FDA considers adding sesame to list of allergens that must be declared on packaged foods

By Elaine Watson contact

- Last updated on GMT

Picture: istockphoto/piotr_malczyk
Picture: istockphoto/piotr_malczyk

Related tags: sesame

The FDA is issuing a request for information (RFI) on the prevalence and severity of sesame allergies in the US to inform possible regulatory action that would require sesame to be labeled as an allergen on packaged foods along with the ‘big eight’ (milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans).

“Unfortunately, we’re beginning to see evidence that sesame allergies may be a growing concern in the US,” ​said FDA commissioner Dr Scott Gottlieb, who noted that the European Union, Canada, Australia, and New Zealand all require labeling of sesame.

 “A handful of studies, for example, suggest that the prevalence of sesame allergies in the US is more than 0.1%, on par with allergies to soy and fish.”

As sesame is not currently recognized as a major allergen,  it’s not required to be declared as an allergen on food labels, and may not always be specifically listed in the ingredient statement, said Dr Gottlieb, who noted that the FDA had received a citizen petition​ from the Center for Science in the Public Interest (CSPI), several medical professionals, and two consumer advocacy groups urging it to add sesame to the major allergens list.

“Products with ‘natural flavors’ or ‘spices’ listed on their label may contain small amounts of sesame. And 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 added: “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, today the agency issued a request for information so 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.”

The comment period opens October 30, 2018 and will remain open for 60 days.

CSPI: FDA already has the data to act

CSPI deputy director of regulatory affairs Sarah Sorscher said that while it welcomed the FDA's RFI, the agency "already has the information it needs to move directly to a proposed rule requiring sesame labeling,"​ adding: "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.

"We hope that the information submitted in response to today’s request will further emphasize the urgent need for the FDA to act quickly in requiring sesame labeling."

Some examples of questions​ FDA would like answered:

  • What is the prevalence of IgE-mediated sesame food allergies in the US?
  • What is the nature of the allergic response(s) to sesame in food and what are the impacts on consumers?
  • How does the prevalence of IgE-mediated sesame food allergies in the US compare to the prevalence of IgE-mediated allergies to the major food allergens?
  • What proportion of allergic reactions in the US may be attributed specifically to exposure to undeclared sesame? 
  • What are examples of products or product categories that contain sesame as a spice, flavor, color, or incidental additive and that do not list 'sesame' on the product labeling?  

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