Supplement Health Claims: EU Authorised vs US Structure/Function
By Suplify Team · · 7 min read · 12 sources
Short answer
Supplement health claims are statements linking a product or nutrient to a health effect. In the EU, you use wording authorised under Regulation (EC) No 1924/2006 and listed in the EU register. In the US, structure/function claims are not pre-approved but need substantiation, an FDA notification and a fixed disclaimer. Treat-or-cure claims are off-limits.
Claims are a common source of trouble for new supplement brands. A product page says one word too many, and the claim drifts from "supports" to "fixes". This guide explains the two systems you are most likely to meet: the EU register of authorised health claims and US structure/function claims.
This is general information, not legal advice. Check your final copy with a qualified regulatory adviser.
What counts as a supplement health claim
A health claim is any statement that links a food, or something in it, to health. That includes your label, your product page, your ads and even your brand name.
The EU rules cover claims made in commercial communications, whether in the labelling, presentation or advertising of foods delivered to the final consumer.[1] They also apply to trade marks and other brand names which may be construed as nutrition or health claims.[1] So a name that promises an effect can be treated like a claim. If you are still picking a name, read how to name a supplement brand with this in mind.
The US uses different language. There, the common route for supplements is the structure/function claim. The two systems share a goal of honest claims but differ in process.
One rule of thumb works in both markets: claims to treat or cure disease are off-limits for your copy. In the EU, disease risk reduction claims exist, but they need specific authorisation under Article 14.[2]
The EU system: a list of authorised claims
The EU framework is Regulation (EC) No 1924/2006 on nutrition and health claims made on foods.[1] The Regulation started to apply on 1 July 2007.[3] Its aim is that any claim on a food's labelling, presentation or advertising is clear, accurate and based on scientific evidence.[3]
The key idea is simple. The register lists authorised health claims that can be used by all food business operators, provided they comply with the claim's particular conditions of use.[2] It also lists the rejected health claims.[2] Nutrition and health claims shall be based on and substantiated by generally accepted scientific data.[1] A food business operator making a nutrition or health claim shall justify the use of the claim.[1]
The EU register
The Commission keeps a public EU Register of Nutrition and Health Claims.[3] It shows permitted nutrition claims and their conditions of use, authorised health claims with their conditions and restrictions, and non-authorised health claims with the reasons they were rejected.[4] The Commission describes the register as being for information only.[4] So treat it as your starting reference, then read the legal act behind each claim.
Two practical points matter here:
- Use the wording as authorised. An example claim the Commission gives is "Vitamin D is needed for the normal growth and development of bone in children".[3]
- Meet the conditions of use. For instance, one condition reads that the claim may be used only for food which is at least a source of copper as referred to in the claim SOURCE OF.[5] Conditions vary per claim. Some, like this one, require a minimum nutrient level, so check your formula against them.
Mandatory extra information
Authorisation is not the end. Health claims shall only be permitted if the labelling includes a statement on the importance of a varied and balanced diet and a healthy lifestyle, plus the quantity of the food and pattern of consumption needed to obtain the claimed effect.[6] If no labelling exists, this goes in the presentation and advertising.[6]
Why exact wording matters
A good illustration comes from an EFSA scientific opinion on vitamin C. According to the applicant, vitamin C "helps to support a healthy immune system".[7] EFSA said the following wording reflects the scientific evidence: "Vitamin C contributes to the normal function of the immune system."[7] In short, EFSA chose wording that reflects the evidence. That precise wording is the version to copy, not a looser paraphrase.
The US system: structure/function claims plus a disclaimer
In the US, the Dietary Supplement Health and Education Act of 1994 (DSHEA) set special requirements for structure/function claims, claims of general well-being and claims related to a nutrient deficiency disease.[8]
Structure/function claims may describe the role of a nutrient or dietary ingredient. The FDA gives examples such as "calcium builds strong bones".[9] They may also describe how an ingredient acts to maintain such structure or function, for example "fiber maintains bowel regularity" or "antioxidants maintain cell integrity".[9]
What you must do
These claims are not pre-approved by FDA.[8] But the manufacturer must have substantiation that the claim is truthful and not misleading, and must notify FDA with the text of the claim no later than 30 days after marketing the product with the claim.[8]
The claim also needs the DSHEA disclaimer, prominently displayed and in boldface type: "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."[10]
The FDA's labeling guide sets firm rules on that disclaimer:
- You may not modify the wording of these disclaimers.[11]
- Place it immediately adjacent to the claim with no intervening material, or elsewhere on the same panel or page that bears the statement.[11]
- Use boldface type in a type size no smaller than one-sixteenth (1/16) inch.[11]
The FDA has also said it intends to exercise enforcement discretion regarding the requirement for the disclaimer to appear on each panel of a label where a 403(r)(6) claim appears.[12] That is narrow. It does not remove the disclaimer itself.
EU vs US side by side
| Question | EU (Reg. 1924/2006) | US (DSHEA structure/function) |
|---|---|---|
| Pre-approval needed? | Use claims listed as authorised in the register[2] | No, not pre-approved by FDA[8] |
| Wording | Authorised wording and conditions of use[2] | Your own wording, if substantiated[8] |
| Extra text | Balanced diet statement and consumption pattern[6] | Fixed DSHEA disclaimer[10] |
| Notification | Not covered in this guide | Notify FDA within 30 days of marketing[8] |
| Disease-related claims | Risk reduction claims need separate authorisation under Art. 14[2] | Disclaimer states product is not intended to treat or cure disease[10] |
The big takeaway: the EU is a menu you choose from. The US is a framework you write within.
