FALCPA allergen labeling: the major US allergens (including sesame)

Allergen labeling is one of the few areas where a single mistake can put a consumer in danger and a manufacturer into a recall. In the US, the rules are defined by FALCPA — and the list grew recently with the addition of sesame. For supplement makers, the risk is the same as in food: an allergen slips in through a minor ingredient and does not make it onto the label. Here is what to lock down.

The law behind US allergen labeling

US allergen labeling is governed by the Food Allergen Labeling and Consumer Protection Act (FALCPA), which applies to foods — a category that includes dietary supplements. It defines a set of major food allergens that must be clearly declared when present, and sets rules for how that declaration is made.

The principle is straightforward: if a major allergen is in the product, the label must make it unmistakable to the consumer.

The major allergens — now nine

FALCPA originally defined eight major allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. Sesame was subsequently added as a major allergen, bringing the list to nine and requiring it to be declared like the others.

That sesame change is recent enough that some older labels and supplier documents predate it — a reason to confirm that allergen data reflects the current list rather than the historical eight.

How declaration works

When a major allergen is present, it must be declared in a way the consumer can recognise — either within the ingredient list using the food source name, or in a separate "contains" statement. The food source has to be identified in plain terms, so a consumer with an allergy can spot it without specialist knowledge.

Getting the mechanics right — the correct source names, the placement — is part of compliance, not an afterthought.

Why allergens hide in supplements

Supplements are especially prone to overlooked allergens because so much sits in the supporting cast. An allergen can enter through an excipient, a carrier, a flavour, a protein source, a capsule or coating component — not just the headline active.

A flowing agent derived from a major allergen, a flavour carrying one, a protein ingredient — any of these can introduce a declarable allergen. This is why allergen checking has to cover every component of the formula, down to the smallest excipient, not just the actives.

Cross-contact and precautionary labeling

Separate from allergens deliberately in the formula is the question of cross-contact from shared equipment or facilities. Advisory or precautionary statements address this, and they are their own area of judgement and good manufacturing practice — distinct from the mandatory declaration of allergens that are actually ingredients.

Why manual checking is risky

The failure mode is consistent: an allergen enters through a minor ingredient, nobody flags it, and it does not reach the label correctly. With formulas containing dozens of ingredients, each with its own allergen profile, manual cross-checking is exactly the kind of repetitive task where attention slips — and the consequences here are safety and recall, not just paperwork.

Because allergen requirements are detailed and the list has changed, confirm the current FALCPA requirements for your products rather than relying on a general summary.

Rolling allergens up from the formula

The robust approach is to attach an allergen profile to every ingredient — active, excipient, flavour, capsule component — and let the system roll those profiles up across the whole formula automatically. When an allergen-bearing ingredient goes in, the allergen appears in the product's declaration without anyone having to remember it.

The formula composition drives the allergen declaration directly, so the two cannot drift apart — and a change to the allergen list is handled by updating the data, not re-checking every label by hand.

The takeaway

FALCPA requires the major US allergens — now nine, with sesame added — to be clearly declared on supplements as on foods. The danger is not knowing the list; it is missing an allergen that entered through a minor ingredient. Automatic roll-up from ingredient to declaration removes the part of the process most prone to the error that leads to recalls.

Lemoniq attaches allergen data to every ingredient and rolls it up across the formula automatically, so the declaration always matches what is actually in the product — current allergen list included. We solve this exact problem. See how it works