Threshold Allergen Labeling: How Imminent Is It?

If you currently use “may contain” or a similar precautionary allergen statement on your products, I recommend that you conduct a complete review of your allergen program and your reasons for the use of the precautionary allergen labels (PALs).

I advise this for two reasons: First, to ensure that you are not using it as a pretext for what may be insufficient cleaning, sanitation or crossover work, and second, because FDA is considering the potential standardization of such labeling through the application of threshold values. While this wouldn’t remove the ability for manufacturers to use precautionary labeling, it would, in all likelihood, wrap standards and regulatory requirements around it.

The topic was the focus of a recent FDA public meeting and listening sessions, in which stakeholders, representing scientists, allergists, the food industry, patient advocates and consumers, presented both science and assessment on the use of thresholds in PALs. The sessions were intended to inform and prioritize any FDA action toward standardizing the warning statements, in such a way as to indicate whether an allergen is likely to be present from cross-contact above a set allergen threshold, rather than maintaining tolerance at zero. ED05 is the expert-recommended level and represents the threshold value at which just 5% of an allergic population would experience any adverse effects, and those would be mild to moderate and/or treatable.

However, labeling the potential presence of an allergen based on a threshold is completely counter to FDA’s current thinking: “There is no cure for food allergy; thus, to prevent allergic reactions, consumers must avoid the allergen(s) of concern.” Additionally, the use of precautionary labeling is currently applied at a manufacturer’s discretion, with some using the label as a sort of protective shield in case contact could have occurred (e.g., the unintentional inclusion of a sesame seed at a bakery).

But by also acknowledging that advances in allergen risk assessment are demonstrating that certain thresholds are not likely to elicit reactions in the vast majority of allergic persons, and by holding the listening sessions, FDA has shown that it is open to considering a change in its thinking and regulatory action.

And regulatory requirements are exactly what would be needed to make this work. Session speakers representing an array of stakeholders agreed that threshold labeling would work only if regulated consistently, and both the threshold values and the specific wording holding specific definitions, were applied. There also would need to be a great deal of industry education for that to happen.

Consumer education would be just as imperative. With total avoidance currently seen as the only safe option, shifting one’s thinking to the allowance of a safe dose — and relying on the accuracy of the labels — requires a great deal of faith in science and trust in the food industry.

Which brings me back to regulated standards. Precautionary labeling statements would be applicable to only unintentional inclusion of an allergen (allergenic ingredients would continue to be labeled as currently required); could not substitute for lack of allergen controls or sanitation (as is the case today); and would need to have a scientifically sound, consistent basis (such as the proposed ED05 threshold).

Given the intensity of educational and regulatory challenges, I wouldn’t expect to see a rule in the near future, but I do see it as positive that FDA is open to the discussion and consideration of change. So, to jump back to my original recommendation to conduct a complete review of your allergen program and your reasons for the use of PALs: Even with the unlikelihood of an imminent rule, the fact that the agency is looking in this direction shows, well, that the agency is looking in this direction! And that increases the likelihood that a “may contain” or “made in a facility” label on your product will have the inspector looking much more closely at your sanitation and allergen programs.

Precautionary allergen labels have their place in the food industry, but they should always be used with caution, not only to ensure you are in regulatory compliance, but to best serve allergic consumers by not unduly limiting their access to a variety of foods.