Have a food allergy? What to know about FDA's new guidance

Food allergy in the US

Approximately one in 10 people in the United States have a food allergy. Most recently, allergen labels changed when sesame became the official ninth major allergen in the US with the passage of the Food Allergy Safety, Treatment, Education, and Research Act in 2021, commonly known as FASTER, joining eggs, soy, milk, wheat, crustacean shellfish, peanuts, tree nuts, and fish as ingredients that must be listed by their common names in the ingredients list of any food that contains them, or must be listed in a separate “Contains” statement near the ingredients list.  These nine ingredients account for 90 percent or more of allergic reactions in the US.

Why allergen labeling matters 

Some 32 million Americans, 5.6 million of whom are children, are allergic to at least one food, and 40 percent of children with food allergies are allergic to more than one food. Reactions to an allergen range from mild—itchiness in the mouth or skin, hives, and nausea—to severe, including shortness of breath and swelling of the throat and mouth. While not every reaction is deadly, some are; anaphylaxis requires immediate medical treatment and could result in coma or death. 

Symptoms of an allergic reaction occur within minutes or a couple of hours of eating a food. They include hives; flushed skin or rash; tingling or itchy sensation in the mouth; face, tongue, or lip swelling; vomiting; diarrhea; abdominal cramps; coughing; wheezing; dizziness; lightheadedness; swelling of the throat and vocal cords; difficulty breathing; and loss of consciousness. 

In a recent survey, more than half of participants with a food allergy reported experiencing at least one severe food-allergic reaction, and more than a third reported one or more food-allergy-related emergency room visits.

FDA's failure to protect food-allergic Americans 

Unfortunately, the U.S. Food and Drug Administration has not taken effective action to allow these consumers to avoid allergens when buying food. There is still no comprehensive system to define what precautionary allergen labels like “may contain” mean, which are commonly used by the food industry. That means consumers can never know the actual risk of undeclared allergens in the products they buy. In addition, due in part to the FDA's failure to give clear guidelines for the food and beverage industry, some food companies are leveraging a loophole and adding some allergens to the recipes for all their foods to avoid having to prevent cross-contamination. 

Learn more: Sesame allergy: Food manufacturing shortcut creates new risks

Newest guidance is no improvement

Rather than address these issues, the FDA has recently stated it may simply allow food companies to ignore small amounts of allergen contamination when designing food safety programs to address allergen risks. 

The FDA’s recent draft guidance, titled “Chapter 11: Food Allergy Program of the Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry,” suggests that companies can use such “thresholds” in designing preventive controls to protect against allergen cross-contamination. However, the FDA leaves it up to food companies to decide what these thresholds might be and how to ensure that consumers are not put at too much risk by the contamination. 

This approach could put consumers at risk, particularly if food companies aren’t careful about keeping contamination levels low.

How you can help CSPI prevent food allergen cross-contact 

The FDA has not taken effective action to help consumers avoid allergens through clear and accurate precautionary allergen labels, like “may contain,” to declare potential cross-contamination risks. Worse, some food companies are leveraging a loophole and adding some allergens to the recipes for all their foods to avoid having to prevent cross-contamination. Rather than address these issues, the FDA recently stated it may simply allow companies to look the other way when small amounts of allergen contamination are found in a product that should be free of that allergen. Tell the FDA that this approach could put consumers at risk. 

CSPI encourages readers and supporters to urge the FDA to retract its discussion of thresholds in this guidance, create a comprehensive approach to cross-contact risks that includes providing guidance that clearly defines accepted precautionary allergen labeling, and bans the intentional addition of allergens to skirt food safety requirements.

Tell FDA: Go Back to the Drawing Board on Food Allergen Rules