Health Claims on Functional Foods — Global Guide

The FDA operates a three-tier system for food and supplement health claims. Tier 1 — Authorised Health Claims: these are pre-approved by FDA and backed by 'significant scientific agreement' (SSA) — e.g. 'Calcium may reduce the risk of osteoporosis'. A full list is in 21 CFR Part 101.72-101.83. Very few claims qualify. Tier 2 — Qualified Health Claims: backed by emerging but not conclusive evidence — FDA requires a specific disclaimer ('FDA has concluded that the evidence supporting this claim is not conclusive'). Tier 3 — Structure/Function Claims: no FDA pre-approval required, but you must notify FDA within 30 days of first use, have substantiation on file, and use the mandatory disclaimer 'This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.' Structure/function claims are the primary tool for supplement brands in the US.

In the EU, health claims are governed by Regulation (EC) No 1924/2006. All permitted health claims are listed in the EU Register of Nutrition and Health Claims — a publicly searchable database. There are three categories: Nutrition Claims (e.g. 'low fat', 'high fibre' — defined thresholds in Annex to the Regulation), General Function Claims (Article 13 — authorised by EFSA, e.g. 'Vitamin C contributes to the normal function of the immune system'), and Disease Risk Reduction Claims (Article 14 — very rarely authorised, very high evidentiary bar). Key rule: only claims in the EU Register are permitted — using a claim not in the Register is illegal. The Register is searchable at ec.europa.eu/food/safety/labelling_nutrition/claims/register. Many ingredients popular in the US functional food market (adaptogens, nootropics, many botanicals) have no authorised EU claims and cannot make benefit statements in EU marketing.

Post-Brexit, the UK maintains the EU's authorised health claims list as a retained standard — so claims authorised under EU Regulation 1924/2006 before Brexit are permitted in the UK. The Food Standards Agency (FSA) and Food Standards Scotland (FSS) now manage the UK health claims register. New health claims in the UK: the UK is developing its own process for new claim applications, which will diverge from the EU process over time. For now, the practical guidance is: if a claim is in the EU Register and was valid before 31 December 2020, it is valid in the UK. New EFSA authorisations post-Brexit do not automatically apply to the UK. The UK also retained a category of 'disease risk reduction claims' following EU authorisations. Brands expanding from EU to UK (or vice versa) should cross-reference both registers to ensure claims used in one market are permitted in the other.

Australia's food health claims framework under Standard 1.2.7 of the Food Standards Code uses a permitted list approach — similar in structure to the EU but with different claims. 'Nutrition content claims' (high calcium, low sodium, source of fibre) use defined thresholds in Schedule 4. 'Health claims' are either general level (from the approved Schedule 4 list — e.g. 'Calcium is good for bones and teeth') or high level (disease risk reduction — these require prior FSANZ approval and must be in Schedule 4). Unlike the EU and US, Australia does not have a direct equivalent of structure/function claims for conventional food — these are more appropriate for products sold as dietary supplements under a TGA Listed Medicines framework. The FSANZ nutrient profiling score also applies — only foods that pass a nutrient profile test can make health claims at all, regardless of the specific claim sought.

For brands selling functional foods or supplements across multiple markets, a practical claims harmonisation strategy: (1) Start with the most restrictive market — typically the EU. Determine which claims have EFSA authorisation and build those claims as your global base layer. (2) Add US-specific structure/function claims for the US market only — with the mandatory disclaimer. (3) For Australia, check Schedule 4 equivalents for any EU claims you're using. (4) Build your scientific substantiation library: a dossier of studies supporting each claim you make, by market. FDA inspectors, EU authorities, and Australian FSANZ can request substantiation at any time. (5) Don't make the same claim in different markets without checking jurisdiction-specific permission — a claim legal in the US may be illegal in the EU and vice versa, and a multi-market e-commerce brand needs geo-targeted claim language on its website.