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Food Allergens, Contamination Risks, and the FDA

2022 Food Allergens and the FDA (Gendel FSN)

Regulatory expert Steven Gendel discusses the many struggles of implementing an effective allergen control system. Nearly 20 years since the passage of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), the misbranding of products with allergens continues to be a leading cause of food recalls both in the U.S. and worldwide.

Presenter Bio: EAS Independent Consultant Steven Gendel has more than two decades of experience as a scientist, risk assessor, and policy coordinator in the FDA Center for Food Safety and Applied Nutrition; in academic positions at Harvard University, the University of Toronto, and Iowa State University; and as the Senior Director for Food Science at the Food Chemicals Codex. He works to protect public health and to leverage safety and integrity systems to enhance success and sustainability. He has worked with food producers, consumer groups, regulators, and industry organizations in the U.S. and internationally to evaluate and improve food safety systems, to meet the challenge of food allergen management, and to protect businesses and consumers from food fraud.

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How Many Major Food Allergens Does FDA Recognize?

The U.S. FDA lists nine major food allergens that must be included on food and beverage labels when they are used as ingredients:



Crustacean Shellfish


Tree Nuts





Sesame is the newest FDA-listed allergen, designated in 2021 by the Food Allergy Safety, Treatment, Education and Research (FASTER) Act. Sesame-containing food, beverage, and dietary supplement products must have compliant allergen labeling in place as of January 1, 2023.

Allergen labeling is required for foods, beverages, and dietary supplements, a subcategory of foods, when any “major food allergen” ingredient is included in the formulation. Allergen labeling must use the specific name of the allergen source, such as the name of the tree nut or species of fish. If the allergen is listed in the product name (such as soy sauce or sesame paste), additional allergen labeling is not required. However, “hidden allergens” that are present in ingredients such as flavors or colors must be listed.

The Preventive Controls Rule requires that manufacturers use GMPs and preventive controls to prevent allergen cross-contact.  Advisory labels (such as “may contain” statements) may be used when appropriate but are not substitutes for effective allergen controls. 

In Addition to Adding Sesame as a Major Food Allergen, What Does the FASTER Act Do?

The 2021 FASTER Act expands FDA’s efforts into understanding food allergens and their risks.

Specifically, it expands surveillance and collection of data on the prevalence of food allergies and severity of allergic reactions for specific food or food ingredients. Through effective food allergy diagnostics, and new therapeutics to prevent, treat, cure, and manage food allergies, the FASTER ACT aims to prevent the onset of food allergies and reduce the risks related to living with food allergies. It tasked FDA to identify and strengthen any gaps in these activities.

Why is Allergen Contamination Risk a Problem for Food Manufacturers?

The complexity of validating cleaning and sanitation practices to control allergens, the limitations of allergen testing in the environment and products, and their unpredictable correlations leave the industry relying mainly on precautionary advisory labels.

How Do Consumer Needs Affect FDA’s Focus on Food Allergen Controls?

Understanding the changes in consumer needs remains as important today as when FALCPA was passed. The recent addition of sesame to the list of Major Food Allergens is just one example of the continuing evolution of the allergen control landscape.

Watch the full webinar for tips on implementing an allergen control system in your facility.

Posted in Foods, On Demand Webinar.