US allergen labeling protects you only if you know what it covers — and what it doesn’t. This page explains the rules that apply to packaged foods sold in the United States, the gaps to watch for, and the changes the FDA made in January 2025.
The 9 Major Food Allergens
The Food Allergen Labeling and Consumer Protection Act (FALCPA, 2004) and the FASTER Act (2021) define nine major food allergens: milk, egg, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame labeling became required on January 1, 2023. Some manufacturers responded by adding sesame to products rather than controlling cross-contact, so re-check labels on products you used to consider safe.
How Major Allergens Must Appear
- Either in the ingredient list, by a common name or in parentheses — for example "whey (milk)" — or in a "Contains" statement next to the ingredient list.
- The specific type must be named: the tree nut ("Contains: Almond", not just "tree nuts"), the species of fish (such as cod), and the species of crustacean (such as shrimp).
- The rule covers every ingredient, including flavorings, colorings and incidental additives. Hydrolyzed proteins must name their source (for example "hydrolyzed soy protein").
- Highly refined oils made from a major allergen are exempt. Cold-pressed, expeller-pressed and "gourmet" oils — including most peanut, tree-nut and sesame oils — still contain protein and are not exempt.
What Changed in January 2025
The FDA’s Food Allergen Labeling Guidance (Edition 5, January 2025) made several changes:
- Tree nuts: the list was narrowed to 12 — almond, black walnut, Brazil nut, California walnut, cashew, filbert/hazelnut, heartnut/Japanese walnut, macadamia nut/bush nut, pecan, pine nut, pistachio and walnut. Coconut, chestnut, shea, hickory, butternut and several others were removed.
- Removed nuts still appear by name in the ingredient list, but no longer in the "Contains" statement. If you are allergic to coconut or chestnut, for example, read the full ingredient list.
- Milk now includes milk from goats, sheep and other domesticated ruminants, and egg includes eggs from other birds such as duck and quail. These must be declared by species (for example "goat milk").
Labels You Cannot Rely On
- "May contain" and "processed in a facility" statements are voluntary and unregulated. A product without one can still have cross-contact. Contact the manufacturer when in doubt.
- "Free-from" claims such as "dairy-free", "nut-free" and "vegan" are not regulated allergen claims. FDA testing has found milk in products labeled dairy-free.
- "Gluten-free" is regulated for gluten (less than 20 parts per million) but does not mean wheat-free: gluten-free foods may contain wheat starch, which is labeled "wheat".
Foods and Products the Rules Don’t Fully Cover
- Meat, poultry and some egg products are regulated by the USDA (FSIS). Ingredients are listed, but a "Contains" statement is voluntary — read the ingredient list (for example, mortadella often contains pistachio).
- Alcoholic beverages are regulated by the TTB, where allergen labeling is voluntary. Ask the producer about liqueurs and flavored spirits.
- Restaurant, bakery-counter and other unpackaged foods are not labeled. Always ask about ingredients and preparation.
- Cosmetics and personal-care products use botanical (INCI) names, such as Prunus amygdalus dulcis (almond) or Sesamum indicum (sesame).
- Allergens that are not US "majors" — mollusks (clams, oysters, mussels, scallops, squid), mustard, celery, lupin, coconut and others — are listed by name in the ingredients but never flagged in a "Contains" statement. The EU and Canada require labeling of some of these, which matters for travel and imported foods.
- Imported foods must meet US rules, but labeling errors and recalls do happen.
Everyday Habits That Help
- Read the full label every time you buy a product — recipes and factories change.
- Check both the ingredient list and the "Contains" statement.
- Sign up for allergy recall alerts from the FDA or the USDA.
- When a label is unclear, contact the manufacturer before eating the food.
