Food Allergen Labeling: The Big 9 and What FALCPA Requires

US federal law requires clear labeling of these 9 major food allergens on all packaged food products:

1. Milk
2. Eggs
3. Fish (with species identified)
4. Crustacean shellfish (with species identified)
5. Tree nuts (with species identified — almonds, cashews, walnuts, etc.)
6. Peanuts
7. Wheat
8. Soybeans
9. Sesame (added January 1, 2023 by the FASTER Act)

These 9 allergens account for approximately 90% of serious food allergic reactions in the US. The remaining 10% are caused by other allergens (mustard, celery, lupin, mollusks, etc.) that are NOT required to be labeled in the US (though some are required in the EU and other countries).

FALCPA requires allergen declaration in one of two formats:

Format 1 — "Contains" statement: a separate statement at the end of the ingredient list: "Contains: milk, wheat, eggs." Simple, easy to scan.

Format 2 — Parenthetical in ingredient list: allergen declared next to the ingredient: "whey (milk), lecithin (soy), natural flavor (contains egg)."

Most manufacturers use Format 1 because it's easier for consumers to find and reduces liability. Both are equally legal.

Requirements:

• Must use the common name of the allergen, not the scientific or technical name. "Casein (milk)" not just "casein."
• Must identify the specific tree nut species, fish species, and crustacean shellfish species.
• Applies to all ingredients including sub-ingredients, processing aids, and incidental additives at any level.
• Applies to all food products regulated by FDA (not USDA-regulated meat/poultry, which has separate rules).

Statements like "may contain traces of peanuts," "made in a facility that processes tree nuts," or "manufactured on shared equipment with milk" are called Precautionary Allergen Labels (PAL). Key fact: these statements are entirely voluntary.

This creates a significant gap:

• Product A uses PAL: "may contain peanuts" — the manufacturer is being transparent about cross-contamination risk
• Product B does NOT use PAL — but is made on the same equipment. The manufacturer is choosing not to disclose.
• Both products have the same actual cross-contamination risk, but the labeling differs

There is no FDA standard for when PAL should be used. Each manufacturer sets their own threshold for disclosure. Some use PAL on virtually everything (low risk but legally conservative). Others never use PAL despite real cross-contamination risk.

For allergic consumers: the absence of a "may contain" statement does NOT mean the product is free from cross-contamination. It only means the manufacturer chose not to use advisory labeling.

1. Restaurants are not covered by FALCPA. Restaurants have no federal requirement to disclose allergens. Some states (Massachusetts, Rhode Island, Michigan, and others) have state-level restaurant allergen laws, but coverage is uneven.
2. USDA-regulated products have different rules. Meat, poultry, and egg products are regulated by USDA, not FDA. USDA has its own allergen labeling rules that are similar to FALCPA but not identical.
3. "May contain" is unregulated. No standard for when to use precautionary labeling or what threshold of cross-contamination triggers it.
4. Non-Big-9 allergens are not required. Mustard, celery, lupin, buckwheat, and mollusks — all significant allergens — are not required to be labeled in the US. The EU requires 14 allergens.
5. Highly refined oils are exempt. Highly refined soybean oil and peanut oil are exempt from allergen labeling because the refining process removes most protein. However, cold-pressed and unrefined oils must be labeled.
6. Alcoholic beverages have limited requirements. Wine, beer, and spirits are regulated by TTB (not FDA), with more limited allergen disclosure requirements.

1. Always read the full ingredient list + "Contains" statement. Don't rely on front-of-package claims. "Dairy-free" is not a regulated term and doesn't guarantee absence of milk proteins in some cases.
2. Check every time you buy. Manufacturers change formulations without notice. A product that was safe last month may have added a new ingredient this month.
3. Understand "may contain" limitations. The presence of PAL means real risk. The absence of PAL does NOT mean no risk. For severe allergies, contact the manufacturer directly to ask about shared equipment and cross-contamination controls.
4. Know the hidden names. Milk can be listed as casein, whey, lactalbumin, lactoglobulin, ghee. Wheat can be listed as durum, emmer, einkorn, kamut, spelt, semolina. Egg can be listed as albumin, globulin, lysozyme, mayonnaise, meringue.
5. Use manufacturer contact information. For severe allergies, call the manufacturer's consumer affairs line and ask specific questions about shared lines and allergen controls. Most major manufacturers have dedicated allergen management programs.
6. Carry epinephrine. Labeling is imperfect. Cross-contamination happens. For anyone with a history of anaphylaxis, carrying an EpiPen is the last line of defense.

Several regulatory changes are in discussion or development:

• Standardized PAL: FDA has been considering mandatory, standardized precautionary allergen labeling for years. A formal rulemaking would require manufacturers to use PAL when cross-contamination exceeds a defined threshold (likely based on clinical "eliciting dose" data). No timeline for completion.
• Additional allergens: advocacy groups have pushed for expanding the Big 9 to include mustard, celery, and lupin (already required in the EU). No legislation is currently pending.
• Restaurant labeling: state-level efforts are ongoing. Federal restaurant allergen labeling is unlikely in the near term.
• Enhanced enforcement: FDA has increased allergen-related recalls in recent years, suggesting tighter enforcement of existing FALCPA requirements.

Until these reforms happen, the burden remains on allergic consumers to read labels, ask questions, and maintain vigilance beyond what the law guarantees.