In November 2020, FDA issued a draft guidance, Voluntary Disclosure of Sesame as an Allergen, which strongly encourages food manufacturers to clearly declare “sesame” in the ingredient list on food labels. Sesame is not one of the eight major food allergens required by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) to be declared in allergen disclosures on food labels.[1] However, FDA has identified sesame as a food allergen that can cause severe allergic reactions and has noted an increasing prevalence of sesame allergies in the U.S. population. FDA’s labeling recommendations are intended to help individuals who are allergic or sensitive to sesame to identify foods that contain sesame as an ingredient.
Generally, foods containing sesame will declare “sesame” in the ingredient list as the common or usual name of the ingredient. However, the issue arises where (1) sesame is part of a spice or flavoring and is (legally) declared as simply “spice” or “flavor,” or (2) when the common or usual name of the ingredient (such as tahini) does not specify sesame. In such cases, FDA recommends the following voluntary approaches as best practices for sesame labeling:
- For foods where sesame is used as or in a “spice” or “flavor” – Declare “sesame” in a parenthetical following “spice” or “flavor,” such as: “spice (sesame),” “spices (including sesame),” “flavor (sesame),” or “flavors (including sesame).”
- For ingredients that are or contain sesame but have common or usual names that do not include the term “sesame” (e.g., tahini) – Declare “sesame” in parentheses after the ingredient name, such as: “tahini (sesame).”
This draft guidance serves as an interim step while FDA continues to evaluate the data related to sesame allergies. Although FDA’s draft guidance is not binding and will not be in effect until finalized, food manufacturers would be prudent to consider voluntarily implementing such labeling for the safety of its consumers and to address potential product liability concerns. Although the data is still evolving, FDA reports that recent studies estimate the prevalence of sesame allergies to be similar to that of soy and fish allergies and that severe reactions were reported more frequently for children with a sesame allergy than for children with allergies to the major food allergens.
This draft guidance is also part of FDA’s broader initiative to identify and assess “allergens of public health importance.”[2] Such allergens are those beyond the eight major allergens specified in FALCPA for which FDA intends to designate as requiring additional controls, including potentially allergen labeling. FDA continues to evaluate the emerging evidence to develop factors that will inform these future regulatory actions related to such emerging food allergens. We will continue to monitor FDA’s activity in this space. FDA is accepting comments on this draft guidance until January 11, 2021. Comments may be submitted to Docket No. FDA-2020-D-0530 at regulations.gov.
[1] As background, the Federal Food, Drug & Cosmetic Act (FFDCA) currently requires foods containing one of eight major food allergens to declare that major food allergen on its label using the major food allergen’s common or usual name. See 21 U.S.C. § 321(qq). The eight major food allergens are: milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. FDA does not have authority to amend the eight major food allergens. However, it does have authority under the FFDCA to require labeling for other food allergens not covered by FALCPA. See 21 U.S.C. § 343 note.
[2] See, e.g., FDA Draft Guidance, “Voluntary Disclosure of Sesame as an Allergen” (Nov. 2020) at 5; 85 Fed. Reg. 71,920, 71,921 (Nov. 12, 2020).