The FDA is moving toward defining allergen thresholds, providing science-based guidance on when unintended allergen exposure is unlikely to cause reactions in most allergic consumers and clarifying how brands can apply advisory labeling and risk assessments during a February 18 webcast.
Avoiding certain foods – especially milk, egg, crustacean, shellfish, peanuts, fish, soybeans, tree nuts, sesame and wheat – are critical for people with allergies, making accurate labeling a must. While voluntary allergen advisory statements (AAS) are used to warn consumers about potential cross-contact, there are currently no formal requirements for when or how to use them. This regulatory gap has left manufacturers uncertain about how much precaution is necessary.
Recently, the agency revisited certain products, especially as voluntary allergy statements such as “may contain” or “manufactured in a facility that also processes” confuse consumers. Last month, FDA issued a request for information (RFI) from industry stakeholders on gluten disclosure and how to address the regulatory gaps around non-wheat gluten.
Risk-based approaches across agencies
FDA guidance aligns with frameworks from EFSA and FAO/WHO, which combine exposure estimates, margins of safety and reference doses to assess allergen risk.
Thresholds are ingredient- and use-specific, ensuring that labeling exemptions or reduced precautionary statements are scientifically justified and safe.
For example, WHO and FAO reference dose peanut at 2 milligrams of peanut protein. As a practical example, the amount of peanut protein from cross-contact in spices added to pizza would be far below this 2 milligram threshold, explained Laura Shumow, executive director of the American Spice Trade Association.
Another example, mustard, in a 95th percentile consumption scenario for mustard-derived emulsifiers showed a margin of exposure of 29, meaning an allergic person would need to consume 29 times the maximum intake to be at risk, according to EFSA.
FDA thresholds provide a science-based reference
FDA allergen risk assessments indicate that low-level exposures are unlikely to trigger reactions in the vast majority of allergic consumers. Allergen levels set by FDA show the amount of accidental allergen exposure that is considered safe for the majority of people with food allergies.
According to the panelists, thresholds can support:
- Petitions for labeling exemptions
- Compliance and enforcement actions
- Development of AAS policies
- Guidance on allergen cross-contact controls
“Thresholds give manufacturers confidence that they can adequately implement controls to manage allergens, because they know what adequate means,” said Melanie Downs, associate professor of food science and technology, University of Nebraska-Lincoln during the panel.
Streamlining allergen management in manufacturing
In the past, food companies treated allergens like microbes when designing safety standards. This meant that the focus was on cleaning equipment, sometimes at the expense of other critical measures like label verification, ingredient controls and process checks that can help prevent allergen exposure.
Reference doses, or threshold doses, are science-backed levels of allergens that are considered unlikely to trigger an allergic reaction in the majority of people who have that allergy, according to Scott Hegenbart, manager of regulatory affairs, Conagra Brands.
In other words, if allergen residue stays below the reference dose, the risk of a reaction is extremely low.
These thresholds could reduce reliance on wet cleaning (cleaning equipment or surfaces using water, detergents and sanitizers). Wet cleaning can increase the risk of microbial growth like Salmonella for dry foods, like baked goods or powders, because moisture can breed bacteria if not dried properly, added Nathan Mirdamadi, global director of sanitation, Kerry.
With thresholds in place, manufacturers can determine which type of cleaning method to use that’s based on risk instead of aiming for zero allergen levels.
Sector-specific challenges: Baking and spices
Some industries face unique allergen control challenges. In baking, sesame cross-contact, for example, even with rigorous cleaning, may leave trace amounts, forcing recalls or overuse of precautionary labeling, said Rasma Zvaners, VP, government relations, American Bakers Association. Thresholds, Zvaners argued, would provide clear, actionable limits so bakers can manufacture both seeded and non-seeded products safely.
In spices, agricultural cross-contact results in trace allergen proteins, explained Shumow. Since spices are used in very small amounts, actual exposure is often far below reference doses. But, established thresholds would clarify these low-risk scenarios, allowing manufacturers to expand product options without increasing risk.
Benefits for brands and consumers
Allergen thresholds offer advantages for manufacturers by reducing the need for precautionary statements and minimizing recall risk that align with predictable, consistent regulatory compliance, according to the panelists.
Consumer communication also remains essential, added Matthew Greenhawt, chief medical officer, Asthma and Allergy Foundation of America. Thresholds make labeling more transparent, helping allergic consumers make informed choices.
FDA allergen thresholds signal a shift from zero-tolerance to a science-based, risk-driven framework. Brands can focus resources on controls that truly matter, maintain high safety standards, reduce unnecessary liability and provide clearer guidance for allergic consumers, according to the panelists.
FDA is accepting comments on the guidance at Regulations.gov for docket FDA-2026-N-1304 to determine next steps. Electronic comments must be submitted on or before May 19, 2026.
