Can a food supplement claim to prevent or treat a disease? What EU law allows
"Protects against colds", "treats joint pain", "heals the gut". Wording like this is common in supplement marketing, and in the EU it is not allowed for any food, food supplements included. This article explains where the ban comes from, what you may say instead, and how to reword typical sentences.
What the law says
Two rules apply side by side. For all foods, Article 7(3) of Regulation (EU) No 1169/2011 on food information to consumers says: "food information shall not attribute to any food the property of preventing, treating or curing a human disease, nor refer to such properties", subject only to derogations for natural mineral waters and foods for particular nutritional uses [1]. Article 7(4) extends the rule to advertising and to the presentation of foods, including their shape, packaging and the setting in which they are displayed [1].
For food supplements, Article 6(2) of Directive 2002/46/EC says the same thing again: "The labelling, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties" [2]. The ban therefore reaches product pages, ads and social media posts, not just the label.
Note the words "or refer to such properties": a sentence does not have to promise a result to break the rule. Hinting that the product helps people with a named disease can be enough.
What counts as a claim
Regulation (EC) No 1924/2006 on nutrition and health claims defines a claim as any non-mandatory message or representation, "including pictorial, graphic or symbolic representation, in any form", that states, suggests or implies that a food has particular characteristics [3]. It applies to labelling, presentation and advertising [3]. Pictures, icons and implied messages count as well as plain text.
What you may say instead: authorised health claims
A health claim is any claim that "states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health" [3]. Health claims are prohibited unless they are authorised and included in the EU lists of authorised claims [3]. The main list of general function claims is in the Annex to Regulation (EU) No 432/2012, which has applied since 14 December 2012 [4]. The European Commission keeps an EU Register of authorised and non-authorised claims, with their conditions of use [5].
Authorised function claims describe a normal body function, not a disease, and they come with conditions. For example, "Vitamin C contributes to the normal function of the immune system" may be used only for food which is at least a source of vitamin C as defined in the claims Regulation [4]. A health claim also requires extra information on the label, including a statement on the importance of a varied and balanced diet and a healthy lifestyle, and the quantity and pattern of consumption needed for the claimed effect [3].
Function claims for plant substances (botanicals) whose assessment has not been finalised do not appear in the EU Register [5]. Check their status with your national authority before using one.
The narrow exception: reduction of disease risk claims
The claims Regulation does allow one type of claim that mentions a disease: a "reduction of disease risk claim", which states that consuming a food "significantly reduces a risk factor in the development of a human disease" [3]. Such a claim may be made only after individual authorisation and inclusion in the EU list with its conditions, and the label must state that the disease has multiple risk factors and that altering one of them may or may not have a beneficial effect [3].
Other wording that is not allowed
- Claims suggesting that health could be affected by not consuming the food [3].
- Claims referring to the rate or amount of weight loss, such as "lose 5 kg in two weeks" [3].
- Claims referring to recommendations of individual doctors or health professionals, such as "recommended by doctors" [3].
- Any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general [2, 3].
- General, non-specific benefits such as "for overall wellbeing", unless accompanied by a specific authorised health claim [3].
A risk beyond food law
Under EU medicines law, a product "presented as having properties for treating or preventing disease in human beings" meets the definition of a medicinal product, and in cases of doubt the medicines rules apply [6]. Disease wording can therefore move a product out of the food category altogether.
Typical rewrites
- "Protects you from colds and flu" names diseases, so it has to go. If the product is at least a source of vitamin C, the authorised claim "Vitamin C contributes to the normal function of the immune system" may be used instead [4].
- "Treats joint pain" has no compliant version. If the product is at least a source of vitamin C, "Vitamin C contributes to normal collagen formation for the normal function of cartilage" may be used, as long as the surrounding copy no longer refers to pain [4].
- "Doctor recommended" and "modern diets can't give you enough magnesium" should be removed [2, 3].
A practical checklist
- Review every text the customer sees, including marketplace listings and influencer briefs, and remove disease names and symptom promises linked to the product.
- Match each health claim to an authorised claim in the EU Register without changing its meaning, and check the conditions of use against the actual formula.
- Add the statements that must accompany health claims.
- Check national rules and guidance with your competent authority.
When to talk to your doctor or pharmacist
For consumers: a food supplement is not meant to prevent or treat a disease, whatever an ad may suggest. Talk to your doctor or pharmacist before replacing a prescribed treatment, and tell them about every supplement you take.
This article is general information, not legal advice, and not medical advice, diagnosis or treatment. Always check the current legal text and your national requirements.
References
- Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, Article 7(3) and (4). EUR-Lex. https://eur-lex.europa.eu/eli/reg/2011/1169/oj/eng
- Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, Articles 6(2) and 7. EUR-Lex. https://eur-lex.europa.eu/eli/dir/2002/46/oj/eng
- Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (as amended), Articles 1(2)–(3), 2(2), 3, 10, 12 and 14. EUR-Lex. https://eur-lex.europa.eu/eli/reg/2006/1924/oj/eng
- Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health, Articles 1–2 and Annex. EUR-Lex. https://eur-lex.europa.eu/eli/reg/2012/432/oj/eng
- European Commission. EU Register of nutrition and health claims made on foods. https://food.ec.europa.eu/food-safety/labelling-and-nutrition/nutrition-and-health-claims/eu-register-health-claims_en
- Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, Article 1, points 1(b) and 2 (replacing Article 1(2) and Article 2 of Directive 2001/83/EC). EUR-Lex. https://eur-lex.europa.eu/eli/dir/2004/27/oj/eng