The Mechanics of the Sesame Loophole: How Cross-Contact Rules Led Bakers to Intentionally Add Allergens, and How the FDA is Responding
To avoid the massive costs of zero-tolerance cross-contact rules, commercial bakeries began intentionally adding sesame to previously safe products. Now, the FDA is exploring a science-based threshold model to close the loophole.
By Baran Demir
- Allergy Advocacy Groups
- Argue that intentional addition subverts the law, artificially limiting safe food choices for allergic consumers.
- Commercial Food Manufacturers
- Argue that zero-tolerance cross-contact rules are physically and financially impossible to meet in shared facilities.
- Regulatory Agencies
- Focus on shifting the framework from binary ingredient disclosure to science-based thresholds to protect public health.
Common questions
Why are bakeries adding sesame to plain bread?
To avoid the high costs and liability associated with preventing cross-contact. By intentionally adding a small amount of sesame, they can legally label the product 'Contains: Sesame' and bypass strict zero-tolerance sanitation rules.
Is it legal for companies to do this?
Yes. The FDA has confirmed that intentionally adding an allergen and properly declaring it on the label does not violate the FASTER Act, though the agency strongly opposes the practice.
What is an allergen threshold?
An allergen threshold is a scientifically determined minimum amount of an allergen protein required to trigger a reaction. Establishing a threshold would allow trace amounts below that level to go undeclared, removing the incentive to intentionally add allergens.
The short answer
- The FASTER Act designated sesame as the ninth major U.S. food allergen in 2023, requiring strict cross-contact prevention.
- To avoid the high costs of eliminating cross-contact, many commercial bakeries began intentionally adding sesame to previously safe products.
- The FDA has criticized the practice and issued warning letters, but the intentional addition of labeled allergens remains technically legal.
- In 2026, the FDA began exploring a shift toward risk-based allergen thresholds to remove the incentive for intentional addition.
To comply with a federal law designed to protect people with sesame allergies, America's largest commercial bakeries are intentionally adding sesame flour to the plain white bread, hamburger buns, and snacks you pack for lunch. It is a regulatory paradox that has left allergic consumers scanning grocery aisles with fewer safe options than before, prompting the U.S. Food and Drug Administration to rethink how it regulates food allergens from the ground up.[7]
The situation stems from the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, which officially designated sesame as the ninth major food allergen in the United States. When the law took effect on January 1, 2023, it required manufacturers to clearly declare sesame on product labels and, crucially, to implement stringent controls to prevent cross-contact in their facilities.[1]
For the baking industry, preventing cross-contact is a monumental physical challenge. Sesame seeds are tiny, static-prone, and notoriously difficult to scrub out of the crevices of industrial dough mixers, wire conveyor belts, and massive commercial ovens. Sesame flour dust can drift through the warm air of a bakery and settle onto adjacent production lines, making a truly sesame-free environment incredibly expensive to maintain.[3]
Faced with the choice of either building entirely separate, dedicated sesame-free facilities or risking costly recalls and liability from trace contamination, several major producers found a third option. They began intentionally adding small amounts of sesame flour or seeds to their standard recipes.[3]
By making sesame an intentional ingredient, bakeries can simply print "Contains: Sesame" on the back of the bag. This practice technically complies with the letter of the FASTER Act, as the allergen is fully disclosed to the shopper. However, it completely subverts the spirit of the law, abruptly transforming previously safe staples—like the plain buns served at major fast-food drive-thrus—into off-limits hazards for the 1.6 million Americans allergic to the seed.[3][6]
The FDA has been highly critical of the practice. In public statements, the agency acknowledged that while adding sesame and labeling it does not violate the law, it creates an outcome the FDA strongly opposes. The agency has repeatedly urged manufacturers to follow its draft guidance on minimizing cross-contact rather than taking the easy way out.[1][3]
In public statements, the agency acknowledged that while adding sesame and labeling it does not violate the law, it creates an outcome the FDA strongly opposes.
