Food Allergen Risks Could Warrant Exposure Analysis
Authored by: Derek Drechsel, PhD, CIH, DABT
In early 2026, the Food and Drug Administration (FDA)’s Public Meeting on Food Allergen Thresholds signaled a meaningful evolution in the national conversation on managing an issue that impacts an estimated 33 million individuals in the US. Current regulations under the Food Allergen Labeling Consumer Protection Act require specific labeling of foods containing one of nine major food allergens. Foods may also contain advisory statements to address potential cross-contamination issues such “may contain [allergen]” or “produced in a facility that also uses [allergen].”
However, inconsistencies in the use of these voluntary labels can create confusion and limit food choices for allergic consumers. As a result, current management strategies remain hazard-based, with individuals practicing avoidance of relevant food allergens.
Previously addressed by the FDA in 2006, the revised approach to allergen management lies in the growing scientific evidence that food allergies are dose-dependent; an individual must consume a sufficient amount of an allergen to elicit an adverse effect. This represents a significant shift from hazard-based to risk-based allergen management systems.
A critical element in moving to a risk-based approach is consideration of exposure, or the amount of allergen one is exposed to. The amount of allergen present in a food, along with information on the amount (e.g., small vs. large portions) and frequency (e.g., single vs. repeated servings) of food consumption is critical to understanding how much of an allergen someone may be exposed to, and determining potential risks.
While new FDA regulations are not yet proposed, this revised approach will have significant impacts on food labeling and how cross-contamination issues are handled in food production and product recall decisions.
Roux’s Human Health Risk Assessment (HHRA) team of toxicologists, industrial hygienists, epidemiologists, and human health risk assessors has experience in conducting comprehensive exposure analysis to evaluate risk posed by food allergens. Our services include the following topics:
- Dose reconstruction/exposure modeling
- Evaluation and modeling of exposure from product use
- Evaluation of consumer products (FDA, CPSC, Cal Prop 65)
- Regulatory basis for health-based standards
- Risk communication to non-technical audiences
- Assessment of potential health risk from emerging contaminants
Please contact our experts using the form below if you would like further explanation of FDA’s meeting, evaluation of potential health risks associated with allergens or other chemicals, or information regarding Roux’s HHRA services.
