Reviewing sesame labeling regulations: FDA examines prevalence and severity of sesame allergies

30 Oct 2018 --- The US Food & Drug Administration (FDA) is investigating the prevalence and severity of sesame allergies as part of considerations to impose regulations on packaged food labels. The FDA said that it would begin collecting information after the country is starting to see evidence that sesame allergies may be a growing concern in the US as some studies suggest that the prevalence of sesame allergies is more than 0.1 percent, on par with allergies to soy and fish.

As sesame is not recognized as a major allergen, right now it’s not required to be declared as an allergen on food labels and it may not always be listed explicitly in the ingredient statement. 

However, products with “natural flavors” or “spices” listed on their label may contain small amounts of sesame, according to FDA Commissioner Scott Gottlieb, who says that people allergic to sesame might eat food labeled as containing “tahini” without knowing that tahini is a paste made from sesame seeds. 

“Fear of not knowing whether a food contains sesame may lead some people to unnecessarily limit their diets to avoid possible exposure,” he says. “The FDA is advancing a new effort for the consideration of labeling for sesame to help protect people who have sesame allergies.”

“As a first step, the agency issued a request for information so that we can learn more about the prevalence and severity of sesame allergies in the US, as well as the prevalence of sesame-containing foods sold in this country.” 

“These include foods that, under current regulations, may not be required to disclose sesame as an ingredient.”

The FDA wants to hear from epidemiologists, nutritionists, allergy researchers and physicians concerning their clinical experiences and relevant findings. It’s also looking for feedback from the food industry and consumers to gain a more 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. 

Gottlieb says that in addition to the growing concerns about sesame allergies, this request for information is designed to help inform the FDA’s response to a citizen’s petition from medical professionals and consumer advocacy groups who asked the Government to require that sesame-based ingredients be explicitly listed by name on the ingredient lists of all food labels. 

The Center for Science in the Public Interest (CSPI) has been campaigning for sesame allergen labeling for several years. It petitioned the FDA in 2014 to require sesame to be labeled in the same way as the “Big 8” allergens – milk, eggs, fish (e.g., bass, flounder, cod), crustacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, walnuts, pecans), peanuts, wheat, and soybeans – that must be disclosed on labels.

Sarah Sorscher, CSPI's Deputy Director of Regulatory Affairs, says the non-profit watchdog welcomes the step by the FDA but says the Agency already has the information and it needs to move directly to a proposed rule requiring sesame labeling.

“Information CSPI has previously submitted to the agency establishes that sesame rivals major allergens in terms of severity and that sesame allergy is close in prevalence to the eight other allergens for which labeling is currently required,” she says. 

“We hope that the information submitted in response to the request will further emphasize the urgent need for the FDA to act quickly in requiring sesame labeling.”

The FDA claims that over the last several years it has worked diligently to implement innovations to speed the detection of allergens in mislabeled foods to curb potential cases of allergic reactions.

This includes the development of xMAP Food Allergen Detection Assay by scientists in the FDA’s Center for Food Safety and Applied Nutrition three years ago. This can detect all of the major food allergens, with the exception of fish, in just six hours. It is considered a great tool in helping to safeguard the food supply by detecting the presence of undeclared food allergens that result from cross-contact during manufacturing.

According to the FDA, researchers are now working to expand this to include sesame which will help to detect and track allergic reactions.

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