New Estimates of ‘Safe’ Levels of Exposure to Peanut Protein for U.S. Population

Washington D.C.— Food allergies affect a significant number of children and adults in the U.S. and Canada. In an effort to avoid allergic responses, people with allergies and parents of children with allergies now have to rely on food labels that offer ambiguous precautions about the presence of the proteins causing the allergy in foodstuffs or processing facilities. The current labels do not reflect the minimal amounts of exposure that those with allergies could potentially tolerate in a product without a major reaction. Current labels, with statements like “may contain” or “was processed in a facility…” are generally not helpful to consumers managing allergies. New studies are being done to determine “safe” levels to improve labels and health. 

One of those studies was led by researchers at the University of Cincinnati and evaluated how much peanut protein those with allergies can tolerate, which could lead to more informative labels. The study was supported by the Institute for the Advancement of Food and Nutrition Sciences (IAFNS), a research nonprofit uniquely positioned to mobilize industry, government and academia to drive, fund and lead actionable research. IAFNS elevates food safety and nutrition sciences to advance public health. The organization was founded on the belief that collaboration and the inclusion of diverse perspectives is crucial to credible science that benefits the entire food and beverage ecosystem.

IAFNS supported this peer-reviewed study—the first of its kind to rigorously and transparently estimate doses of tolerable amounts of peanut protein—based on tests in U.S. patients. The scientists relied on established research protocols and what is called “double-blind placebo-controlled food challenges” conducted at multiple locations. In these challenges, each patient is exposed to increasing levels of peanut protein in a controlled clinical setting until the patient shows signs of an allergic reaction.

The researchers reviewed clinical trial data regarding the dose that caused a reaction. This allowed them to expand our understanding of doses that could cause a reaction in an allergic population. Their final dataset included 548 peanut protein challenges of 481 research subjects after accounting for responses to placebo protein. The scientists examined individual differences in response to allergens as well as differences across studies. Several sources of variability were considered, including variability between studies (not significant), and between individuals (significant). These individual differences in response are particularly important for establishing safe limits.

The University of Cincinnati-led team used a modeling approach that could account for the different levels of data organization (i.e., individuals and sites within a study) and explored the fit of alternative mathematical models. Scientists use these models to estimate what’s called an “eliciting dose” (or ED) to set safety limits on allergens.

For example, what’s called the ED01 would elicit an allergic response in 1 percent of those tested and was calculated to be 0.052 milligrams peanut protein. The ED05 would cause reactions in 5 percent of those tested and was calculated to be 0.49 milligrams peanut protein.

Developing science-based, informative labels for nut allergens has implications for food manufacturers and processors, consumers, government regulators and patients seeking to enhance management of food allergies.

The results advance public health and allergen management by increasing knowledge of the risk characteristics of this protein. The findings also promote public health as critical steps toward establishing more informative food labels as called for in a 2017 National Academies of Sciences report.

 

Collaborating institutions: University of Cincinnati, Stanford Medicine, The Emmes Company LLC, Bruce Allen-Independent Consultant, IAFNS