FDA Steps Up Efforts to Protect Public from Food Allergens

 By: Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition

Millions of Americans have food allergies and may experience adverse reactions to products that contain food allergens. Eight foods have been identified as major food allergens, and the U.S. Food and Drug Administration is aware of other food allergens, such as sesame. Most allergic reactions cause mild symptoms, but some are severe and may even be life-threatening. The FDA uses its authorities to help protect those with food allergies and is implementing initiatives to build on the agency’s important work. Our goals are to provide consumers with the information they need to make informed decisions, to enforce regulations that require the industry to properly label food allergens, and to significantly minimize or prevent the presence of undeclared major food allergens in food. 

Emphasis on Prevention and Protection

The Food Allergen Labeling and Consumer Protection Act has been in place for many years and greatly improved the FDA’s ability to inform consumers about the presence of major food allergens in food. Under this law, packaged foods must identify the source of all major allergens used to make the food. The Act identified the following eight allergens as major: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. The allergen's food source must be declared on the food label in one of two ways—in parentheses following the name of the ingredient, such as flour (wheat), or immediately next to the list of ingredients in a statement that says “Contains wheat, milk, and soy.” This requirement is met if the common or usual name of an ingredient already identifies that allergen's food source name (for example, buttermilk). 

We know that the eight major food allergens are not the only food allergens or allergenic substances that can cause problems in sensitive individuals, and that is why the FDA monitors the food supply to determine if other substances pose a significant public health risk. In November 2020, we issued a draft guidance for industry to encourage manufacturers to voluntarily declare sesame in the ingredient list when it is used as a flavoring or spice, or when the common or usual name, such as tahini, does not specify sesame. We know that sesame allergies in the U.S. population appear to have increased, and severe reactions have been reported. This draft guidance is an initial first step while we explore other potential actions to protect consumers who may have allergies to sesame or other food allergens beyond the major eight.  

Gluten is a substance that can pose a risk to individuals with celiac disease. Gluten is found in certain grains such as wheat, barley and rye and when consumed can trigger an immune response that attacks and damages the lining of the small intestine. In 2013, we took the much-needed step to protect people with celiac disease by issuing a final rule defining “gluten-free” for food labeling, which helps consumers be confident that food items labeled “gluten-free” meet a defined standard for gluten content. Following this, in 2020, we took another important step forward with a related final rule to establish compliance requirements for gluten-free labeling for fermented and hydrolyzed foods, such as pickles, soy sauce and cheese, so that consumers can be confident that manufacturers who declare their products as gluten-free know how the FDA will be enforcing the defined standards for these foods as well. 

In addition to these requirements regarding food labeling, as part of the Food Safety Modernization Act, the FDA has in place requirements for certain facilities to implement preventive controls in their manufacturing operations to significantly minimize or prevent the hazard of undeclared major food allergens. This places an emphasis on preventing allergen contamination, protecting consumers, and reducing the need for food recalls.

Commitment to Compliance and Enforcement

Undeclared food allergens have been the number one leading cause of Class I food recalls for at least the last three years. Approximately one-third of foods reported to the FDA through the Reportable Food Registry as serious health risks involve undeclared food allergens. Since March 2020, the FDA has sent warning letters to eight registered food facilities that have manufactured and distributed foods with undeclared major food allergens that resulted in Class I recalls. Those registered food facilities are required by statute to implement food safety preventive controls that significantly minimize or prevent the hazard of undeclared major food allergens before the food is distributed. 

Also, recently, the agency sent a warning letter to Whole Foods Market for a series of major food allergen related recalls. Over the last year, Whole Foods Market has recalled more than 30 food products because the presence of major food allergens was not indicated on the finished product labels. These products included a variety of foods sold under the Whole Foods brand primarily in the deli and bakery sections of the store. This warning letter is the first time the FDA has warned a retailer for engaging in a pattern of misbranding food that they labeled. The food industry must and can do better to prevent exposing consumers to incorrectly labeled packaged food, which can cause serious and life-threatening harm.  

Finding problems before they can potentially harm consumers is a critical element of the FDA’s allergen enforcement program. The FDA inspects food manufacturers to determine whether food facilities have appropriate controls in place to significantly minimize or prevent the hazard of undeclared major food allergens. The FDA also monitors the information received through the Reportable Food Registry to target inspection programs to where problems are occurring. In addition, we conduct periodic sampling assignments to gather information to see if there are problems for specific foods. We also monitor and evaluate consumer complaints to determine if action is needed to improve product safety, communicate information to consumers, or in some cases, remove a product from the market. For example, the FDA recently released results from sampling of domestically manufactured dark chocolate bars and dark chocolate chips labeled as “dairy free” or with similar claims. The sampling was conducted to better understand the extent to which these products contain levels of milk that might cause serious health consequences to consumers with milk allergy.

Exploring and Implementing Emerging Science, Research and Methods

The science of food allergies is rapidly evolving, and we are always on the lookout for the latest research that can help us to address emerging issues and help protect consumers. We initiate research where appropriate and evaluate research from all sources to inform our policy decisions.

Analytic methods to detect allergens in food is another area where scientific developments are needed. The FDA is doing our part to advance analytic methods for use in the laboratory that can rapidly detect multiple allergens. 

The FDA is committed to exploring what further steps we can take to better protect consumers with food allergies. We commit to keep you informed as we make further progress.