Allergen labeling for US supplements: FALCPA and the sesame change

Supplements are food, and US food-allergen law applies to them in full. FALCPA defines the major allergens that must be declared, and the FASTER Act added sesame as the ninth — a change that caught many brands mid-formula. Allergen mislabeling is both a recall risk and a genuine safety issue.

FALCPA and the major allergens

The Food Allergen Labeling and Consumer Protection Act requires that major food allergens be clearly declared on labels. The original list covered milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. For supplements, this applies to ingredients, excipients, and processing aids derived from these sources.

Sesame as the ninth allergen

The FASTER Act added sesame as a major food allergen, with the requirement taking effect in 2023. Sesame must now be declared like the others. Notably, some manufacturers responded by intentionally adding sesame to products to simplify cross-contact management — a controversial workaround that highlights how seriously the requirement is taken.

How allergens must be declared

Major allergens are declared either within the ingredient list using the source name, or in a separate 'Contains' statement adjacent to the ingredient list. The source must be clear — 'whey (milk),' for example. For supplements, allergens hiding in capsule shells, flow agents, or flavorings are easy to miss and just as legally significant.

Cross-contact and the supply chain

Beyond intentional ingredients, allergen cross-contact in shared facilities is a real hazard. Knowing the allergen status of every ingredient — and every supplier's facility — is part of getting the declaration right. A formula's allergen profile is only as reliable as the supply-chain data behind it.

This is general information, not regulatory or legal advice. US requirements change and turn on specifics, so confirm the current rules with the FDA, FTC, or a qualified US regulatory expert before relying on them.

Where Lemoniq fits

Lemoniq holds each product as one structured formula — ingredients, amounts, specifications, sourcing, and the documentation behind them — and generates what a US dietary supplement label needs from that single source: the Supplement Facts panel, the claim and disclaimer wording, the records that cGMP expects, and the data to back overages, dating, and origin. Compliance becomes a property of the formula, not a pile of separate documents.

The takeaway

The US supplement model trades pre-market approval for full manufacturer responsibility, which means the work shifts onto documentation, accurate labeling, and defensible formulas. The brands that scale in the US are the ones whose single source-of-truth formula generates each label, specification, and record correctly — every time, across every product.

Lemoniq turns one formula into compliant, US-ready outputs — panel, claims, specs, and documentation — from a single source. We solve this exact problem. See how it works