Probiotic health claims remain tricky

“Supports your intestinal flora” sounds harmless. Yet that promise cannot simply be used in advertising. This becomes extra clear in a recent ruling by the Dutch Advertising Code Committee (ACC). In this blog, I will analyse how the ACC reaches its decision, and what it reveals about the scope, or rather the limitations, for such and similar health claims.

The case
The label of the product Beautiful Immunity Kefir Mild contains, among others, the statements that kefir supports the intestinal flora (in Dutch: kefir ondersteunt de darmflora) and that their kefir drinks are high in protein, low in fat and a source of calcium and vitamin B12 (In Dutch: onze Kefir-drankjes bevatten veel eiwitten, weinig vet en zijn een bron van calcium en vitamine B12). Furthermore, two claims are made:  calcium and vitamin B12 for your gut health* and support of your immune system** (In Dutch: calcium en vitamine B12 voor uw darmgezondheid* en ondersteuning van uw immuunsysteem**). The label also contains claims about *calcium supporting the normal function of digestive enzymes (in Dutch: *Calcium draagt bij tot de normale werking van spijsverteringsenzymen) and **vitamin B12 supporting the normal function of the immune system (in Dutch: **Vitamine B12 draagt bij tot de normale werking van het immuunsysteem).

Designation kefir mild
According to the complainant, the naming of the product “kefir mild” is confusing consumers. They would think this variant of kefir contains yeasts and alcohol, like the traditional kefir does, but in reality, it doesn’t. The ACC mentions that the advertiser must use a customary or descriptive name for the product. Kefir is designated as a milk product. In the Netherlands, kefir is not a protected product name or a legally established designation, like other dairy products as milk or cheese. According to Beautiful Immunity, a distinction must be made between commercial and traditional kefir. Since shops will mainly sell the commercial variety, which, like “mild kefir”, does not contain yeasts, the ACC does not consider this designation for “mild kefir” to be incorrect or insufficiently specific. The average consumer will think that it is kefir with a mild taste and not traditional kefir with yeasts. Therefore, the naming of the product “kefir mild” isn’t confusing for consumers. The ACC rejects this complaint. Nevertheless, Beautiful Immunity currently designates its product just as “kefir”.

Health claim
Secondly, the complaint states the text displayed on the label contains a misleading health claim. This concerns the claim that the kefir product supports the intestinal flora and contains billions of live cultures. According to the complainant, this suggests a broader effect than the product actually offers, especially since the product does not contain yeasts and does not undergo a traditional fermentation process. The ACC rules that the claim “supports the intestinal flora” qualifies as a health claim. According to article 10 of the Claims Regulation, only authorised health claims can be used. A quick research in the EU Health Claims Register reveals there is no authorised health claim linked to kefir.

Furthermore, article 5(1)(b) of the Claims Regulation requires a health claim to be specifically linked to ingredients or substances. In this case, the advertiser attributes the claimed effect to kefir and not to the ingredients calcium or vitamin B12. More specifically, Beautiful Immunity indicates that the health claim about kefir supporting the intestinal flora is a generic health claim that is accompanied by to the authorised claim for calcium stated on the back of the packaging (article 10(3) of the Claims Regulation).

The ACC does not agree. According to the ACC, the health claim “supports the intestinal flora” is located under the word “kefir” on the front of the packaging. Consumers will read that Beautiful Immunity claims that kefir supports intestinal flora. The name of the product and the health claim follow each other directly and appear to be related. This claim cannot be linked to the claim “Calcium contributes to the normal function of digestive enzymes”. The reason is that the claim is located on the back of the packaging and an asterisk that can clarify the link between the claims is missing. It is therefore an independent health claim, see the ruling of the Court of Justice of 30 January 2020, case C-524/18.

Because there is no authorised health claim for kefir, the health claim that kefir supports the intestinal flora is contrary to article 10(1) of the Claims Regulation. This results in the ACC concluding that this claim is not in accordance with the law as referred to in article 2 of the Dutch Advertising Code, so the ACC upholds the complaint.

For gut health
Beautiful Immunity states that it regularly updates its labelling and that the claim “supports intestinal flora” no longer appears on the new label. Instead, the text “For gut health” is used. This claim is more generic, but if it substitutes the text “supports the intestinal flora”, it is still displayed under the word “kefir”. So, it remains an independent claim about kefir, that is unauthorised. This shows claims about gut health, intestinal flora and probiotics remain tricky.

Intestinal flora and probiotic claims
In this procedure the ACC rules that the health claim that kefir supports the intestinal flora is not permitted and therefore contrary to article 2 of the Dutch Advertising Code. The health claim was actually intended for calcium. What is striking is that the ACC attributes the unauthorised nature of the health claim to the fact that it refers to kefir rather than calcium. The ACC does not assess the admissibility of claims about intestinal flora in general here. Would the health claim “supports the intestinal flora” be permitted if it referred to calcium rather than kefir?

One could argue that in this case article 10(3) of the Claims Regulation is complied with, assuming that the claim is accompanied by the authorised calcium health claim, but caution should still be exercised with health claims about intestinal flora. In the Netherlands, the list of the on hold claims, drawn up by the Dutch Health Advertising Knowledge and Advice Council (in Dutch: Keuringsraad), distinguishes between the categories of digestion and intestinal flora. This suggests that the claim about intestinal flora cannot be accompanied by the authorised claim that calcium contributes to the normal function of digestive enzymes. In fact, there still aren’t any authorised health claims on intestinal flora or probiotics, see our previous blog about probiotic claims.

In the meantime, the European Ombudsman closed a case about probiotic health claims. This case was about the interpretation of the term probiotics by the European Commission. According to the European Commission, the word probiotics suggests a health claim, while the complainant, an association of producers of probiotics, argued that this word rather suggests a nutrition claim. The European Commission intends to protect consumers from potentially misleading information about food. As such, it is not surprising for the Commission to interpret claims about probiotics as health claims. The European Ombudsman accepts the explanation of the European Commission that it does not rule out submitting new applications to authorise probiotic health claims in the future, if the health benefits are scientifically proven.

Conclusion
The ACC rejects the complaint about the name “kefir mild”, as it is accurate and sufficiently specific. The average consumer will think that the term “kefir mild” refers to kefir with a mild taste, and not to traditional kefir containing yeast (including alcohol). The ACC however upholds the complaint regarding the health claim “supports the intestinal flora”. In essence, the ACC rules that consumers would think that the claim is about kefir. And the claim that kefir supports the intestinal flora is an unauthorised health claim. In fact, all health claims about intestinal flora are unauthorised. The same applies to health claims about probiotics. This may change in future, if and when these types of claims are substantiated by scientific evidence regarding the health benefits offered. So, think twice, when selling the health benefits of your gut health product. And of course, I would be happy to help out in case of doubt.

The full case can be read here (in Dutch).

Image: https://nl.beautifulimmunity.eu/


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