Which food claims are allowed in the US and the EU?

In the United States, FDA allows nutrient content claims that use a term defined in 21 CFR Part 101, health claims that are authorised by regulation, notified under FDAMA (the Food and Drug Administration Modernization Act of 1997) on the basis of an authoritative statement, or covered by an FDA letter of enforcement discretion, and structure/function claims, which need no prior approval. In the European Union, Regulation (EC) No 1924/2006 allows only the nutrition claims listed in its Annex and the health claims on the Union lists, each with its conditions of use. The same words can be lawful in one market and prohibited in the other: "low sugars" is defined in the EU, while "low sugar" has no definition in the US.

Two systems built on different logic

The US defines claim categories and attaches conditions to each; structure/function claims need no authorisation. The EU uses a positive list: a claim is prohibited unless it is listed. A claim is judged by its meaning, not only by its words.

United States: three kinds of claim

Nutrient content claims. A claim that expressly or implicitly characterises the level of a nutrient may be made only as defined in Subpart D (21 CFR 101.54–101.69) or another applicable FDA rule (21 CFR 101.13(b)); some nutrient content claims are instead notified to FDA under FDAMA on the basis of an authoritative statement. "High" means 20% or more of the Daily Value (DV) per Reference Amount Customarily Consumed (RACC) (21 CFR 101.54(b)); "good source" means 10–19% (21 CFR 101.54(c)). Implied claims are covered too: "contains oat bran" claims that the food is a good source of dietary fiber (21 CFR 101.65(c)(3)). Above 13.0 g fat, 4.0 g saturated fat, 60 mg cholesterol or 480 mg sodium per RACC or per labelled serving (per 50 g if the RACC is 30 g or 2 tablespoons or less), the claim needs "See nutrition information for ___ content" (21 CFR 101.13(h)(1)); meal and main-dish products have higher thresholds.

Authorised and qualified health claims. A health claim links a substance to a disease or health-related condition, and can be implied by a heart symbol or a brand name containing "heart" (21 CFR 101.14(a)(1)). Authorised claims rest on "significant scientific agreement" (21 CFR 101.14(c)), are listed in 21 CFR 101.72–101.83, and are barred above the disqualifying nutrient levels (101.14(a)(4), (e)(3)). Except for supplements, the food must also supply 10% of the Daily Value of vitamin A, vitamin C, iron, calcium, protein or fiber before any nutrient addition (21 CFR 101.14(e)(6)). Both requirements apply unless a Subpart E regulation provides otherwise. FDAMA health claims based on authoritative statements (e.g. whole grains and heart disease) are notified to FDA rather than codified. Qualified health claims rest on less evidence: FDA issues a letter of enforcement discretion with set wording and qualifying language. It is not an approval, and the claims are not codified in Part 101.

Structure/function claims. On a dietary supplement, the claim needs the disclaimer in 21 CFR 101.93(c), placed as 101.93(d) requires, in bold type at least 1/16 inch high (101.93(e)). FDA must be notified within 30 days of first marketing (101.93(a)). The claim must not be a disease claim under 101.93(g)(2). On a conventional food, the effect must derive from nutritive value, and no disclaimer or notification is required. "Nutritive value" is defined in 21 CFR 101.14(a)(3), and the definition includes "providing energy". The point that a structure/function statement on a conventional food must derive from nutritive value is FDA's position in the preamble to its 2000 final rule on structure/function claims for dietary supplements (65 FR 1000, 6 January 2000).

European Union: a closed list, read for meaning

Nutrition claims. Only claims in the Annex to Regulation (EC) No 1924/2006 are permitted (Article 8(1)). Conditions are generally set per 100 g, per 100 ml or as a share of energy, not per serving (with few exceptions: table-top sweeteners, for example, are measured per portion, and "source" of a vitamin or mineral follows Annex XIII of Regulation (EU) No 1169/2011, under which a single-portion pack may be measured per portion). Examples:

• "Source of protein": at least 12% of energy from protein. "High protein": at least 20%.
• "Low fat": no more than 3 g/100 g for solids or 1.5 g/100 ml for liquids.
• "Low sugars": no more than 5 g/100 g or 2.5 g/100 ml. "Sugars-free": no more than 0.5 g/100 g or 100 ml.
• "Source of fibre": at least 3 g/100 g or 1.5 g/100 kcal.

Health claims. Health claims are prohibited unless authorised and listed (Article 10(1)). Article 13(1) function claims are listed in Regulation (EU) No 432/2012, applicable since 14 December 2012 and since amended. Each entry sets wording and conditions of use. For example, "Vitamin C contributes to the normal function of the immune system" requires the food to be at least a "source" of vitamin C. For vitamins and minerals, "source" under Annex XIII of Regulation (EU) No 1169/2011 means 15% of the nutrient reference value (NRV) per 100 g or 100 ml; for beverages it is 7.5% per 100 ml, and a single-portion pack may use 15% per portion. Article 14(1) covers reduction of disease risk claims and children's development claims, authorised individually; risk reduction claims must also state that the disease has multiple risk factors (Article 14(2)). A general wellbeing reference, such as "good for you", needs a specific authorised claim next to or following it (Article 10(3); Implementing Decision 2013/63/EU).

