Food allergies are known to affect millions of Americans annually, and a new study has confirmed the growing prevalence of serious reactions to food allergens. Between the years 2007 and 2016, the number of serious allergic reactions to food spiked nearly 400 percent in the United States, according to a report by FAIR Health.

As insurance claims surged within the past decade, product recalls and consumer lawsuits against food companies due to allergen labeling errors have also increased. The complexity of the global food supply chain is creating new headaches for food manufacturers trying to control allergen hazards. As demonstrated in recent years, the undisclosed presence of an allergen in one ingredient (e.g. ground cumin or cumin powder) can trigger recalls of a wide variety of finished products.

Due to the growing prevalence of food allergies, the North American food regulatory agencies have imposed new labeling rules and other requirements. As food allergies and related recalls increase, the industry should expect increased pressure from consumers and regulatory agencies. An effective allergen control program is vital for food manufacturers to meet all regulatory requirements and to reduce the risk of recalls.

New Data on a Growing Health Issue

Within the report Food Allergies: A Growing Health Concern, the independent health information organization, FAIR Health, summarized data on food allergies from a database of 24 billion medical and dental claims from 150 million privately insured people. Based on this data, FAIR Health determined the number of insurance claims due to anaphylactic food reactions rose 377% between 2007 and 2016. While food allergies are typically associated with children, the FAIR Health data revealed that 34% of the insurance claims were associated with patients 18 years or older.

The FAIR Health data also indicated 33% of claims did not identify the allergen responsible for the reaction. Of the allergens identified, the most common included peanuts (26%), tree nuts and seeds (18%), egg (7%), crustacean (6%) and dairy (5%).

Food Allergies Are More Common

Food allergies are estimated to impact the lives of up to 15 million people, including up to 8% of children, in the United States. The Food Allergy Research & Resource Program (FARRP) estimated that  3.5% to 4.0% of the overall U.S. population have a food allergy. In recent years, several research studies have also confirmed an upward trend in the presence of food allergies among Americans.

Based on data from the National Health Interview Survey, a CDC report indicated that food allergies among children increased by 50% between 1997 and 2011 (Jackson et al, 2013). Moreover, researchers from Lurie Children’s Hospital of Chicago reported a 29% annual increase in the rate of emergency department visits and hospital admissions due to food-induced anaphylaxis among children in Illinois between 2008 and 2012 (Dyer et al, 2015).

Children with food allergies are typically expected to outgrow their allergies, but it has become more common for food allergies to persist into adulthood (Kattan, 2016).

Upward Trend in Food Recalls

The number of FDA food recall events due to undeclared allergens increased 103%, and the number of FSIS recalls of meat and poultry due to allergen labeling errors doubled between the years 2010 to 2016. During this period, the number of allergen-related food recalls and alerts increased by 46% in Canada.

Bakery, prepared foods, dairy, chocolate and confectionery products are most commonly identified in allergen-related recalls and the allergens frequently implicated in recalls include milk, nuts (peanuts and tree nuts), wheat and soy.

Evolving Regulatory Approach

In the United States, eight food allergens (wheat, crustacean shellfish, eggs, fish, peanuts, milk, tree nuts, and soybeans) account for approximately 90% of all food allergy reactions. Due to the significance of food allergens for certain individuals, the FDA implemented the Food Allergen Labeling and Consumer Protection Act (FALCPA) to require manufacturers to disclose the major food allergens known as the ‘Big 8’ in packaged foods.  

Improper or ineffective Good Manufacturing Practices (GMPs) are the underlying reason for the vast majority of food recalls. The FDA has defined GMP-related issues as any problem that could be avoided through the use of preventive measures, such as employee training, equipment sanitation and labeling reviews. Cross-contact during processing, ineffective sanitation, incorrect terminology and the failure to properly declare allergens from all ingredients are common reasons for allergen-related recalls.

Due to the sustained increase in food recalls due to allergens, the food regulatory agencies in the U.S. and Canada have unveiled several regulatory initiatives in recent years.

  • The FDA’s FSMA rule for preventive controls addresses allergen cross-contact during manufacturing and the agency is expected to publish a final rule this year regarding Gluten-Free Labeling of Fermented or Hydrolyzed Foods.
  • The USDA Food Safety and Inspection Service (FSIS) developed verification and inspection activities, including Directive 7230.1, to reduce the presence of undeclared allergens in meat and poultry products.
  • In Canada, regulatory amendments, effective August 2012, addressed the labeling of specific priority allergens, gluten sources and added sulfites in prepackaged foods. The food labeling amendments, published a few months ago in the Canada Gazette (16 Dec 2016), will affect the Contains statement and Allergen Precautionary labeling.
  • Due to the growing prevalence of food allergies, the food industry should expect to see an increase in consumer complaints associated with the presence of undeclared allergens at the retail and foodservice levels.
  • Effective employee training and well-designed allergen management programs are critical for establishments seeking to ensure the integrity of their product, protect their company from damaging liability claims and minimize the risk of costly recalls.

Manufacturers can protect consumers from allergic reactions and their brands from costly product recalls due by testing their products for the presence of allergens. Some of the most common allergens are milk, eggs, soybeans, fish, peanuts, nuts, shellfish/crustaceans, and gluten. Mérieux NutriSciences provides testing services to help manufacturers verify control programs and meet customer and regulatory requirements. To ensure your products don’t hit the shelves with undeclared allergens, Mérieux NutriSciences is offering 10% off all allergen testing services in September for National Food Safety Month! Start testing now. 



Meet the Author

Patrick Kennedy
Information Services Manager, Mérieux NutriSciences

Patrick Kennedy is the Information Services Manager for Mérieux NutriSciences. He has over 15 years of food industry experience and has written extensively covering a wide range of food safety and regulatory subjects. He holds a MS degree in information science from the University of Illinois, and is a member of several industry organizations including AOAC, IFT and IAFP.

  1. These statistics are unnerving – with such an increase in food allergies, food manufacturers need to take every precaution to ensure their allergen testing, and their labeling is accurate. Thanks for this article and all your insight!

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