA must be respected and plays an important role in regulating retailers that sell food products to consumers. Receiving or delivering adulterated food through interstate commerce is a violation of the FD&C Act which can carry legal penalties. Since most food retailers receive and sell products sourced from all over the country or even the world, the retailers are subject to FDA regulation.
The FDA’s response to this retailer’s failure demonstrates that the FDA does not take recall response lightly and has high expectations for all levels of the supply chain. Retailers should have comprehensive recall response plans in place so that they can efficiently and effectively engage during a product recall. Additionally, if a failure does occur, retailers should be prepared to create forward-looking corrective action plans that improve upon their systems to prevent future incidences. While the FDA’s regulatory emphasis may still be focused on food manufacturers, retailers will not escape consequences if they fail to take appropriate steps to remove and destroy recalled products. The FDA’s action stresses the importance of retailers within a recall as it potentially adulterated products.
The FDA offers guidance and recommendations to food retailers for best practices to keep food safe and free from adulterants as well as general industry guidance for recalls of any FDA-regulated products.
A good recall plan for a retailer will include various elements such as:
- Immediate Action:
- Remove Affected Products: Quickly remove all recalled products from shelves and storage areas.
- Isolate and Label: Clearly label and isolate recalled products to prevent accidental sale or use.
- Follow Instructions: The recalling firm will provide specific instructions for the disposal of the product. This should be followed especially if return of the product is requested.
- Communication:
- Notify Staff: Inform all employees about the recall and provide instructions on handling the affected products.
- Customer Notification: Consider using various channels (email, social media, in-store signage) to inform customers about the recall and the steps they should take.
- Supplier Coordination: Stay in close contact with suppliers to get the latest updates and instructions regarding the recall.
- Documentation and Tracking:
- Record Keeping: Maintain detailed records of the recalled products, including quantities, lot numbers, other important identifying information, cost of recall actions and customer refunds, and replacement costs.
- Tracking Sales: Track which customers purchased the recalled products, if possible, to facilitate direct communication.
- Customer Service:
- Return and Refund Policy: Clearly communicate the return and refund process for recalled products to customers.
- Support Channels: Set up dedicated support channels (hotline, email, in-store help desk) to address customer concerns and questions.
- Compliance and Reporting:
- Regulatory Compliance: Ensure all actions comply with local, state, and federal regulations regarding food recalls.
- Report to Authorities: Respond to in a timely fashion any communications from relevant health and safety authorities.
- Training and Preparedness:
- Employee Training: Regularly train employees on recall procedures and food safety practices.
- Mock Recalls: Conduct periodic mock recalls to ensure readiness and efficiency in handling real recalls.
- Post-Recall Actions:
- Analyze and Improve: After the recall, analyze the response to identify areas for improvement.
- Restock Safely: Ensure all restocked products are safe and unaffected by the recall before placing them back on shelves.
Food retailers may benefit from ensuring that their recall plans and procedures are up to date and reflect current technologies and capabilities. If food retailers or manufacturers are unsure whether they are meeting food safety legal requirements, contact Emily Lyons or your Husch Blackwell attorney for more information.
Written with the assistance of Vanessa Villasenor, a summer associate in the Minneapolis, Minnesota office.