The four mandatory statements. Article 10(2) requires a label carrying a health claim to include:

1. a statement on the importance of a varied and balanced diet and a healthy lifestyle;
2. the quantity of the food and pattern of consumption needed for the claimed effect;
3. where appropriate, a statement addressed to people who should avoid the food;
4. an appropriate warning for products likely to present a health risk if consumed to excess.

On prepacked food the first two always apply, the last two where appropriate (Implementing Decision 2013/63/EU). None applies to nutrition claims.

Same meaning, not same words. Each Annex condition covers the listed claim "and any claim likely to have the same meaning for the consumer". Recital 9 of Regulation (EU) No 432/2012 applies the same principle to health claims. A faithful paraphrase is lawful if the conditions are met; wording that promises more than "normal function" is a different, unauthorised claim.

Ten common claims in both markets

Where the answer depends on the product, the table says on what.

Common mistakes

How RegaaS checks this

For US labels, RegaaS applies the 21 CFR Part 101 conditions for nutrient content claims, authorised and qualified health claims, "gluten-free" and structure/function claims. The redefined "healthy" claim is applied with the date it was checked. For supplements, it applies 21 CFR 101.36, and the structure/function disclaimer's placement, framing and type-size rules in 21 CFR 101.93(d)–(e).

For EU food labels, RegaaS applies Regulation (EC) No 1924/2006. It checks that only authorised claims appear, with conditions of use met and the mandatory statements present. Besides label artwork, RegaaS reviews packaging, marketing copy and web content, where many claims appear. It assesses meaning, not literal wording, so a lawful paraphrase is not reported as a violation. Each finding cites its provision, is marked on the label image and comes with suggested text.

Every rule applied gets one of four results: Compliant, Needs review, Potential risk or Not applicable. Where the information provided is not enough to decide, or the case is borderline, RegaaS marks the rule Needs review and refers it to regulatory staff instead of reaching a conclusion. Each Potential risk shows where the issue is on the label, the provision and the version in force, and a suggested revision. Whether a finding stands, and what to do about it, is decided by regulatory staff. When a provision is amended, RegaaS identifies the products already reviewed against it so they can be checked again.

What this guide does not cover

• FTC advertising substantiation, a regime separate from FDA labelling, which RegaaS reports as out of scope.
• EU food supplements. Their claims also fall under Regulation (EC) No 1924/2006, but RegaaS reports EU food supplement labels as out of scope.
• EU gluten statements (Implementing Regulation (EU) No 828/2014), lactose statements, fortification, additives and flavourings.
• Great Britain, which has its own claims regime (Northern Ireland applies EU rules), and Switzerland.
• Member State language rules and national enforcement, including treatment of on-hold botanical claims.
• US state requirements such as California Proposition 65.

Frequently asked questions

Is "high protein" defined the same way in the US and the EU? No. In the US it means 20% or more of the protein Daily Value per RACC (21 CFR 101.54(b)). In the EU it means at least 20% of energy comes from protein (Annex, Regulation (EC) No 1924/2006).

Can I use "low sugar" on a US label? No. FDA has not defined it. The defined sugar claims are "sugar free", "no added sugar", and the relative claims "reduced sugar", "less sugar" or "lower sugar" (at least 25% less than a reference food) (21 CFR 101.60(c)).

Do structure/function claims need approval? Not in the US, though supplements need the 21 CFR 101.93 disclaimer and FDA notification. In the EU, the equivalent claim must be listed in Regulation (EU) No 432/2012, or be an "on-hold" claim usable under Article 28(5)/(6) of Regulation (EC) No 1924/2006.

Must an EU health claim use the exact authorised wording? No. Wording with the same meaning is subject to the same conditions of use (recital 9, Regulation (EU) No 432/2012). Wording that changes the meaning is not authorised.

Can botanical claims "on hold" still be used in the EU? Some can, under Article 28(5) or (6) of Regulation (EC) No 1924/2006. Psychological or behavioural botanical claims need Article 28(6) (Case C‑386/23).

Primary sources

• 21 CFR 101.13 — Nutrient content claims
• 21 CFR Part 101, Subpart D
• 21 CFR 101.14 — Health claims
• 21 CFR Part 101, Subpart E
• 21 CFR 101.65 — Implied claims and "healthy"
• 21 CFR 101.91 — Gluten-free labeling
• 21 CFR 101.93 — Dietary supplement statements
• Final rule on "healthy", 89 FR 106064
• Delay of the "healthy" effective date
• FDA — Structure/Function Claims
• FDA — Qualified Health Claims
• FDA — Health claim notification for whole grain foods (FDAMA)
• FDA — Human Foods Program 2026 priority deliverables
• Final rule on dietary supplement structure/function statements, 65 FR 1000
• Regulation (EC) No 1924/2006 (consolidated)
• Regulation (EU) No 432/2012
• Implementing Decision 2013/63/EU
• Regulation (EU) No 1169/2011
• Implementing Regulation (EU) No 828/2014
• Case C‑386/23, judgment of 30 April 2025
• European Commission — Health claims

A RegaaS report is a documented review against the provisions above, not legal advice, and does not replace sign-off by a qualified regulatory professional.