The U.S. Food and Drug Administration (FDA) started 2025 with new guidance on non-listed food allergens after detailing requirements CPG companies must follow to label the top nine allergens in a webinar.
The FDA shared in guidance its approach to evaluating food allergens beyond the top nine allergens, including crustacean shellfish, eggs, fish, milk, peanuts, sesame, soybeans, tree nuts and wheat.
As per its guidance on evaluating non-listed food allergens, the agency will consider scientific factors — including the prevalence of a food allergy in the U.S. and the severity of reaction — relevant information related to the labeling and production of food containing the food allergen and provide recommendations on how to identify scientific evidence related to allergens.
“Food allergies affect millions of Americans and their families. Food allergies occur when the body’s immune system reacts to certain proteins,” said Linda Cox, consumer safety officer at FDA’s Office of Nutrition and Food Labeling (ONFL), Nutrition Center of Excellence (NCE) and the Human Foods Program (HFP), in a webinar.
“While promising, prevention and therapeutic strategies are being developed, food allergies currently cannot be cured. Early recognition and learning how to manage food allergies, including which foods to avoid, are important measures to prevent serious health consequences,” she added.
The cost of food recalls: $10 million on average
In 2024, CPG companies and retailers made more than 70 recalls for possible undisclosed allergens, according to FDA’s Recalls, Market Withdrawals, & Safety Alerts. The average cost of a small or medium-sized recall is $10 million, according to Consumer Brands Association research.
Among those, Frito-Lay issued a limited recall of potato chips in Oregon and Washington for an undisclosed milk allergen at end of last year. Additionally, retailers Wegmans Food Markets, Grand Central, 7-Eleven, Meijer and Aldi as well as brands Hammond’s, Popsicle, Prime Foods, Feel Good Foods, 365 Whole Foods and Utz initiated allergen-specific recalls in 2024.
Recalls associated with allergens dropped in 2024 from the year prior, according to the consumer protection non-profit U.S. Public Interest Research Groups (PIRG) Education Fund. In 2023, companies issued 313 recalls with nearly half (49.2%) coming from undeclared allergens, up 27% from the prior year, the U.S. PIRG Education Fund reported.
The history of food allergen labeling requirements
FDA’s food labeling requirements are outlined in Title 21 of the Code of Federal Regulations (21 CFR) and Section 403 of the Federal Food, Drug, and Cosmetic Act and require food manufacturers to list a statement of identity, net quantity of content, Nutrition Facts label, name and place of business, ingredient list, major food allergens and artificial flavoring and coloring or chemical preservatives.
The Food Allergen Labeling and Consumer Protection Act (FALCPA) – which took effect Jan. 1, 2006 - defined allergens as crustacean shellfish, eggs, fish, milk, peanuts, soybeans, tree nuts and wheat and laid out specific label requirements. Additionally, the Food Allergen Safety Treatment, Education and Research Act (FASTER) went into effect on Jan. 1, 2023, and added sesame to the list of major food allergens.
Shortly after FASTER took effect, the FDA partially addressed the “unintended consequence” of the bill, which included manufacturers adding sesame purposely into their products to work around steps to avoid cross-contact.
At the time, the Centers for Science in the Public Interest filed a regulatory petition, calling out the practice of adding allergens to avoid regulatory requirements as “shocking, unprecedented in scope, and has the potential to undermine long-established protections for Americans with food allergies.”
Expectations to the FDA’s food allergen labeling requirements include “highly refined oil derived from one of these foods or an ingredient derived from such a highly refined oil, raw agricultural commodities and a food ingredient exempt under a petition or notification process specified in the law under section 403(w) of the Food Drug and Cosmetic Act,” Cox explained.
How CPG companies can label allergens
CPG companies are required to disclose allergens in one of two ways: naming the allergen in the list of ingredients or using a “contains” statement, Cox explained. For instance, “whey (milk)” would qualify for the first method and a statement that reads “Contains eggs, milk” would satisfy the latter, she added.
Additionally, “these required labeling elements, must be provided in English, unless the food is only distributed in a US territory where the predominant language is one other than English, such as Puerto Rico. Additionally, mandatory labeling for packaged food may not be replaced by QR code or website labeling,” noted Lynn Szybist, director of the division of food labeling and standards at ONFL, NCE and HFP.
Manufacturers that temporarily reformulate their products can use a sticker label as long as the label contains an ingredient list and statement, and the label “completely covers the incorrect ingredient list and contain statement,” explained Mabel Lee, consumer safety officer at ONFL, NCE and HFP.
Editor’s note: The article was updated to include information related to the FDA’s guidance on non-listed food allergens.
