Common mistakes in health claims on supplements

The most common mistakes made in health claims on supplements are the use of medical claims, the inclusion of unauthorised claims and the incorrect wording of authorised claims. These are breaches of the European Claims Regulation (EC) No 1924/2006, which strictly defines what you are permitted to state on a supplement label. In this article, we answer the most frequently asked questions about health claims, so that you, as a brand, can avoid the most common pitfalls.

Which health claims are legally permitted on supplements?

Only health claims that have been approved by the European Food Safety Authority (EFSA) and are included in the European Register of Nutrition and Health Claims are permitted on food supplements. These claims must be scientifically substantiated and may only be used if the product meets the specified conditions, such as containing a minimum amount of the nutrient in question.

Under European legislation, there are two main categories of permitted claims:

• Nutritional claims: claims regarding the presence or quantity of a nutrient, such as “high in protein” or “source of vitamin C”.
• Health claims: statements about the link between a nutrient and health, such as “vitamin D contributes to normal bone structure”.

All these claims must correspond word for word to the approved wording in the EU register. Even a minor deviation in the wording, such as “strengthens your bones” instead of the approved wording, may constitute a breach.

What is the difference between a health claim and a medical claim?

A health claim refers to a positive effect on normal bodily functions, whilst a medical claim states that a product prevents, treats or cures a disease. Medical claims are completely prohibited on supplements. Only registered medicines may carry such claims, following approval by the competent authorities.

In practice, the distinction may sometimes seem subtle, but the line is clear. Here are a few examples:

• Permitted health claim: “Vitamin C helps the immune system to function normally.”
• Prohibited medical claim: “This product protects against colds and flu.”
• Permitted health claim: “Magnesium contributes to normal muscle function.”
• Prohibited medical claim: “Reduces muscle cramps in athletes with a deficiency.”

Brands regularly make mistakes in this regard by making claims that sound like health claims but actually suggest a therapeutic effect. Regulatory bodies such as the Netherlands Food and Consumer Product Safety Authority (NVWA) actively enforce this distinction.

What are the most common mistakes brands make when formulating claims?

The most common mistake is paraphrasing an approved claim rather than using the exact, registered wording. Other common mistakes include using claims on products that do not meet the required nutrient threshold, or making implied medical claims through images or slogans.

Below are the mistakes we come across most frequently in practice:

1. Free interpretation of approved claims: Amending or shortening the approved text, with the result that the claim no longer corresponds to the register.
2. Claims lacking sufficient active ingredient: Making a claim when the concentration of the substance in question is too low to meet the specified conditions.
3. Rejected claims: Using claims that have never been assessed by the EFSA or have been rejected by it.
4. Implicit medical claims: Suggesting a therapeutic effect through visual material, product names or slogans without stating this explicitly.
5. Incorrect target audience specification: Using claims relating to vulnerable groups such as children or pregnant women without the appropriate approval for that specific target group.

How do you check whether a claim has been approved by the EFSA?

You can check whether a health claim has been authorised by the EFSA via the official EU register of claims, which can be found on the European Commission’s website. This register contains all assessed claims, including the exact authorised wording, the relevant nutrient and the conditions under which the claim may be used.

The steps for verifying a claim are as follows:

1. Go to the EU Register of Nutrition and Health Claims on the European Commission’s website.
2. Search by the name of the nutrient or ingredient.
3. Check that the claim has the status “authorised”.
4. Please read the exact wording of the permitted terms and the associated conditions, such as minimum quantities.
5. Compare your own label text word for word with the approved wording.

Please note that rejected claims, also known as “on hold” claims, must not be used. Many brands mistakenly assume that a claim that was once used is still permitted. The register is updated periodically, so it is essential to check it regularly.

What are the consequences of an incorrect health claim on your product?

The consequences of an incorrect health claim can range from an official warning and a mandatory product modification to a fine or a compulsory product recall. In serious cases, a brand may also suffer reputational damage or be excluded from certain distribution channels such as supermarkets or online platforms.

The NVWA actively monitors the market for food supplements and may take the following measures in the event of a breach:

• A warning or instruction to amend the label.
• An administrative fine, depending on the seriousness of the offence.
• A ban on the placing on the market of the product.
• Publication of the breach, which may result in reputational damage.

For larger brands and retailers, compliance is not only a legal obligation but also a prerequisite for access to certain sales channels. Supermarkets and specialist retailers are increasingly requiring demonstrable compliance with product claims as part of their procurement policies.

How does a private label partner help to prevent claims errors?

An experienced private label partner helps to prevent claims-related errors by guiding the labelling process in line with current regulations, drawing up a food safety plan and checking that all claims comply with European standards before the product is launched on the market. This is particularly valuable for brands that do not have their own regulatory expertise.

A good manufacturing partner does not take over compliance responsibilities from the brand, but acts as a critical sounding board throughout the development process. This includes, amongst other things, assessing label concepts, advising on the correct wording of claims and tailoring the formulation to meet the required nutrient thresholds for specific claims.

How MixMasters helps ensure compliance with claims on your supplement label

We not only guide clients through the development and production of their supplements, but also actively assist them in drawing up an accurate and compliant label. For us, compliance is an integral part of the process, not an afterthought.

Specifically, here is what we offer in the field of food safety and labelling compliance:

• HACCP-based food safety plan: Together with consultants, we draw up a food safety plan that is specifically tailored to your product and production line.
• BRCGS certification: Our production complies with the BRCGS standard, an internationally recognised quality mark for food safety that assesses traceability, allergen management and regulatory compliance.
• Label support: Our team advises on packaging types, label design and the correct product specifications, including the information required by law.
• Accurate product information: Our quality team ensures that the product information on the label is accurate and complies with the recipe and the applicable regulations on product claims.

Whether you’re an established brand looking for a reliable alternative supplier, or an ambitious entrepreneur keen to launch a new range of supplements: we’ll ensure that your product is not only of the highest quality, but also compliant when it enters the market. Take a look at our services and options or Please contact us directly to discuss how we can support your brand.

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