Yesterday, FDA’s Center for Food Safety and Applied Nutrition (“CFSAN”) issued a draft guidance regarding the voluntary labeling of sesame when used in flavoring or spice or in a food declared by another name, such as tahini. The Federal Register notice will officially be published on Thursday. We briefly summarize the draft guidance below to help inform stakeholder comments, which are due to FDA by January 11, 2021.
Voluntary Disclosure of Sesame as an Allergen Draft Guidance
Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), any food bearing or containing a major food allergen (milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans) must declare the allergen on the label using its common or usual name.[1] When the FDCA was amended in 2004 by the Food Allergen Labeling And Consumer Protection Act (“FALCPA”) to establish these eight major allergens, FALCPA did not take away the FDA’s general authority to require the labeling of other allergens under their common or usual name.
A common or usual name means a name that accurately identifies or describes, in simple and direct terms, the nature of the food or ingredient. Exempted from this requirement is the labeling of flavoring or spices which can be labeled as “spice” or “flavor.”[2] FDCA section 403(x) gives FDA the authority to require by regulation the disclosure of coloring, flavorings, spices, or incidental additives that contain an allergen other than the major eight.
In 2014, FDA received a citizen petition from the Center for Science in the Public Interest (“CSPI”) requesting that FDA require the labeling of sesame as an allergen. Although FDA has not developed a set of factors for determining which allergens beyond the major eight should be included in allergen labeling, the increasing concern about sesame allergies has caused FDA to provide voluntary recommendations for sesame labeling.
On October 30, 2018, FDA published a notice asking for information and data on the prevalence and severity of sesame allergies in the U.S. and the prevalence of foods that contain sesame but where sesame is not required to be disclosed as an ingredient. FDA received over 4,800 comments. Some of the data included studies finding that 0.2% of children and 0.2% of adults have a reported sesame allergy. For reference, 0.5% of children have a reported soy allergy and 0.4% of adults have a reported pistachio allergy. The authors in the children’s study also found that two-thirds of children who have a reported sesame allergy have visited an emergency room. FDA also received, through the CFSAN Adverse Event Reporting System (“CAERS”), over 500 individual adverse event reports relating to sesame. The most common foods causing adverse events were hummus, tahini, halvah, and baba ghanoush. FDA’s review found that one in four adverse events were due to sesame being undeclared.
Under current statutes and regulations, whole sesame seeds must be declared on a label. However, under certain circumstances, for example when sesame is used in a spice blend, sesame can be declared as “spice” or “flavor.” FDA now recommends manufacturers clearly declare sesame when used as a “flavor” or “spice” by following those ingredients with a parenthetical, for example, “spice (sesame),” “spices (including sesame),” “flavor(sesame)” or “flavors (including sesame).” In addition, FDA recommends any ingredient that contains sesame have a similar parenthetical following it, for example, “tahini (sesame).” This voluntary disclosure using the common or usual name will help sesame allergic consumers avoid products that could cause an allergic reaction.
As with any draft guidance, FDA welcomes any interested stakeholder’s comment to the docket.
It is worth noting that there has been movement to make the declaration of sesame mandatory. At the federal level, a bipartisan bill was proposed in Congress, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, to make sesame one of the major food allergens. Additionally, on November 10, 2020, the Senate Committee on Appropriations included in its explanatory statement regarding FDA funding for FY 2021 a statement that “The Committee urges the FDA to act swiftly to address this risk [of undeclared sesame] by requiring the same labeling for sesame as other major food allergens.” At the state level, Illinois passed a law last year mandating the declaration of sesame.
If you have any questions concerning the FDA updates discussed in this client alert, please contact the following members of our Food, Drug, and Device practice.
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