Researchers led by FDA Food Allergen Coordinator Steven Gendel found about one-third of food recalls between 2009 and 2012 were due to undeclared allergens – a proportion of all recalls that is climbing annually. They noted that recalls due to undeclared allergens accounted for 30% of all food recalls in 2010 and 40% in 2012, according to a consumer update FDA published Oct. 23.
The proportion of recalls due to undeclared allergens continued to climb to 50% of all food recalls conducted in the second quarter of 2014, according to a more recent report from recall management firm Stericycle ExpertSolutions.
The rise might not be due to increased instances of undeclared recalls though. Rather it could be due to firms, consumers and FDA more effectively identifying and reporting the allergens and recalling the products, experts note. Nonetheless, firms can reduce the risk of marketing products with undeclared allergens by taking simple, common-sense steps, FDA researchers and health safety experts say.
Wrong labels No. 1 culprit of undeclared allergens
Using the wrong label is the No. 1 most frequent cause of undeclared allergen recalls, and can be avoided easily and quickly if employees on the production line take a few extra seconds during a product run to confirm the package or label matches the food being processed, Gendel and other researchers say in report released earlier this year by FDA.
They found applying the wrong label or package to foods accounted for 82 out of the 281 food recalls due to undeclared allergens with known root causes conducted between September 2009 and 2012.
Most of these mistakes were due to companies using labels that look similar for multiple products and rushed employees grabbing the wrong package or roll of labels in the middle of a production run, according to the researchers.
Firms also can reduce the risk of incorrectly packaging foods by segregating or storing labels for different products in different spaces rather than “piling all the labels in the same cabinet,” said Robert Brackett, Illinois Institute of Technology VP and director of the Institute of Food Safety and Health.
To further reduce the risk of label mix-ups, he also recommended dedicating a manufacturing line to each product that includes a food allergen. If that is not possible, create a standard operating procedure to check the space around manufacturing equipment after each run to ensure loose labels are collected and properly stored before running production for a different product, he said.
“These are sort of common sense policies and procedures that firms can put in place if they are aware of these risks. But, [one of] the biggest problems is they don’t realize these are problems” so increased education is essential, Brackett said.
Other label-related culprits of undeclared allergens include problems with computerized printing, according to FDA. Firms may use computers to print warnings directly on packages to save money and be more flexible if they substitute ingredients. However, employees can easily click on the wrong file and download an out-of-date warning to be printed on products, causing incorrect allergen warnings, Brackett explained.
He noted emerging technology that assigns a barcode to each ingredient that can be scanned when the ingredient is added to a mixer is one way to keep computer labeling up to date, but there is still the risk that a barcode could be coded wrong originally so it is important to double check files.
Nonspecific descriptions of ingredients can trigger recalls
The second most frequent cause of undeclared allergens was using incorrect or non-specific information in the allergen “contains” statement, the FDA researchers found. For example, a product might list tree nuts, but not the specific type of nut.
Firms also might use the more generic term “nuts” under the impression it will cover all tree and ground nuts if they occasionally substitute one nut for another. However, replacing peanuts for almonds can trigger different allergens and therefore should be specifically labeled, Brackett said.
“Allergens are unique in food safety because they are not contaminants, but they are dangerous and the only way sensitive individuals can protect themselves is if they know specifically what is in a product based on the label. That is why accurate labeling is so important,” Brackett said.
Allergens in ingredients must be labeled on finished products
The third most frequent cause of allergen recalls was failure to transfer allergen warnings on ingredients to the final product, according to the FDA.
This can happen if the certificate of analysis for a bulk ingredient is sent to a manufacturer separately from the actual ingredient lot and the allergen information is not reconciled with the product and the product is not tested, according to FDA.
It also can happen if ingredient supplier reformulates and either fails to tell the finished product manufacturer about the addition or substitution of an allergen or the notification gets lost, unopened in an email box, said Melvin Kramer, president of EHA Consulting Group, Inc.
Brackett recommends reviewing suppliers’ allergen control plans to ensure open lines of communication about reformulation. Auditing suppliers also will reveal any dangerous practices that could lead to a manufacturer “unwittingly adding allergens” to finished products, Brackett said.
Cross-contamination lead to recalls
Cross-contamination also contributes to undeclared allergen recalls, but it is a lesser problem – contributing to only 28 of the 281 undeclared allergen recalls with identified root causes conducted from 2009 to 2012, according to FDA research.
Proper sanitization and education of employees about what tools can and cannot be shared are essential to avoiding cross-contamination, Brackett said.
Emerging risks associated with imported foods
Finally, an emerging cause of undeclared allergen recalls are allergens introduced through imported foods.
About 13.2% of products with undeclared allergens came from imported foods in 2009 before climbing to 19.6% of undeclared allergen recalls filed in 2013, Gendel and his colleagues found.
“This problem goes back to needing to know your supplier’s allergen control process,” Brackett said, adding, “Not all countries acknowledge or treat food allergens the same way as we do in this country and that is the responsibility of the manufacturers to verify” through communication and audits of the suppliers.
Ultimately, he said, all firms need to create a specific allergen control plan that accounts for these risks and incorporates these strategies. Not only will such a plan improve food safety, but it is required by the Food Safety Modernization Act, he said, adding the Preventive Control Rule will be phased in beginning in 2015 based on a firm’s size.