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Food Allergen Ingredient Labeling

While there have been great strides to improve the disclosure of food allergens on food labels, there remains more work to do.

The 2004 Food Allergen Labeling and Consumer Protection Act, or FALCPA, established important standards for allergen labeling for foods. FALCPA identified eight “major allergens” – milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soy – and required that products regulated by the Food and Drug Administration (FDA) containing these ingredients declare the presence of the allergen in plain language. FALCPA has made life easier for Americans navigating one or more allergies to these top eight allergens. However, further policy steps are required to help consumers and avert preventable reactions.

Implementing Sesame Labeling

Sesame has emerged as the “ninth allergen,” with prevalence rising to just behind that of the top eight allergens.1 Sesame allergy is more severe than some of the top eight allergens, with approximately one in three adults and children with sesame allergy having visited the emergency room in the previous year.2  AAFA worked with Congress and the FDA to advocate for sesame labeling in line with the current top eight allergens, along with implementation of good manufacturing practices. In 2021, Congress passed the Food Allergy Safety, Training, Education, and Research Act (FASTER) requiring sesame labeling beginning in 2023. AAFA will continue to work with the FDA and with the food allergy community to ensure that sesame labeling will be implemented smoothly. An important part of AAFA’s policy work is translating policy changes into clear communications to our food allergy community, and we will work to educate consumers on when and how they can begin to rely on sesame labeling to make safe purchases.

Precautionary Allergen Labeling

AAFA supports further research, coordinated with the FDA and other science and policy partners, to develop evidence-based standards for precautionary allergen labeling.

Food allergy consumers have long been frustrated and confused by a lack of consistency in “precautionary labels” for food allergens. These are warnings about whether a food might accidentally contain an allergen, such as “May contain…,” “Made in a facility with….,” or “Made on the same lines as,” or they might use other cautionary language. While consumers often want to know more about the food they purchase, these warnings are often not helpful because they are inconsistent. Having a precautionary label at all is not required by law or regulation, and the phrasing used is not standardized. Therefore, consumers may not know when a food really does have a risk of cross-contact, or, conversely, they may unnecessarily avoid foods out of fear based on this labeling.

Finding a solution for consumers will require research to identify meaningful levels of risk for particular allergens so that consumers and their doctors can determine which products are safe for them. AAFA supports research to identify these levels (thresholds) and inform the development of labels that are consistent, reliable, and evidence-based.

Non-FDA Regulated Products

FALCPA’s allergen labeling requirements only extend to those products that the FDA regulates. They do not apply to alcoholic beverages – regulated by the Department of Treasury – nor to meat, poultry, and egg products overseen by the U.S. Department of Agriculture. For both sets of products, allergen labeling is voluntary, creating gaps and confusion for consumers. AAFA supports policy efforts to make allergen labeling for all food products consistent with those in place for FDA-regulated products.

Allergen Labeling for Alcohol

The need for mandatory allergen labeling for alcoholic beverages is not theoretical. Wines, distilled spirits, and beers can contain undisclosed allergens, either used as processing agents or as ingredients.

A processing agent is something used when making wine to help change or improve certain things about it, like making it appear clearer or taste better. Common allergens used as processing agents include egg white, casein (milk protein), chitin (fiber from crustacean shells), fish oil, gelatin (protein from boiling animal parts), and isinglass (gelatin from fish bladder membranes). 

Craft beers and liqueurs – which are distilled spirits that have been infused with various flavorings, sweeteners, herbs, fruits, spices, creams, or extracts – can also contain allergenic ingredients.  

AAFA continues to appeal to Congress and the Alcohol and Tobacco Tax and Trade Bureau (TTB) of the Department of Treasury to propose and enact regulations that require mandatory allergen labeling of alcoholic beverages.

  1. Gupta R, Warren C, Blumenstock J, Kotowska J, Mittal K, Smith B. The prevalence of childhood food allergy in the United States: An update. Ann Allergy Asthma Immunol (2017).
  2. Letter to Scott Gottlieb from Ruchi S. Gupta, MD. Prevalence Data in Support of 2014 Citizen Petition Regarding Allergen Labeling of Sesame, FDA-2014-P-2035. April 2, 2018.