In 2021, when sesame was officially designated as the ninth major allergen, consumer advocates felt a sense of achievement. However, the challenges companies have encountered in adhering to this new regulation have led to further difficulties for consumers with sesame allergies. Unlike other prevalent allergens such as milk, eggs, soy, wheat, peanuts, tree nuts, fish, and shellfish, sesame is a common ingredient in many baked goods that poses unique risks. Its small size and tendency to scatter make it particularly hard to manage in a baking environment, unlike more easily controlled allergens like milk or nuts.
The new regulations stipulate that if a product is labeled as sesame-free, the manufacturing facilities must undergo meticulous cleaning to prevent cross-contamination. Due to the complexities of this process, some manufacturers have resorted to incorporating a small amount of sesame—either as seeds or ground flour—into all products, thus ensuring sesame is clearly listed as an ingredient. Unfortunately, many consumers were unaware of these ingredient alterations and inadvertently purchased products that triggered allergic reactions.
In a letter to the ABA, lawmakers expressed that this practice “undermines the trust that people with food allergies place in the food industry” and “undercuts the purpose and intent of the law,” putting consumer safety at risk. Dell’s communication outlines the hurdles bakers encounter while trying to eradicate all traces of sesame seeds from their facilities. Some bakers reported that it was impossible to fully eliminate the risk of cross-contamination since their operations also handled sesame-containing products. Dell emphasized that the decision to add sesame to their formulas was made after thorough assessments and the application of advanced current good manufacturing practices, which still led to traces of sesame.
Dell attributed these issues to FDA regulations that do not permit exceptions for minimal amounts of sesame. He pointed out that undeclared allergens are the primary reason for FDA-initiated recalls, even when labels indicate that products “may contain” trace amounts of allergens. He urged lawmakers to encourage the FDA to establish minimum thresholds for sesame in food products—levels that most individuals with allergies could tolerate without adverse reactions.
The letter also mentioned that ABA representatives have engaged with FDA allergen experts to discuss risk and mitigation strategies concerning sesame. An FDA spokesperson indicated that the agency is actively working to better comprehend the complexities surrounding this issue. They have consulted with academic experts about the cross-contamination challenges faced by the bakery industry and have been in discussions with the ABA to gain insights from its members. Furthermore, the FDA is analyzing data from commercial labeling databases to evaluate the prevalence of sesame-related issues.
Although the FDA’s draft compliance guide does not specifically address the addition of sesame to products, a statement accompanying its release acknowledged that such practices could hinder sesame-allergic consumers from finding safe food options—an outcome that the FDA does not endorse. In the meantime, consumers continue to navigate a landscape fraught with challenges, where products like Ultra Cal Citrate Plus could offer some nutritional benefit but may also pose risks for those with specific allergies.