FDA urged to label sesame as allergen

FDA urged to label sesame as allergen

CSPI asked FDA to require that sesame be disclosed on food labels in the same manner as the "Big 8" allergens since sesame is an emerging cause of severe allergy, affecting up to 500,000 people in the U.S. 

The Center for Science in the Public Interest is asking the Food and Drug Administration to require that sesame be disclosed on food labels in the same manner as milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soy are disclosed. In 2004, when Congress passed the Food Allergen Labeling and Consumer Protection Act, those "Big 8" allergens were understood to account for about 90 percent of allergic reactions caused by food. But numerous food-allergy experts cited by CSPI consider sesame to be an emerging cause of severe allergy, affecting an estimated 300,000 to 500,000 people in the United States. And for those allergic to sesame, the ingredient can trigger life-threatening anaphylaxis.

The 2004 law requires manufacturers to list the common name for allergens on food labels, instead of, or in addition to, their lesser known names. A label for a pasta listing semolina as an ingredient, for instance, must disclose that it contains wheat, and a product with whey must disclose that it contains milk. In the case of sesame, less familiar terms such as tahini and gingelly might not alert a sesame-allergic individual. Moreover, "natural flavorings" or "spices" could contain sesame.

The regulatory petition filed by CSPI also asks that the agency raise awareness among restaurateurs and other food service providers about sesame's potential to cause problems.

A restaurant meal sent Brian Heller's 10-year-old son Garrett to the emergency room in an ambulance, even though the family was assured that the meal contained no sesame. Garrett recovered. But the incident inspired Heller to take action to protect others.

"Consumers allergic to sesame, and the parents of children who are allergic, need to know whenever a food contains sesame so they could avoid a life-threatening adverse reaction," said Heller, 48, a technology lawyer who lives in Vienna, VA. "Parents shouldn't bear that responsibility alone. I don't want my son to die from eating a hot dog bun. As a parent of a child with serious, potentially anaphylactic allergies, I need to know if the buns or breads I'm buying were made on shared equipment with sesame seeds."

Last month, Heller launched a petition on the advocacy cite Change.org urging the FDA to treat sesame as a major allergen.

The Canadian government considers sesame to be a major food allergen and Canada, the European Union, Australia, Israel, and New Zealand all require explicit labeling of sesame-based ingredients. CSPI says the FDA could use its authority under FALCPA, as well as its broader authority under the Food, Drug, and Cosmetic Act, to require that sesame be labeled clearly. In 2009, in response to a 1998 CSPI petition, the agency similarly required food manufacturers using the dye carmine, made from the cochineal insect, to use the words "carmine" or "cochineal" on labels. That substance also causes occasional life-threatening anaphylactic reactions.

"The 2004 law was an enormous advance for those who must avoid one or another common allergen to safeguard their health," said CSPI executive director Michael F. Jacobson. "But an important gap remains. The FDA should act to protect consumers allergic to sesame."

CSPI's petition is co-signed by several prominent allergists, including Wayne Shreffler, director of the Food Allergy Center at Massachusetts General Hospital; Hugh A. Sampson and Scott H. Sicherer of the Jaffe Food Allergy Institute at the Icahn School of Medicine at Mount Sinai in New York City; Robert A. Wood, division chief of allergy and immunology at Johns Hopkins Children's Center in Baltimore; Robert S. Zeiger, director of allergy research at Kaiser Permanente Southern California Region; and Carla M. Davis, assistant professor of pediatrics at Baylor College of Medicine in Houston. The petition also includes first-person declarations from other parents of children with sesame allergies and testimonials from individuals who signed Heller's Change.org petition.


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