Did you know that more foods were recalled due to labeling errors than pathogenic contamination during the last quarter? Based on a recent quarterly finding from Stericycle ExpertRECALL, Food Safety News reported that 60 percent of all FDA-monitored food recalls during the second quarter of 2013 were due to undeclared allergens on food labels. This finding is a wake-up call for all food manufacturers, distributors, and marketers to tighten their manufacturing practices and specification protocols; it shows that FDA has put this as a high priority during food facility inspections.
The law requires that the labels for all foods that are, or contain protein from, a “major food allergen” identify clearly and specifically the name of the protein source from which the allergen is derived on their labels. The key 8 allergens are wheat, crustacean shellfish, eggs, fish, peanuts, milk, tree nuts and soybeans, which together compose 90 percent of all food allergies in the United States. The purpose of this labeling requirement is to protect consumers from using food products that may cause allergic reactions. Consumers typically rely on the information on food labels to tell them what foods they should avoid.
A food product may be subjected to a recall if it contains any major food allergen and its label fails to properly declare the presence of the allergen. Food recalls due to undeclared allergens typically happen after FDA conducts a facility inspection or samples the food at the border (during the importation process). Sometimes states conduct retail shelf sampling and testing to determine if food contains undeclared allergens.
Errors related to food allergen labeling are generally due to poor manufacturing controls and procedures. These problems may be caused by a manufacturer’s negligence in verifying the ingredients used in the product against the label or by using the wrong ingredients during processing. Sometimes companies make the mistake of simply relying on their suppliers’ assurances or declarations, which may be incorrect or inadequate to highlight the presence of an allergenic protein. Under the new Food Safety Modernization Act (FSMA), major food allergen labeling is handled like a food safety adulteration problem. This is a unique labeling requirement that often leads FDA to act as a strong food safety enforcement agency, chasing the food through the supply chain and looking for the company responsible for the error. As FDA begins to implement more provisions of FSMA, more recalls are likely to follow.
However, simple verification steps could be built into existing procedures to reduce the risk that food a company imports or distributes will lack the required allergen declarations. Companies all along the supply chain can develop adequate Allergen Control Programs to ensure reviews of the product and label at key times in a food product’s life cycle. This is especially important, for instance, when there is a change in a product formula or raw material supplier.
A simple mistake – not declaring major food allergens properly – can cost companies a fortune! At worst, this issue will result in an FDA-monitored recall. Depending upon the facts, FDA could order a mandatory recall, if the companies in the supply chain delay in responding. The company’s public image can be damaged by the recall or a following FDA Warning Letter, inviting civil lawsuits against the company. It is critical for food companies to ensure that their product labels correctly declare allergens before bringing the product to market. The FDAImports.com consultants are here to provide your company with guidance to ensure compliance with the food allergen labeling requirements, as well as reviewing all other important regulatory aspects of food labeling, manufacturing and importing. Contact us today to find out how we can help you achieve your goals in the U.S. market.
