Allergen labeling compliance for food and supplement brands is governed by two federal statutes: the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021. Together, they require mandatory declaration of nine major food allergens on every FDA-regulated packaged food label — with no de minimis threshold, no exemptions for incidental additives, and no protection from declaring an allergen just because it's a sub-ingredient in a compound ingredient.
The Nine Major Allergens
As of January 1, 2023, the following are the nine major food allergens under U.S. law:
Milk
Eggs
Fish (must specify species: e.g., "fish (salmon)")
Shellfish (must specify species: e.g., "shellfish (shrimp)")
Tree nuts (must specify type: e.g., "tree nuts (almonds, cashews)")
Wheat
Peanuts
Soybeans
Sesame — added by the FASTER Act, mandatory as of January 1, 2023
Each of these allergens must be declared whenever it is present as an ingredient, a component of an ingredient (sub-ingredient), a component of a flavoring, coloring, incidental additive, or any other component of the food.
How Allergen Declaration Works
Under FALCPA, the major food allergen must be declared in one of two ways:
Option 1: Parenthetical in the ingredient list — the common or usual name of the allergen source is placed in parentheses after the ingredient name. Example: "casein (milk)" or "lecithin (soy)" or "tahini (sesame)."
Option 2: "Contains:" statement — a separate statement following the ingredient list that identifies all the major allergens in the product. Example: "Contains: milk, soy, wheat, sesame."
Important: if a "Contains:" statement is used, it must be complete. A partial "Contains:" statement that identifies some but not all allergens in the product is a violation — it creates a false sense of security for consumers who check the "Contains:" line without reading the full ingredient list.
Both methods can be used together, and many brands use both for maximum clarity. Using only one is sufficient for compliance, but the "Contains:" statement is only safe if it's comprehensive.
Sesame: The New Requirement That's Still Catching Brands
Sesame's addition to the major allergen list under the FASTER Act took effect January 1, 2023. Three years later, sesame-related undeclared allergen recalls continue. The reason: sesame is pervasive in ingredient systems that were never reviewed for it, because sesame didn't need to be called out before.
The most common sources of undeclared sesame in CPG products:
Natural flavors and artificial flavors: Flavor houses use sesame oil and sesame-derived compounds as flavor carriers and enhancers. A "natural flavors" declaration in the ingredient list doesn't exempt a brand from disclosing a sesame-derived component. FDA issued guidance clarifying that sesame must be declared by name even when present only as a component of a flavoring system.
Spice blends: Middle Eastern and Asian spice blends, za'atar, tahini-based seasonings, and many proprietary seasoning systems contain sesame. If a compound ingredient listed on your label as "spices" or "seasoning blend" contains sesame, the allergen must be declared.
Baked goods and snack coatings: Sesame seeds and sesame paste are common in bakery formulations. If your contract manufacturer added a sesame-seed topping or a sesame oil coating that wasn't in your original specification, you have an undeclared allergen.
Processing aids and release agents: Some equipment lubricants and non-stick coatings used in food manufacturing are sesame-oil based. These are subject to allergen declaration requirements when they are functional in the finished food.
The operational implication: every ingredient in every product needs to be reviewed against all nine allergens — not just the eight that were covered before 2023. For brands with legacy formulations and supplier relationships, that review is not trivial.
Sub-Ingredients and Compound Ingredients
The most common operational source of undeclared allergen violations is compound ingredients: ingredients that themselves contain multiple components. Under 21 CFR 101.4(b)(2), a compound ingredient may be listed by its common name with its components declared parenthetically, or each component may be listed individually in the main ingredient list.
The allergen obligation does not depend on which format is used. If any component of a compound ingredient is an allergen source — regardless of how far down the formulation tree it appears — that allergen must be declared on the label.
A barbecue sauce containing soy-based Worcestershire sauce. A protein bar with a chocolate coating that contains milk. A seasoning blend with a tahini-based flavor system that contains sesame. All three require allergen declarations. Whether the brand knew about the sub-ingredient allergen is not a defense — the obligation to declare runs with the presence of the allergen in the food.
"May Contain" Statements: What They Mean and What They Don't
Advisory "may contain" statements — "may contain traces of peanuts," "manufactured in a facility that also processes tree nuts" — are voluntary under federal law. FALCPA does not require them, and they do not substitute for a required allergen declaration.
A "may contain" statement is appropriate when the allergen's presence is possible due to cross-contact during manufacturing — shared equipment, shared production lines, inadequate changeover controls — but the allergen is not an ingredient. It is not appropriate as a substitute for a "Contains:" statement when the allergen is actually in the product.
Using a "may contain" advisory in place of a required allergen declaration is a misbranding violation. A brand that knows an allergen is present in a product cannot substitute "may contain" language for the mandatory declaration.
The legal and practical risk of over-relying on "may contain" advisories: they are not independently verified by FDA, they carry no regulatory force, and they expose brands to consumer protection litigation if the advisory is used to obscure a known allergen presence rather than a genuinely uncertain one.
Building an Allergen Control Process
Allergen labeling failures are almost always process failures, not knowledge failures. The brands that avoid allergen recalls have systems in place at each point where an allergen can enter the product.
Ingredient specification review
Every ingredient — including compound ingredients, flavoring systems, and processing aids — should have a current specification that identifies all allergen sources at the sub-ingredient level. Specifications should be reviewed when a new ingredient is onboarded, when a supplier announces a formulation change, and on a periodic basis (at minimum annually) to catch changes that weren't communicated directly.
Reformulation triggers
Any reformulation — by your team or by a supplier — should automatically trigger an allergen review. The most dangerous scenario is a supplier change that doesn't reach your regulatory team: the reformulated ingredient goes into production, the label stays the same, and the allergen declaration is wrong before anyone notices.
Manufacturing facility review
Contract manufacturers and co-packers run multiple products on shared equipment. The allergen cleaning and changeover procedures between runs determine whether cross-contact is a real risk. Understanding what else runs on your production line, and what controls are in place, is part of allergen compliance — not just a quality concern.
Label verification against formulation, not just against previous labels
A label that was compliant two years ago may not be compliant today if any ingredient changed. Label compliance review should be conducted against current formulation documentation, not against a previous label version.
Allergen Compliance Is Not Static
The regulatory surface for allergen labeling will continue to expand. States are exploring additional allergen labeling requirements. FDA's ongoing review of food safety data may add additional allergens in the future. And the operational challenge of tracing allergens through increasingly complex ingredient supply chains is only growing.
Truli's AI compliance platform reviews ingredient lists and formulation data for all nine major allergens — tracing sub-ingredients through compound ingredients and flagging allergen sources that may be buried in flavoring systems or supplier specifications. When formulations change, Truli flags which labels need to be reviewed. Book a demo to see how Truli handles allergen labeling compliance for food and supplement brands.