The tension eventually escalated into direct enforcement action. In June 2024, the FDA sent a formal warning letter to Bimbo Bakeries USA—one of the largest bakery companies in the country—for intentionally adding sesame to its products and for listing sesame on labels of products that did not actually contain it, simply to cover potential cross-contact risks.[2]
In a response letter later revealed by watchdog groups, Bimbo Bakeries defended its approach. The company argued that it could not reliably control trace amounts of sesame across its manufacturing network, determining that adding it as an ingredient was the "most protective approach" to ensure allergic consumers were warned.[2][6]
The standoff highlights a fundamental flaw in the current U.S. allergen regulatory framework: it is entirely binary. Under current rules, an allergen is either intentionally present and declared, or it must be completely absent. There is no legally defined safe harbor for trace amounts of cross-contact.[5][7]
This zero-tolerance approach forces companies into a corner. If a bakery tests a batch of plain sourdough and finds a microscopic trace of sesame dust from a previous run, that entire batch is considered adulterated and subject to a costly public recall. Without a defined threshold of what constitutes a dangerous amount, companies over-label or intentionally bake the allergen right into the dough to shield themselves from liability.[4][7]
To solve this, the FDA is now exploring a systemic overhaul. In February 2026, the agency convened a major Virtual Public Meeting and Listening Session on Food Allergen Thresholds. The goal is to move away from the binary system and toward a risk-based threshold model.[1][5]
A threshold model relies on clinical data to determine the minimum amount of an allergen protein required to trigger a physical reaction. For example, international health organizations have established a reference dose of just 2 milligrams of total protein for sesame—a speck so small it is barely visible to the naked eye, but a concrete number that quality-control managers can actually test for.[4]
If the FDA adopts similar risk-based thresholds, it would give food manufacturers a practical, quantitative target. If a bakery can prove through rigorous testing that any potential sesame cross-contact falls well below the 2-milligram threshold, they would not be required to declare it as an ingredient or use a precautionary "may contain" label.[4][5]
This shift would align the United States with emerging global standards, such as those being adopted by the Codex Alimentarius Commission. More importantly, it would remove the legal incentive for companies to intentionally add allergens to safe foods, finally delivering on the FASTER Act's promise of expanding, rather than restricting, safe choices for allergic consumers.[4][7]
Jargon, explained
- Cross-contact
- The unintentional transfer of an allergen from a food containing that allergen to a food that does not, often occurring on shared manufacturing equipment.
- FASTER Act
- The Food Allergy Safety, Treatment, Education, and Research Act, a 2021 law that designated sesame as the ninth major food allergen in the United States.
- Reference Dose
- The specific amount of an allergen protein at which a small percentage of the allergic population would be expected to experience a reaction, used to establish safety thresholds.
- Precautionary Allergen Labeling (PAL)
- Voluntary advisory statements on food packaging, such as 'may contain,' used to warn consumers about potential cross-contact.
Sources
[1]U.S. Food and Drug AdministrationRegulatory AgenciesVirtual Public Meeting and Listening Session on Food Allergen Thresholds and Their Potential Applications
Read on U.S. Food and Drug Administration →
[2]Food Safety MagazineCommercial Food ManufacturersBimbo Bakeries Defends Intentionally Adding Sesame to Products in Response to FDA Warning Letter
Read on Food Safety Magazine →
[3]AP NewsCommercial Food ManufacturersFood manufacturers who deliberately add sesame to products and include the ingredient on labels are not violating a new federal food allergy law
Read on AP News →
[4]HygienaRegulatory AgenciesAllergen Uncertainty: Risk Assessment, Reference Doses and Codex Management Guidance
Read on Hygiena →
[5]Allergen BureauRegulatory AgenciesFDA Convened Virtual Public Meeting and Listening Session on Food Allergen Thresholds
Read on Allergen Bureau →
[6]Center for Science in the Public InterestAllergy Advocacy GroupsVirtual public meeting and listening session on food allergen thresholds and their potential applications
Read on Center for Science in the Public Interest →
[7]Factlen Editorial TeamRegulatory AgenciesSynthesis by Factlen editorial team
Read on Factlen Editorial Team →
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