On 10 November 2020, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance recommending that companies voluntarily declare sesame in the ingredient list when it is used as a “flavor” or “spice” or when the common or usual name (such as tahini) does not specify sesame, in an effort to help sesame-allergic consumers avoid foods that could cause an allergic reaction.1 The FDA states in the guidance that it is continuing to look at factors that it would consider to potentially amend the regulations to require labeling of other allergens, suggesting that this voluntary draft guidance is an interim measure in a longer-term effort related to allergen labeling, including sesame.
There is no recommended timeline specified in the draft guidance or the Federal Register notice to implement the voluntary disclosures. Further, the guidance was issued in draft form, indicating companies are not expected to implement the voluntary recommendations before a final guidance is issued. Comments on the draft guidance are due 11 January 2021.
Background
In 2004, the Food Allergen Labeling and Consumer Protection Act (FALCPA) amended the Federal Food Drug and Cosmetic Act (FFDCA) to require labeling of eight major food allergens – milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans.2 Although sesame has been identified as a food allergen that can cause hives, vomiting, and wheezing, it is not one of the eight major food allergens.
Under the current regulations, if whole sesame seeds are used as an ingredient, they must be declared on the label. However, the FDA states that sesame can, in some circumstances (such as when ground or used in a spice blend), be declared in an ingredient statement as simply “spice” or “flavor.” In these cases, the presence of sesame may be unknown to consumers.3
In 2014, the FDA received a citizen petition from the Center of Science in the Public Interest (CSPI), along with medical professionals and consumer advocacy groups, requesting the labeling of sesame by that name in the ingredient statement.4 In October 2018, the FDA issued a notice requesting data and information on the prevalence and severity of sesame allergies and the prevalence of sesame-containing food that are not required to disclose sesame as an ingredient.5 According to the FDA, the data and information received in response to the notice indicates (1) the reported prevalence of sesame allergies in the U.S. appears to have increased, (2) when reactions to sesame occur, they can be relatively severe, and (3) there have been adverse event reports related to products containing undeclared sesame.
From this information, the FDA tentatively concludes, “it appears that sesame allergy may be an increasing problem in the U.S. population.” The FDA notes, however, that “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).”
Rationale for action and recommendations for voluntary disclosure
While FALCPA focuses on the eight major food allergens, the draft guidance states, “Congress made clear that the new statutory requirements did not alter the FDA’s authority under the FFDCA to require a label or labeling for other food allergens.”6 Accordingly, the FDA is currently working to develop a set of factors for evaluating which food allergens beyond the eight major food allergens should be subject to additional controls, including possible labeling requirements.
As an interim measure, the FDA is recommending that manufacturers voluntarily 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, FDA recommends that sesame be included in a parenthesis, e.g. “tahini (sesame)” in the ingredient list.
We will continue to monitor developments related to this guidance and allergen labeling.
References
1 Voluntary Disclosure of Sesame as an Allergen: Guidance for Industry (November 2020) available at https://www.fda.gov/media/143521/download; See also, Voluntary Disclosure of Sesame as Allergen: Draft Guidance for Industry (10 November 2020) (to be published in the Federal Register 12 November 2020) available at https://public-inspection.federalregister.gov/2020-24727.pdf.
2 21 U.S.C. § 321(qq)(1).
3 21 U.S.C. § 343(i); 21 CFR 101.4.
4 Citizen Petition, Requests that the FDA require sesame based ingredients to be listed by name (sesame) in the ingredient lists of all foods, Docket No. FDA-2014-P-2035, available at https://beta.regulations.gov/docket/FDA-2014-P-2035.
5 83 Fed. Reg. 54594 (30 October 2018).
6 21 U.S.C. § 343 note. In the Constituent Update announcing the draft guidance, FDA stated: “The FDA does not have the authority to amend the eight major food allergens established by FALCPA; however, it has the authority under the Federal Food, Drug, and Cosmetic Act to require labeling for other food allergens not covered by the requirements in FALCPA.” Constituent Update, FDA Issues Draft Guidance for Industry on Voluntary Disclosure of Sesame When Added as Flavoring or Spice (10 November 2020) available at https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-draft-guidance-ind ustry-voluntary-disclosure-sesame-when-added-flavoring-or-spice.
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