Question 1

What is a Precautionary Allergen Label (PAL)?

Accepted Answer

A Precautionary Allergen Label (PAL) is a voluntary warning statement — such as "May Contain," "Made in a facility that also processes," or "Manufactured on shared equipment with" — that food companies add to packaging to alert consumers about the potential for cross-contamination with allergens. Unlike the required ingredient statement, PAL statements are entirely unregulated: there are no standards for when they must be used, what language is required, or what level of allergen risk they must reflect.

Question 2

Why isn't "May Contain" labeling regulated by the FDA?

Accepted Answer

Currently, the FDA does not require or regulate precautionary allergen statements. While the Food Allergen Labeling and Consumer Protection Act (FALCPA) mandates disclosure of the top nine allergens in ingredient lists, it does not address cross-contamination warnings. The FDA has been studying whether and how to regulate PAL, but no binding rules are yet in place — leaving food allergic consumers to navigate inconsistent, unreliable warnings.

Question 3

What is an ED05 (eliciting dose) and why does SFLA oppose it?

Accepted Answer

The food industry has advocated for the FDA to adopt ED05 as the basis for PAL regulation, meaning a product would only need a warning label if it contains enough allergen to trigger a reaction in 5% of food allergic people. SFLA opposes this because it would leave 1.6 million food allergic Americans — those who react at lower doses — without any warning on the label, exposing them to serious and potentially life-threatening risk.

Question 4

How many Americans are affected by food allergies?

Accepted Answer

Approximately 33 million Americans live with food allergies, including roughly 6 million children. Food allergies can cause reactions ranging from hives and digestive distress to anaphylaxis, a severe and potentially fatal reaction. For these individuals and their families, accurate and reliable food labeling is not a convenience — it is a matter of life and safety.

Question 5

What is SFLA asking the FDA to do?

Accepted Answer

The Safe Food Label Alliance, Inc. is urging the FDA to regulate Precautionary Allergen Labels in a way that protects all food allergic Americans — not just 95% of them. Specifically, SFLA advocates for a threshold standard that accounts for the most sensitive members of the allergic community, clear and consistent PAL language that consumers can understand and trust.

Protect All Food Allergic Americans with Mandatory Precautionary Allergen Labeling

KEY ISSUE: Regulating Precautionary Allergen Labels (PAL) — "May Contain" Warnings

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