In its draft guidance, the FDA noted how the voluntary measure “does not establish legally enforceable responsibilities” for food manufacturers, rather describes the agency’s “current thinking on a topic and should be viewed only as recommendations, unless specific regulatory and statutory requirements are cited.”
Sesame is currently not classified as a 'major allergen' by the FDA, which defines the 'big eight' major allergens as: milk, eggs, fish, crustacean shellfish, tree nuts (e.g. almonds, pecans, or walnuts), wheat, peanuts, and soybeans (for which allergen labels are required).
The FDA clarified that if whole sesame seeds are used an ingredient, they must be declared on the label. However, under current regulations, sesame can, in some circumstances (such as when used in spice blend), be declared in an ingredient statement as simply 'spice' or 'flavor.'
Thus, said the FDA, "We recommend that manufacturers, as a voluntary matter, clearly declare sesame in the ingredient list when it is used in foods as a “flavor” or “spice” in a parenthetical following the spice or flavor, such as, “spice (sesame),” “spices (including sesame),” “flavor (sesame)” or “flavors (including sesame).
"If a term is used for a food that is or contains sesame, such as tahini, we recommend that sesame be included in a parenthesis, e.g. “tahini (sesame)” in the ingredient list. This voluntary declaration of all sources of sesame in the ingredient list will help consumers, especially those allergic to sesame, avoid foods that could cause an allergic reaction."
FARE: Sesame should be recognized as the ninth top allergen
According to a 2019 study by Northwestern Medicine which surveyed 50,000 US households, researchers found that sesame allergy affects more than 1 million children and adults.
Commenting on the FDA’s voluntary guidance announcement, Lisa Gable, CEO of FARE (Food Allergy Research & Education), said: “On behalf of the 32 million Americans who suffer from life-threatening food allergies, and the 1.5 million Americans allergic to sesame, FARE is disappointed in the FDA’s proposed guidance to industry regarding the ‘Voluntary Disclosure of Sesame as an Allergen’ issued on November 10.
"While the guidance is a step in the right direction, sesame needs to be recognized as the ninth top allergen and it must be labeled.”
FDA: ‘There continues to be a gap in national prevalence data’
The FDA cited a 2017 report issued by the National Academies of Sciences, Engineering and Medicine (NASEM) as part of the basis for its decision, which stated that “… evidence of the allergen prevalence and reaction severity to sesame seeds may warrant their inclusion on the priority allergen list in the United States” (emphasis added by FDA). The agency added that its “evaluation of public information, including scientific and clinical data, revealed data gaps in regional prevalence and severity of sesame allergies.”
However, through a published notice in the Federal Register on Oct. 30, 2018 – which has received over 4,800 comments from consumers, medical professionals, and patient advocacy groups to date – the FDA said that it continues to invite additional data and other information on the prevalence of sesame allergies in the US and the prevalence of sesame-containing foods sold in the US that are not required to disclose sesame as an ingredient.
“For example, we asked for examples of products or product categories that contain sesame as a spice, flavor, color, or incidental additive,” said FDA.
The published findings from the Northwestern Medicine previously-mentioned survey of 50,000 US households have already been submitted to the FDA as public comment as well as other clinical data from CSPI (Center For Science in the Public Interest), to which, the FDA said that it needs to gather more data.
“While we also received some data on incidence or prevalence of sesame allergy cases from several US clinical centers, we note there continues to be a data gap in national prevalence data derived from clinically-based diagnosis of sesame allergy (i.e., with confirmatory testing and/or challenge). This lack of US prevalence data based on clinically confirmed cases of food allergy was also highlighted in the NASEM report and constitutes a gap in assessing the true prevalence of sesame allergy and other food allergies,” the FDA stated.