Guide
FALCPA allergen labeling: what the 2004 Act actually requires
FALCPA requires packaged FDA foods to declare the major food allergens using their common names — either inside the ingredients list or in a Contains statement immediately after it. It does not require “may contain” warnings, and it does not cover every food that can cause a reaction.
Reviewed against official guidance.SourcesNot legal advice.
The short answer
FALCPA requires packaged FDA foods to declare the major food allergens using their common names — either inside the ingredients list or in a Contains statement immediately after it. It does not require “may contain” warnings, and it does not cover every food that can cause a reaction.
Where this shows up in a real kitchen
Before 2006, a customer could see “whey” without seeing “milk”. FALCPA closed that gap for a defined list of major allergens. It applies to FDA-regulated packaged foods, including conventional foods, dietary supplements, and infant formula labeling in relevant parts. It does not replace Nutrition Facts, and it does not apply in the same way to raw agricultural commodities or to restaurant plates.
The US rule
The Act names milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat and soybeans. The FASTER Act later added sesame. You must use the allergen’s common name: “flour (wheat)”, not only “flour”; “whey (milk)”; “tahini (sesame)”. Fish and Crustacean shellfish and tree nuts must be named by species or nut type — “fish” or “nuts” is not enough. FDA’s FALCPA page is the primary explainer.
How to apply it
For each ingredient, ask whether a major allergen is in it, even if the supplier used a technical name. Put the common name in parentheses after the ingredient, or collect them in a Contains line that matches the list. Do not list an allergen in Contains that is absent from the recipe. Do not hide sesame under “spices” or “natural flavors” if it is an ingredient.
- Pull the current specification for every ingredient, not last year’s.
- Map technical names (casein, albumin, lecithin, tahini, miso) to major allergen names.
- Name fish, shellfish and tree nuts by type whenever they are ingredients.
- Choose either parenthetical declarations, a Contains statement, or both — then proof they agree.
Worked example
A jar of satay sauce lists “peanut butter, coconut milk, soy sauce (soybeans, wheat), brown sugar, lime, garlic, chili”. Contains: peanut, soy, wheat. Coconut is labeled as a tree nut by FDA for allergen purposes, so many labels also declare coconut. Anchovy is not in this recipe — do not copy a generic Thai-sauce Contains line that names fish.
Checks that belong on this pack
| Check | Why it matters |
|---|---|
| Whey, casein and lactose-free milk still mean milk | FALCPA is about the source allergen, not whether someone can digest lactose. |
| Soy lecithin and soy sauce both declare soy | Highly refined soybean oil is treated differently; lecithin is not that exemption. |
| “Spices” never hides sesame | Sesame as an ingredient must be named. A spice blend that contains sesame is not a loophole. |
| Contains line sits right after ingredients | FALCPA puts the Contains statement immediately following the ingredients list, not on the front as decoration. |
Declaring “nuts” instead of the nut
Tree nuts must be named: almond, pecan, walnut, cashew, pistachio, hazelnut, Brazil nut, macadamia, coconut where it applies. A single word “nuts” does not meet FALCPA for tree nuts.
What LabelClear can and cannot print
Use the generator to emphasise allergen names in the ingredients line, then add a Contains statement that matches. FALCPA is the US rule; the UK 14-list is not a substitute.
Questions
Does FALCPA require bold type?
Are molluscs covered?
Does it apply to alcohol?
Official sources
Everything on this page traces back to these. Where they and we disagree, they are right — tell us and we'll fix it.
- Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)U.S. Food and Drug Administration
- Food allergiesU.S. Food and Drug Administration
- Food Allergy Safety, Treatment, Education, and Research Act of 2021U.S. Food and Drug Administration
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