Precautionary Allergen Labeling (PAL): What does it mean?

People with food allergies need to know what is in the food they buy so they can know if it’s safe to eat – to avoid potentially severe reactions. This is why we have food allergen labeling laws. In the U.S., these laws fall under the Food Allergen Labeling and Consumer Protection Act (FALCPA) and the newly passed Food Allergy Safety, Treatment, Education and Research (FASTER) Act of 2021. Together, these laws lay out the required labeling of the top nine food allergens in America: milk, eggs, peanuts, tree nuts, crustacean shellfish, fish, wheat, soy, and sesame. In this article, we’ll take a look at what the requirements are for disclosing these allergens on labels in the U.S.

According to the laws, these nine foods, when used as intentional ingredients in food products must be labeled in plain English. Manufacturers have a couple of choices about how they want to list the items on the labels and may choose to include them in the ingredients list by their common name or in parentheses following their scientific name in this list. They may instead or also choose to include them after the ingredients in a contains statement (e.g., Contains: Peanuts). This makes finding these commonly allergenic foods easier for those with food allergies to the indicated foods. Foods not included on the top nine list are not subject to FALCPA.

But what about when there’s the chance that one of these potential allergens becomes an unintentional ingredient? FALCPA requires that the risk of cross contact be minimized. However, there are situations where manufacturers will be processing products that contain none of the top nine allergens and also those that contain one or more. Situations may include packaging or processing products with and without allergens in the same building, in the same room, or on the same lines. Ideally, manufacturers plan their product runs in a way that minimizes the risk of cross-contact by processing the items that don’t contain allergen first and by completing a thorough clean between each product, as well as performing appropriate testing to ensure the allergen(s) are not present where they aren’t wanted. But the risk of cross-contact is seldom absolute zero, so manufacturers have the discretion to utilize precautionary allergen labeling (PAL) to indicate potential risk. However, FALCPA does not require that manufacturers use PAL or set out specific language to describe potential risk to consumers with food allergies. Instead, manufacturers use their own internal decision making tools and verbiage to communicate this to their customers.

In a cross-sectional survey that included responses from 3,008 food allergy stakeholders, it used descriptive statistics and associations from logistic regressions to assess respondents’ knowledge of PAL policy, shopping habits, and preferences around PAL. Less than one quarter of respondents (24.2%) could accurately answer four questions about PAL. Most of the respondents however were assigning value to differently phrased PAL on labels and making purchasing decisions accordingly, in spite of the fact that this language is not regulated and that the actual risk is difficult to quantify based on the phrases used. These stakeholders indicated that their top choices for how manufacturers can communicate risk would be “not suitable for people with ‘blank’ allergy” and “may contain”.

In a previous interview with Kevin Boyd from Hershey’s laid out some of the precautions they take and how they decide what and how to share this information with their customers. Whatever language is used, most in the food allergy community agree that using consistent language that communicates true risk through PAL would be most helpful for those with food allergies. Having consistent language and agreed upon criteria for their use might also be helpful for manufacturers and, at the very least, would significantly increase trust in their manufacturing processes by the food allergy community.