Allowed vs risky wording: examples
The allowed column uses wording shown in official sources. The risky column is our own illustration of the kind of drift to avoid. It is not a full list.
| Market | Allowed-style wording | Risky wording |
|---|---|---|
| EU | "Vitamin C contributes to the normal function of the immune system."[7] | "Boosts immunity" or "stops colds" |
| EU | "Vitamin D is needed for the normal growth and development of bone in children"[3] | "Prevents weak bones" |
| US | "calcium builds strong bones" plus disclaimer[9] | "Treats osteoporosis" |
| US | "fiber maintains bowel regularity" plus disclaimer[9] | "Cures constipation" |
A quick self-check before you publish any line:
- Does it name a disease or symptom? Remove it.
- In the EU, can you find the claim in the register with matching conditions?
- Does your dose meet the condition of use?
- In the US, is the disclaimer present, unchanged and bold?
- Does your brand name or product name imply a claim on its own?
How Suplify handles claims in your store
Claims live everywhere: product pages, ads, emails and reviews you quote. That is why Suplify builds claim checks into the store, not just the label.
In Suplify, shopper-facing supplement copy is checked against the EU register of authorised health claims. Disease and cure wording is blocked. US stores get structure/function phrasing plus the FDA disclaimer. This is a guardrail, not a guarantee of compliance. You still own your final copy.
Email is an easy place to forget. In Suplify, every store runs lifecycle email flows automatically: welcome, abandoned cart, browse, post-purchase, replenishment and win-back. Each of those emails is marketing, so keep the same claim discipline there. Our guide to email flows for supplement brands covers what each flow should say.
Claims also shape your product choice. Some ingredients have clear authorised wording; others have little you can say. Check the claim before you pick a niche. The magnesium brand guide shows how this works for one ingredient.
Common mistakes first-time founders make
- Paraphrasing an EU claim. Making it punchier can change its meaning.
- Forgetting ads and social posts. The EU rules reach advertising, not just the pack.[1]
- Editing the US disclaimer. You may not modify the wording.[11]
- Ignoring conditions of use. A claim tied to a "source of" condition needs enough of the nutrient.[5]
- Copying competitors. Their wording may not be compliant either.
For the full label picture beyond claims, see our supplement label requirements checklist.
Next steps
Start with the product, then the claim, then the copy. If you are new, the step-by-step guide to starting a supplement brand walks you through the order. To understand how formulas and labels work when you do not make the product yourself, read the private label supplements beginner guide.
When you are ready to launch, Suplify builds your store in about 8 minutes, with no inventory and claim checks built in. It is $49/month on one plan, plus a 0.85% platform fee per order. See Suplify pricing for details, and run your numbers in the profit calculator first.
Frequently asked questions
What is the difference between a health claim and a structure/function claim?
In the EU, authorised health claims are listed in the EU register with their conditions of use.[4] In the US, a structure/function claim describes the role of a nutrient, like "calcium builds strong bones".[9] It is not pre-approved by FDA, but it needs substantiation and an FDA notification.[8]
Where can I find EU authorised health claims?
The European Commission keeps a public EU Register of Nutrition and Health Claims.[3] It lists authorised health claims with their conditions of use and restrictions, plus non-authorised claims and why they were rejected.[4] Always check both the wording and the conditions, such as minimum nutrient levels, before using a claim.
Can I reword an EU authorised health claim?
Be careful. Authorised claims can be used by all food business operators provided they comply with the claim's conditions of use.[2] In an EFSA opinion, the wording that reflects the evidence was "Vitamin C contributes to the normal function of the immune system."[7] Sticking to that wording is the safer route. This is general information, not legal advice.
What disclaimer do US supplement claims need?
Structure/function claims need this disclaimer in bold: "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."[10] You may not modify the wording, and the type size must be no smaller than 1/16 inch.[11]
Do I need FDA approval for a structure/function claim?
No. These claims are not pre-approved by FDA.[8] However, the manufacturer must have substantiation that the claim is truthful and not misleading, and must notify FDA with the claim text no later than 30 days after marketing the supplement with it.[8]
Sources
- [1] Regulation - 1924/2006 - EN - EUR-Lex — eur-lex.europa.eu
- [2] Health and Nutrition Claims on Food — fsai.ie
- [3] Nutrition and Health Claims - Food Safety - European Commission — food.ec.europa.eu
- [4] EU register of health claims - Food Safety - European Commission — food.ec.europa.eu
- [5] B COMMISSION REGULATION (EU) No 432/2012 of 16 May ... — eur-lex.europa.eu
- [6] REGULATION (EC) No 1924/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL — eur-lex.europa.eu
- [7] SCIENTIFIC OPINION ADOPTED: 28 October 2015 PUBLISHED: 13 November 2015 — iris.unimore.it
- [8] Structure/Function Claims — fda.gov
- [9] Label Claims for Conventional Foods and Dietary Supplements — fda.gov
- [10] Notifications for Structure/Function and Related Claims in Dietary Supplement Labeling — fda.gov
- [11] Dietary Supplement Labeling Guide: Chapter VI. Claims — fda.gov
- [12] Letter to the Dietary Supplement Industry on the DSHEA Disclaimer — fda.gov
Written by the Suplify Team with AI assistance, fact-checked against the sources listed above. General information only, not legal, tax or medical advice. Rules differ by country; check them for the markets you sell to.
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