FDA Criticized for Response to Bakers Adding Sesame Allergen

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in Food Allergy, Food Allergy News, Soy & Seed
Published: May 18, 2023
Photo: Getty

A bakers’ group is citing “consumer safety” as the reason for the sudden addition of sesame – now the ninth top U.S. allergen – to numerous baked goods. Meantime, the U.S. Food and Drug Administration’s response to the new practice is being criticized as “tepid.”

The FDA’s position comes just as the American Bakers Association (ABA) is defending commercial bakers for intentionally adding sesame to bread, buns and more in light of the FASTER Act. (The baked goods in question did not previously have sesame as an ingredient.) The act, which took effect in January 2023, afforded sesame status as a top U.S. allergen. 

In a statement, the Center for Science in the Public Interest (CSPI) called out the FDA for not actively opposing the practice of “adding sesame” to food products instead of taking measures to prevent cross-contact.

CSPI argues that the practice, which elevates risks for consumers, violates federal requirements to mitigate allergen risks,” says Sarah Sorscher, CSPI director of Regulatory Affairs. 

The consumer advocacy organization is concerned that manufacturers will not be deterred from adding sesame in the absence of a firm government response, Sorscher says.

The FDA says it “aware that some manufacturers are intentionally adding sesame to products that previously did not contain sesame.” The agency makes the comment in a statement accompanying the release of a new draft Compliance Policy Guide (CPG). 

The draft guidance for FDA enforcement policy on major food allergen labeling and cross-contact, however, does not itself address the intentional addition of sesame. 

Added Sesame: Shrinking Food Options

In its accompanying statement, the FDA notes, “this practice may make it more difficult for sesame-allergic consumers to find foods that are safe for them to consume – an outcome that the FDA does not support.”

“This statement that the agency ‘does not support’ the practice because it limits access doesn’t offer much to discourage companies from adding allergens,” Sorscher told Allergic Living.

Sesame began showing up in baked goods at the end of 2022. As Allergic Living reported, the added sesame raised confusion and concern, just as the FASTER Act was about to take effect.

Under FASTER (short for Food Allergy Safety, Treatment, Education and Research), sesame must now be clearly labeled on food packaging. But as manufacturers intentionally added sesame, this put an increasing number of products off-limits for people managing the allergy. 

Sunny Fenton Dahlin is among those who now have fewer choices because of more sesame. When the mom of 6-year-old Franklin, who is allergic to sesame and peanut, learned of added sesame in baked products, she was angry and scared. 

“This is something that could potentially threaten my son’s life,” says Fenton Dahlin of Excelsior, Minnesota. She is working with her state senator and the state department of health to raise awareness of sesame allergies.

With the sesame situation, the Dahlin family has modified how they shop and eat out, choosing to make most meals at home. 

For example, a night out at Culver’s is off the table because of the addition of sesame flour to their buns. The chain’s local restaurant was a place Franklin and his brother could even enjoy a treat from a peanut-free machine for shakes. But with sesame in the buns, the family no longer feels safe eating there. 

“Our number of options for what and where to eat continues to shrink. It’s really frustrating,” she says.

Lawmakers: Big Concern on Added Sesame

The concern for the safety of consumers like Dahlin has reached Capitol Hill. Eight lawmakers wrote to the ABA in early May 2023, expressing “extreme concern and disappointment” in the baking industry’s response to the FASTER Act. 

FDA Criticized for Response to Bakers Adding Sesame Allergen
Sunny and Franklin Dahlin

The practice of intentionally adding sesame “undermines the trust that people with food allergies place in the food industry,” they wrote

Allergy nonprofit organizations support the congressional members’ action, which is led by U.S. Senator Ron Wyden, and U.S. Representatives Doris Matsui and Patrick McHenry. 

The lawmakers’ letter urges manufacturers to stop the new addition of sesame to baked goods, pointing to the safety of consumers. 

“We strongly condemn these practices and urge your members to take the steps necessary to implement safety control measures. No company should be allowed to avoid the costs associated with safe baking practices and risk public health and safety for those with life-threatening food allergies,” the letter states.

Trade Group Defends Bakers

The ABA responded in a seven-page letter on May 15, 2023, defending its members for their decision to add the allergen as an ingredient to products.

“It is consumer safety, not cost savings, that has driven the decisions of some bakers to add sesame flour to their products,” wrote Eric Dell, ABA president and CEO.

The trade organization’s letter outlines challenges in completely eliminating sesame from baking equipment as compared to other top allergens, especially due to the seeds’ small size. The letter also points to the fact that seeds often are used on top of products, making them easy to fall off and end up in hard-to-reach parts of a facility.

“Sesame is a uniquely challenging allergen to remove from the baking environment, and even the best practices cannot always remove traces of sesame,” the association said in a press release about the letter. The ABA’s defense also notes that manufacturers decided to add sesame flour and label it as such, rather than risk recalls because of cross-contact. 

But Jason Linde, senior vice president of advocacy for the nonprofit FARE, called the ABA’s letter “ludicrous and unbelievable.” 

“Their actions endangered children, enraged parents, and cast a national spotlight on their behavior,” Linde said in a statement. 

In its letter, the ABA calls on the FDA to set allergen thresholds to determine what level of allergen present would put consumers at risk of a reaction. The organization says manufacturers need clear guidance on when a “may contain” label is warranted.

Linde, however, calls this a dodge. “Instead of taking responsibility and complying with the spirit and letter of the law, they are asking the FDA to step-in and establish food allergen thresholds.” 

Sesame Labeling: Next Steps

The lack of communication from the trade association about the manufacturers’ intentions to add sesame was also detrimental, Linde notes.

“Why has there been silence for more than a year if, as the ABA claims, this was all done to protect consumers? FARE was in touch with the ABA throughout the process, and at no time did the ABA ever inform us of their intentions so we could warn our community,” he says.

Dahlin, too, says she is frustrated by the lack of communication to consumers, retailers and food service workers. Sesame flour provides no visual clue that a bread or a bun is new or different, the Minnesota mom notes. “This is a significant allergen that could have a devastating effect for people.”  

The FDA tells Allergic Living that it is monitoring the situation regarding added sesame. 

“We expect that the situation will evolve based on a variety of factors, including individual manufacturer’s business decisions, supply chain demand, and consumer demand,” an FDA spokesperson said. “We are monitoring industry practices and product trends. In addition, we continue to meet with relevant stakeholders, including industry, consumer advocacy groups, and our regulatory partners, to discuss this issue.”

FARE also continues to encourage the FDA to work with lawmakers to find a “potential legislative solution to put an end to this practice,” Linde says.

CSPI is seeking more clarity from the FDA. It submitted a petition in early 2023, asking the agency to clarify that the practice of adding sesame and other major allergens violates food safety rules.

“While the agency considers our petition, it could deter companies with a more forceful statement discouraging the practice,” Sorscher says.

Related Reading:
Bread Suppliers ‘Adding Sesame’ as Seed Becomes Top Allergen
President Signs FASTER Act, Making Sesame Labeling the Law