Study: Consumers With Food Allergy Are Largely Unaware of US Allergen Labeling Policies


McLean, Va. (February 2, 2021) – Today, FARE, in collaboration with the Center for Food Allergy & Asthma Research (CFAAR) at Northwestern University Feinberg School of Medicine and Ann & Robert H. Lurie Children’s Hospital of Chicago, published a study in the Journal of Allergy and Clinical Immunology: In Practice highlighting that consumers with food allergy are largely unaware of current allergen labeling practices in the United States and that they purchase food products with certain allergen statements more often than others, despite the fact that none of these statements are regulated.

The U.S. currently requires manufacturers to label products if top allergens (peanut, tree nuts, milk, egg, wheat, soy, finfish, crustacean shellfish) are used as ingredients in accordance with the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). However, precautionary allergen labeling (PAL) such as “may contain” or “manufactured on shared equipment” consists of voluntary statements placed by the food industry on their products. There are no clear requirements for how to communicate the risk that allergens may be unintentionally introduced into products, leading to inconsistent labeling practices and confusion among food allergy consumers and manufacturers. 

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Dr Ruchi Gupta
Dr Ruchi Gupta

“This new research shows the confusion around PAL and what the different labels represent causing consumers with food allergy to make their own decisions about the safety of a product based on the wording in the label,” said lead author, Ruchi Gupta, MD, MPH, Pediatrician and Director of the Center for Food Allergy & Asthma Research (CFAAR) at Northwestern University Feinberg School of Medicine and Ann & Robert H. Lurie Children’s Hospital of Chicago.

The researchers asked consumers about their preferences for the label, format and placement of PAL statements in the future. Their top preferences for a PAL statement were “not suitable for people with ___ allergy” (29.3 percent) and “may contain [allergen]” (22.1 percent). They also noted a preference for these statements to be consistently placed on the front of the package and below the ingredient list (39.5 percent).

“These PAL choices suggest consumers with food allergy would prefer clearer, more consistent labeling practices to enable more confident decision-making around PAL,” added senior author, Lucy Bilaver, PhD. “Coming to consensus on a single PAL statement is a crucial next step to improve labeling policy for individuals and families with food allergy.”

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Approximately 8 percent of children and 11 percent of adults in the U.S. are living with potentially life-threatening food allergies. FARE’s Food Allergy Consumer Journey research further found that 85 million Americans avoid purchasing foods containing the top 9 allergens because of their, or someone in their household’s, food allergy or food intolerance. In addition, positive legislative momentum indicates that allergen labeling is top of mind for lawmakers as well. In November 2020, the U.S. Food and Drug Administration issued guidance around voluntary labeling for sesame, and the comment period for this guidance was recently extended to February 25, 2021.

“There are more than 85 million Americans impacted by food allergy, and the movement we’ve seen, especially in Washington and on Capitol Hill, dictates the need for clear and consistent allergen labeling,” said co-author, Anita Roach, Vice President, Health Innovation Strategies and Corporate Ventures at FARE. “This issue is critical for those with food allergy. It needs to be an absolute top priority for policy discussions and is necessary to improve the safety of consumers with food allergy.”

In November, the U.S. House of Representatives unanimously passed the Food Allergy Safety, Treatment, Education and Research (FASTER) Act, which would require that sesame be labeled on food products as the ninth top allergen. On December 9, the U.S. Senate unanimously passed similar sesame-labeling legislation and while the legislative cycle ran out before it could be signed into law, FARE and food allergy advocates across the country aim to have this critical legislation re-introduced in both chambers of Congress in the first 100 days of the new session.

To access the full paper, visit here.

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About FARE

FARE (Food Allergy Research & Education) is the world’s leading non-governmental organization engaged in food allergy advocacy and the largest private funder of food allergy research. Our mission is to improve the quality of life and the health of individuals with food allergies, and to provide them hope through the promise of new treatments. FARE is transforming the future of food allergy through innovative initiatives that will lead to increased awareness, new and improved treatments and prevention strategies, effective policies and legislation, and novel approaches to managing the disease. To learn more about FARE, visit our Living TealTM Channel on YouTube or

About the Center for Food Allergy and Asthma Research (CFAAR)

The Center for Food Allergy and Asthma Research (CFAAR), part of the Institute for Public Health and Medicine (IPHAM) at Northwestern University Feinberg School of Medicine and Ann & Robert H. Lurie Children’s Hospital of Chicago, aims to find answers and shape policies surrounding food allergy, asthma and other allergic conditions.

Led by Ruchi Gupta, MD, MPH, CFAAR conducts epidemiological, clinical, and community-based research to make meaningful improvements in the health of children, adults, and families living with allergic disease. The team is internationally recognized for their research surrounding the prevalence of childhood and adult food allergy in the United States and has contributed significantly to academic research understanding the economic cost of food allergy and asthma. A core mission of CFAAR is to reduce the burden of disease and improve health equity by developing, evaluating and disseminating asthma and allergy interventions, as well as by conducting work to inform local, state, national and international health policy.

To learn more about their center, please visit or email

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