Food Safety Strategies was recently able to interview FARE (Food Allergy Research & Education) CEO Lisa Gable on the FDA's new statement on consideration for sesame allergies.

LP: Why is FDA shifting its thinking on this subject?

LG: Allergy to sesame is the ninth most prevalent food allergy in the United States, and reactions to sesame are more severe than reactions to other food allergens, according to new research. While food manufacturers are required to label the “Big 8” allergens (peanuts, tree nuts, milk, egg, Crustacean shellfish, fin fish, wheat and soy), they’re not required to label sesame.

But under the current rules, sesame may be hidden in the labeling for ingredients such as “natural flavors” or spice blends, and manufacturers may not want to disclose proprietary information about their recipes. Undeclared food allergens are the leading reason for food recalls. FDA Commissioner Scott Gottlieb, MD, recently noted that reactions to sesame—which can include potentially deadly anaphylaxis—can occur despite a careful reading of packaged food labels by conscientious consumers, a condition he calls “unacceptable”.

LP: How prevalent are sesame allergies?

LG: Researchers from Ann & Robert H. Lurie Children’s Hospital of Chicago estimate that nearly 8 percent of U.S. children (about 5.6 million) have food allergies, with nearly 40 percent allergic to more than one food. These findings were based on their latest national food allergy prevalence survey, which assessed over 38,000 children. The study, published Nov. 19 in the journal Pediatrics, found that the most common allergens in the U.S. are peanut—affecting about 1.6 million children—followed by allergy to milk (1.4 million), shellfish (1 million), tree nut (900,000), egg (600,000), fin fish (400,000), wheat (400,000) and soy (400,000). Sesame was the ninth most common food allergen, affecting about 150,000 children. Study author Dr. Ruchi Gupta has said that “sesame should be included under allergen labeling laws in the U.S., as is already the case in Canada, the European Union, Australia and Israel.”

LP: Are sesame allergies increasing?

LG: In short, we think so. We know that the frequency of emergency room visits due to anaphylaxis—that’s a severe allergic reaction—caused by any food increased by 377 percent from 2007 to 2016, according to an analysis of health insurance claims by nonprofit FAIR Health. The increase over that period was even more dramatic for the specific category of “tree nuts / seeds” (which includes sesame and other seeds like poppy and flax seeds, as well as tree nuts like walnuts and almonds, but not peanuts). For this category, the frequency of emergency room visits increased by 603 percent.

LP: How will this impact the food industry?

LG: FARE believes the impact on the food industry should be minimal. The industry has been complying with the Food Allergy Labeling and Consumer Protection Act since shortly after it was enacted by Congress in 2004. Food companies are already labeling the “Big 8” allergens, and if FDA were to add sesame to that list it would require changes to some manufacturing processes, but only for certain products. Moreover, as noted above, global food companies already label foods for sesame when they’re sold in Canada, the EU, Australia and Israel. Manufacturers will require a window of time to implement it.

LP: Should FDA be considering labeling regulations related to other minor food allergens?

LG: We support what FDA is doing right now: collecting information from all stakeholders about the scope of the problem, potential regulatory actions, and the costs and benefits of those changes. Labeling sesame is extremely important to people with food allergies, because sesame is the 9^th most prevalent food allergy and reactions to it tend to be severe.

Food allergies are a global epidemic without a cure; however we expect the landscape to change in the future—new treatments for peanut allergy are on the horizon, for example. For that reason, FARE believes that future changes to labeling rules should be more flexible, so that the list of major food allergens can be based on scientific evidence regarding the prevalence, severity, and potency of allergies to those specific foods, and can change as new data might dictate. This approach was recommended by the National Academy of Science, Engineering and Medicine in a 2016 consensus report, and we support it—but it could require action from Congress before FDA can make the changes.