FALCPA allergen labeling: the 9 US major allergens (including sesame)

US food and supplement labels have to declare major allergens — and as of recent years, the list grew. Sesame became the ninth major allergen, catching out manufacturers who had built their labeling around eight. For supplements, where allergens hide in excipients and capsule materials, getting allergen declaration right under FALCPA is both a legal requirement and a genuine safety issue.

The law behind US allergen labeling

Allergen labeling in the US is governed primarily by FALCPA — the Food Allergen Labeling and Consumer Protection Act — as built on by later legislation. It requires that major food allergens be clearly declared on the labels of foods, including dietary supplements, so that allergic consumers can identify them.

The principle mirrors the EU's: if a major allergen is present, the consumer must be able to see it clearly.

The major allergens

FALCPA established a list of major allergens that must be declared. For years this was eight: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. More recently, sesame was added as the ninth major allergen, with its own effective date that required manufacturers to update labels.

That addition is a useful reminder that the allergen list is not fixed forever — and that a label built against an older list can quietly become non-compliant when the list changes.

How declaration works

FALCPA requires the major allergens present to be declared in a way the consumer understands — either within the ingredient list using the common name of the food source, or in a separate Contains statement. The food source has to be named clearly (for example, the specific tree nut), not hidden behind a technical term.

This is a labeling rule with a hard safety edge: a consumer with a severe allergy relies on it.

Why allergens hide in supplements

Supplements are especially prone to overlooked allergens, because so much arrives through ingredients that are not the headline actives. Excipients, carriers, capsule and softgel materials, flavours, and processing aids can all introduce a major allergen. A binder, a coating, a protein source, a gelatin shell — any can bring an allergen into the product.

This is why allergen checking cannot stop at the actives. It has to cover every component, down to the smallest excipient.

The difference from the EU list

Manufacturers who sell on both sides of the Atlantic need to remember that the US and EU allergen lists are not identical. The EU declares 14 allergens; the US declares its major allergens. There is overlap, but they are not the same, and a label compliant for one is not automatically compliant for the other. Each market's allergen declaration has to be checked against that market's list.

Because allergen lists and labeling rules can change and differ by market, confirm the current requirements for each market you sell into rather than relying on a general summary.

Why manual checking is risky

The failure mode is familiar and serious: an allergen enters through a minor ingredient, nobody flags it, and it does not reach the label correctly. With formulas containing many ingredients, each with its own allergen profile, manual cross-checking is exactly the kind of repetitive task where attention slips — and an allergen error is not a paperwork problem but a safety and recall risk.

Rolling allergens up from the formula

The robust approach is to attach an allergen profile to every ingredient and let the system roll those profiles up across the whole formula automatically — and to apply the right list for the market. When an allergen-bearing ingredient goes in, the allergen appears in the product's declaration without anyone having to remember it, and when the list changes, the data is updated rather than every label re-checked by hand.

The takeaway

FALCPA requires US labels to declare major allergens — now including sesame as the ninth — and the rule applies to supplements as much as foods. The danger is the allergen hiding in a minor ingredient, and the difference between the US and EU lists for those who sell in both. Rolling allergens up automatically from the formula, against the right market's list, removes the part of the process most prone to dangerous error.

Lemoniq attaches allergen data to every ingredient and rolls it up across the formula against each market's list, so your US allergen declaration always matches what is actually in the product. We solve this exact problem. See how it works