The FDA has taken a first step towards consideration of adding sesame to the list of allergens required to be identified on food labels. The effort could help protect individuals with sesame allergies.1
FDA Commissioner Scott Gottlieb said the agency is seeing evidence that sesame allergies may be a growing concern in the United States. “Because sesame is not recognized as a major allergen, right now it’s not required to be declared as an allergen on food labels,” he added, in a prepared statement.1
According to the FDA, an estimated 20 people die each year in the United States from food allergy reactions.1 The most severe allergic reaction is anaphylaxis, a life-threatening whole-body allergic reaction that can impair breathing, cause a dramatic drop in blood pressure, and affect heart rate. Anaphylaxis can come on within minutes of exposure to the trigger food and can be fatal. It must be treated promptly with an injection of epinephrine (adrenaline).2
Other food allergy reactions include vomiting, stomach cramps, hives, shortness of breath, wheezing, repetitive cough, shock or circulatory collapse, swelling of the tongue, pale or blue coloring of the skin, dizziness or feeling faint, and a tight, hoarse throat with possible trouble swallowing.2
In his statement, Gottlieb said that in some cases, allergic reactions occur despite a careful reading of packaged food labels by conscientious consumers.1 “To me, that’s unacceptable,” he said.
The undeclared presence of allergens in foods—the leading reason for food recalls—continues to be a significant public health issue and an area of active policy consideration by the FDA.1 Under the Food Allergen Labeling and Consumer Protection Act, federal law requires that foods containing 1 of the 8 “major food allergens”—milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans—declare the food source of the allergen using its common or usual name on food labels. When the law was passed in 2004, these 8 food groups, out of more than 160 identified food allergens, accounted for 90% of serious food allergic reactions occurring in the United States.1,2 Prior to that legislation being enacted, the FDA had found that 25% of sampled foods containing ingredients derived from peanuts or eggs failed to list these allergens on the label.1
“Now, the situation has vastly improved,” said Gottlieb, in his statement.1 “The current law imposes strict requirements that foods containing one of these 8 major allergens be clearly marked for the presence of these allergens, and we work closely with companies on quickly recalling such products from the market if they are mislabeled.”
Studies suggest that the prevalence of sesame allergies in the United States is more than 0.1%, on par with allergies to soy and fish. In addition, sesame is not always specifically listed in the ingredient statement. Products with “natural flavors” or “spices” listed on their label may contain small amounts of sesame, and some foods are labeled as containing “tahini,” a paste made from sesame seeds.1
“Fear of not knowing whether a food contains sesame may lead some people to unnecessarily limit their diets to avoid possible exposure,” said Gottlieb, in his statement.1
In response to the increasing concern over sesame in food products, the FDA has issued a request for information to learn more about the prevalence and severity of sesame allergies in the United States. The agency is seeking input from epidemiologists, nutritionists, allergy researchers, and physicians about their clinical experiences and relevant findings, as well as the food industry and consumers. According to Gottlieb, the FDA's goal is to gain a complete understanding of the risks and to learn more about the potential impact of any future regulatory action that could include new disclosure requirements for sesame.1
1. Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA's new consideration of labeling for sesame allergies [news release]. Silver Spring, MD; October 29, 2018: FDA website. https://www.fda.gov Accessed October 30, 2018.
2. The American College of Asthma, Allergy & Immunology. Food Allergies. ACAAI website. Accessed October 30, 2018.
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