Sesame’s Major Allergen Designation to Impact Food Industry

A new year has arrived, and with it come new FDA requirements governing the labeling and safe handling of sesame and sesame-containing food products. The seed, a popular ingredient in foods across the world, has joined the list of “major allergens” regulated under the Federal Food, Drug, and Cosmetic Act (FDCA). This designation will have significant implications for the food industry and consumers.

Signed into law in April 2021, the Food Allergy Safety, Treatment, Education, and Research Act (FASTER) is just the latest in a long history of amendments to the FDCA, an act that was originally passed in 1938 to combat the proliferation of adulterated and dangerous foods, drugs, and cosmetics. The FASTER Act adds sesame to the existing list of “major food allergen[s]” under 21 U.S.C. § 321(qq)(1), making it the ninth regulated allergen under the FDCA. Sesame joins milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans.

These ingredients originally made up the “Big Eight,” or the eight ingredients targeted for regulation under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). At the time FALCPA was passed, research suggested that the eight ingredients were responsible for 90 percent of food allergies in the United States. FALCPA modified Section 403 (21 U.S.C. § 343) of the FDCA to impose special labeling requirements on all foods containing major allergens. The statute states in part that unless the product is a “raw agricultural commodity,” its label must include either (1) “the word ‘Contains’, followed by the name of the food source from which the major food allergen is derived” or (2) “the common or usual name of the major food allergen” within the list of ingredients. This disclosure requirement is designed to allow consumers to easily identify the presence of food allergens and avoid suffering potentially deadly allergic reactions.

FALCPA also instructed the Secretary of Health and Human Services to perform inspections of food processing, manufacturing, and holding facilities in order to enforce practices that reduce or eliminate unintentional cross-contact between foods and major food allergens. These required practices are laid out in 21 C.F.R. § 117 et seq., titled, “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” The regulations are extensive, covering topics from plant construction and design (§ 117.20(b)) to sanitizing surfaces and equipment (§117.35(a) & (d)). Food manufacturers, processors, and packers must abide by these regulations at all times, “utiliz[ing] quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible.”

Companies may also choose to warn consumers of potential cross-contamination by adding an advisory label, such as “may contain peanuts.” However, the FDA has made it clear that “while advisory labeling that is truthful and not misleading may be acceptable in certain circumstances” it does not relieve compliance with labeling requirements and good manufacturing practices. Failure to conform to these requirements risks exposure to heavy FDA fines and criminal penalties, consumer lawsuits, and mandatory recalls. The risk of recall is especially real; undeclared food allergens are the leading cause of all food recalls. At least three allergen-related recalls have already been declared in 2023.

With sesame’s new status as a major allergen, producers are scrambling to comply with the strict requirements. Many popular restaurant brands like Olive Garden, Chick-fil-A, and Wendy’s have chosen to work around the new requirements by deliberately adding sesame to products that were previously sesame-free and declaring the sesame in accordance with FDCA labeling requirements. They blame food suppliers for the change, claiming that the suppliers are unable to guarantee contaminant-free flour. One thing is for certain— for the time being, companies in the industry will continue to face tough decisions on how to comply with the new sesame requirements.

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The views and opinions expressed in the article represent the view of the authors and not necessarily the official view of Clark Hill PLC. Nothing in this article constitutes professional legal advice nor is it intended to be a substitute for professional legal advice.