Regulatory Update: Sesame Added As Major Food Allergen; FDA Issues Voluntary Guidance For Now

Under the Food Allergy Safety, Treatment, Education and Research Act of 2021 (FASTER Act), sesame has now been added to the list of major food allergens for which labeling disclosures are mandatory.  By January 1, 2023, food companies must declare the presence of sesame on food packaging labels.  Currently, the Food Allergen Labeling and Consumer Protection Act (FALCPA) requires such disclosure for peanuts, tree nuts, fish, shellfish, soy, dairy, eggs and wheat.  Sesame is the first additional allergen to be added to FALCPA’s allergen list since 2006.

While this change in law and regulation is noteworthy, it is not exactly news.  Such labeling already is required globally in Canada, Europe, Australia, New Zealand and Japan. Here in the United States, Illinois became the first state to mandate sesame allergen labeling in 2019.  At the federal level, while Congress was considering the FASTER Act, the Food and Drug Administration (FDA) had already set its sights on sesame as an allergen that required attention. 

According to the FDA, available data suggests that the prevalence of sesame allergies in the U.S. population appears to have increased, that sesame causes a relatively high frequency of severe allergic adverse events, and that allergic reactions to sesame may occur from products with undeclared sesame ingredients.  For these reasons, in November 2020, the FDA issued draft guidance for the food industry requesting that food manufacturers voluntarily disclose the presence of sesame in their products.  The FDA sought comments on the draft guidance through February 25, 2021.  The industry now awaits the FDA’s final guidance. 

In the meantime, for those food companies interested in voluntary disclosure of sesame on its labeling, the draft guidance provides useful recommendations.  Sesame, as a single ingredient, should be declared.  However, sesame can be included as a sub-ingredient in both flavors and spices.  As such, its presence in a finished food product may not be understood by the consumer when reviewing the ingredient statement.  To address this issue, the FDA recommends that food manufacturers, should they choose to begin voluntarily disclosing sesame as an allergen before the FASTER Act’s mandatory compliance date, 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. 

For example:

●  spice (sesame)

●  spices (including sesame)

●  flavor (sesame)

●  flavors (including sesame)

If a term is used for a food that is or contains sesame, such as tahini, the FDA similarly recommends that sesame be included in a parenthesis.  The declaration in the ingredient list would be “tahini (sesame).”  Additionally, beyond the ingredient statement, a food manufacturer should expressly call out the presence of sesame in the allergen statement (ex. CONTAINS:  sesame). Labeling is a critical component of any food product.  Voluntarily declaring all sources of sesame in the ingredient list – in addition to the allergen disclosures already required by FALCPA – will help consumers avoid foods that could cause an allergic reaction.  If you have any questions about your particular food labeling, the Food & Beverage attorneys at Wendel Rosen are here to help.  Please email wacevedo@wendel.com with requests for more information about our services.

Published by Bill Acevedo

I am the Chair of Wendel Rosen LLP's Green Business Practice Group, and I am the Co-Chair of my firm's Food and Beverage Group. My practice focuses on manufacturing and food, dietary supplement and cosmetic companies. I provide outside general counsel services to my clients, which include: entity formation, business and legal advice on proposed business transactions, general contract negotiation and drafting, brand and licensing protection, corporate governance, capital raises, and M&A transactions. Additionally, I assist my clients with labeling, advertising, and FDA regulatory compliance matters. In addition to my corporate transactional practice, I handle all manner of business litigation, such as labeling/advertising claims, contractual disputes, trade secret matters, partnership disputes, product liability claims, director and officer liability, and unfair business practices claims.

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