Today, the U.S. Food and Drug Administration (FDA) posted a warning letter issued to Whole Foods Market for a pattern of receiving and offering for sale misbranded food products, necessitating a series of food recalls for allergens. In the last year, Whole Foods Market has recalled more than 30 food products because the presence of major food allergens was not listed on the finished product labels. The FDA noticed similar patterns of numerous recalls by Whole Foods Market for undeclared allergens in previous years as well. These products included a variety of foods sold under the Whole Foods brand primarily in the deli and bakery sections of the store. This is the first time the FDA has warned a retailer for engaging in a pattern of receiving and offering for sale misbranded food products containing undeclared allergens.

Food allergies and other types of food hypersensitivities affect millions of Americans and their families. To protect consumers, U.S. law requires that food or ingredients that contain major food allergens be specifically labeled with the name(s) of the allergen source. The eight foods identified as major food allergens are:

• Milk 
• Eggs 
• Fish (e.g., bass, flounder, cod) 
• Crustacean shellfish (e.g., crab, lobster, shrimp) 
• Tree nuts such as almonds, walnuts, and pecans (complete list of tree nuts)
• Peanuts 
• Wheat 
• Soybeans 

Undeclared food allergens are the number one leading cause of Class I food recalls for at least the last three years. As part of the FDA’s ongoing efforts to address undeclared allergens as the leading cause of food recalls, it has analyzed patterns of recalls and have begun several initiatives to improve industry’s compliance with allergen labeling requirements and reduce undeclared allergen-related food recalls. 

The food industry can and must do better to prevent exposing consumers to incorrectly labeled packaged food which can cause serious and life-threatening harm. Manufacturers should also ensure they have controls in place to prevent the unintentional addition of allergens during manufacturing processes.

In 2020, the FDA sent eight warning letters to companies that have manufactured and distributed foods with undeclared allergens, reminding them of their responsibilities concerning the labeling or control of allergens.

For additional information:

• FDA Warning Letters
• Food Allergies