Navigating Food Allergen Labeling Requirements

By Adam Friedlander, MS, CFS, Manager, Food Safety and Technical Services, FMI

The food industry has a duty to protect consumers with food allergies. Individuals with food allergies rely on the information provided via product labels or signage when making their purchasing decisions. Therefore, all food allergen labels must be truthful of their contents and not misleading. Yet, undeclared allergens on food labels continue—year over year—to be the leading cause of food recalls in the United States. In 2021, undeclared allergens accounted for 47% of FDA recalls and 24% of USDA recalls. Many of these recalls were due to labeling errors, such as the omission of allergens on product packages or using incorrect labels. Verifying the accuracy of allergen information on food labels throughout the entire supply chain is critical to protect the estimated 32 million people in the nation who live with food allergies.

According to Food Allergy Research and Education (FARE), each year over 200,000 Americans require emergency medical care due to allergic reactions caused by food. The symptoms and severity of food allergy reactions can vary, ranging from a mild response (such as itchy, tingling tongue) to life-threatening anaphylaxis. While prevention and therapeutic strategies are being developed, food allergies currently cannot be cured, and thus must be avoided to prevent illness.

An accurate label is not only critical to informing the consumer of the contents of the item, but it is also a regulatory requirement. Under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), packaged foods are required to comply with federal allergen labeling requirements. Any packaged food containing one or more of the eight current major food allergens (e.g., milk, egg, wheat, peanuts, soybeans, tree nuts, fish and crustacean shellfish), or containing protein derived from the eight major allergens must be declared on the food label.

In April 2021, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act was signed into law, which adds sesame as the ninth major food allergen recognized under FALCPA effective on January 1, 2023. So now is the time for retailers, wholesalers, and product suppliers to update labels to declare sesame as a major allergen on all products containing sesame as an ingredient. Many companies are already voluntarily declaring sesame on the allergen label prior to the law’s effective date.

The foundational food safety regulations include consideration of allergens as chemical hazards that need to be controlled through food safety plans (FDA) or HACCP plans (USDA). FDA’s “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” rule (CGMP & PC rule, 21 CFR part 117) establishes requirements applicable to establishments that manufacture, process, pack, or hold human food. The CGMP & PC rule includes requirements for allergen preventive controls to prevent allergen cross-contact in manufacturing and packaging and to prevent undeclared allergens via product labels throughout the food supply chain.

To help the food industry prepare for the inclusion of sesame as a major food allergen, FMI and SQFI hosted a roundtable with Mérieux NutriSciences on January 27, 2022, to discuss methods that help protect brands and consumers with effective allergen management processes. One of the greatest takeaways from this roundtable discussion was that there is not one standard approach for allergen management and each facility needs to determine its own preventive controls based on risk.

The FMI and SQFI teams continue to help companies enhance their food safety plans to prevent undeclared allergens and mitigate the risk of allergen cross-contact. To learn more about allergen management, please visit the following resources:

FMI GUIDANCE FOR RETAILERS: PRODUCT RECALLS

FMI RETAIL ALLERGEN RESOURCE DOCUMENT

IFPTI/FMI ALLERGEN AWARENESS FOR FOOD EMPLOYEES IN RETAIL GROCERY SETTINGS

FMI SAFEMARK