In Push for FDA Action, Researchers Release More Details About Severity of Sesame Allergy

Using a survey of nearly 52,000 households across the United States, researchers found an increasing prevalence of sesame allergy, making it the ninth most common allergy in the United States. The findings were presented at the 2019 Annual Meeting of the American Academy of Allergy, Asthma & Immunology in San Francisco, California Saturday.

The survey collected responses for 78,853 US children and adults, finding that 0.2% of individuals in the United States are allergic to sesame, which approaches the prevalence rates of other allergens such as soy and pistachio. The data, as well as other results from previously released findings from this data set, are being used in an effort to convince the FDA to add sesame to the list of other “top 8” allergens that must appear on manufactured food packages.

By age, the highest prevalence rates were observed among young adults aged 18 to 29 (0.33%), while the lowest rates were seen among adults 60 or older (0.09%).

On Saturday, researchers gave additional details about sesame allergy:

• More than half of individuals with a sesame allergy have gone to an emergency department for food allergy.
• 38% report at least 1 severe allergic reaction to sesame, with 1 in 3 reporting a sesame allergic reaction that was previously treated with an epinephrine autoinjector.
• Approximately 4 in 5 people allergic to sesame have additional food allergies.
• Individuals whose income was $50,000 or more had significantly higher odds of having a sesame allergy.

The survey was completed in 2015 and 2016.

Because sesame is not listed as a major food allergen, those with the allergy are vulnerable to accidental exposure, which can turn into anaphylaxis. Labeling is inconsistent in the United States—a few companies voluntarily label for sesame, but not all. However, the seed is labeled on packages in Canada, Australia, New Zealand, and the European Union.

In the United States, federal law was changed in 2004 to require that manufacturers label food for the 8 major allergens that cause most reactions: milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans.

Last October the FDA put out a request for comments about adding sesame to that list and so far has received 4821, which are overwhelmingly in favor of making the change.

In 2014, the Center for Science in the Public Interest (CSPI) asked the FDA to add sesame. The sesame research from Northwestern University is aimed at helping that effort. In a comment posted to the FDA, CSPI said a further request for information by the FDA is “itself unnecessary as a first step toward sesame labeling, insofar as it may delay more decisive action by the agency.”

“With evidence mounting that sesame allergy is on the rise, and can result in severe reactions, we are hopeful that the Food and Drug Administration will take these data into account as they determine whether or not to add sesame to their list of major food allergens,” Ruchi S. Gupta, MD, MPH, said in a statement. Gupta is a professor of Pediatrics and Medicine, Northwestern University, and director of the Science and Outcomes of Allergy and Asthma Research Program.

Earlier this week, an FDA spokeswoman said in an email to The American Journal of Managed Care^® that it does not comment about the timing of future actions and it is “currently reviewing the comments submitted to the docket to help inform us of next steps.”

Reference

Chadha AS, Doshi P, Warren CM, et al. Epidemiology of sesame allergy in the United States. Presented at: American Academy of Allergy, Asthma & Immunology 2019 Annual Meeting; February 22-25, 2019; San Francisco, CA. Abstract 615.