The use of precautionary allergen labeling (PAL) has long been at issue, with labels such as “may contain” being unregulated, unstandardized, misunderstood, and misused. Is there a way to better implement PALs to benefit consumers? Should the current voluntary use of such statements become regulation? If PAL use is to continue, how can it be standardized?
Such questions were at the root of FDA’s February virtual public meeting and listening sessions intended to provide and hear insights from various factions of the industry, allergen experts, advocates, and consumers on Food Allergen Thresholds and their Potential Applications. FDA’s current thinking on allergens is that “there is no cure for food allergy; thus, to prevent allergic reactions, consumers must avoid the allergen(s) of concern.” But given the advances in allergen risk assessment, demonstrating that certain low level dose exposures are not likely to elicit reactions in the most allergic persons, the agency is open to the possible applications of thresholds.
While the goal of the virtual sessions was to “help inform the FDA’s next steps, prioritize potential options, and advance our food allergen threshold approaches to benefit public health,” it quickly became evident that a vast array of challenges would need to be overcome before much such advancement could take place.What did achieve general agreed-upon clarity was that PALs should be regulated, standardized, and based on a set allergen threshold. But the specifics of its regulatory implementation, industry fulfillment, and consumer education were less clear.
Using Allergen Threshold Values in Precautionary Allergen Labeling
Food allergic reactions occur when the body’s immune system reacts to certain proteins in food, with reactions varying in severity from mild to severe or life-threatening symptoms. Although the sensitivity to the proteins also varies among those who are allergic, there is much consensus that PALs could be based on an allergen threshold value, defined by FDA as the value below which it is unlikely that a food allergic individual would experience an adverse effect.
The value most frequently cited in the meetings was the eliciting dose of 5% (ED05), which represents the total amount of an allergen protein predicted to trigger only objective, mild-to-moderate, treatable symptoms in 5% of individuals allergic to that food; with the other 95% experiencing no symptoms. While studies have found that up to 0.25% could experience anaphylaxis, the majority of these would resolve without treatment, and nearly all would respond to epinephrine, with no reports of fatalities.
Given the studies and statistics, it was conceded that the ED05 could be the reference dose by which a threshold value could be set for the use of a PAL statement. This means that a food product containing an unintentional, trace amount of an allergen below the established ED05 threshold would not require a precautionary allergen label. However, that does not come without challenges for both the industry and consumers.
Industry Challenges in Implementing Allergen Threshold Labeling
One of the most significant challenges for the industry is the education that will be needed to ensure consistent, harmonized use of a threshold/reference dose across the industry by suppliers as well as manufacturers.
The labeling of threshold values would also provide a challenge for the industry, as labs are used to detecting the existence or concentration of an allergen vs. the dose (that is, the total amount in milligrams) of an allergenic protein, upon which a threshold value would be based. A standard determination would also need to be made as to whether the label is to reflect the total amount in the container or in servings per container – or both. And there also will need to be appropriate assay kits available to and useable in a facility.Because of the standardization needed for these challenges, it is critical that a regulation be enacted that addresses all the potential variances. The regulation would also need to specify whether the facility can validate the dose itself (e.g., through internal testing and documentation) or if a third-party validation and/or certification would be required – a point which did not receive consensus from session participants.
Consumer Understanding and Challenges with Allergen Threshold Labeling
One key area of concern for consumers was the mindset shift that would be required of those who have food allergies, along with their providers and physicians. Following the long-held thinking of the FDA and experts, consumers have been told that the only prevention is complete avoidance of the allergen(s) of concern.
A change in thinking that most can tolerate the allergenic protein up to a certain level involves a complete shift in thinking and action. It is a shift that is difficult to make when the health and potential life of oneself or one’s family is at risk. It is a shift that will require massive education – of those who are allergic, their family and caregivers, and healthcare providers. And it is a shift that will require consumer trust in the industry’s sampling and labeling, particularly given the currently high number of undeclared allergen recalls.
Such a change would also require physician input to assist in determining the sensitivity of each allergic person to understand if they are in the 5% or 95% brackets, and standards by which that sensitivity is to be determined.
If all this were to be accomplished, the final rule should include a simple, standardize risk-based labeling system that can be understood at a glance by consumers and is mandated for the industry.
FDA has set no timeline for advancing food allergen threshold approaches, but has opened a comment period through May 19 for additional input.
Summary: The FDA is exploring whether allergen thresholds could help standardize precautionary allergen labeling (PAL) statements such as “may contain.” While a reference dose approach like ED05 could create clearer, risk-based labeling standards, it emphasizes the importance of industry and consumer education to support safe and effective implementation, addressing the challenges of testing methods and understanding.
