The judgement of the Higher Regional Court of Koblenz provides a well-structured summary of the excessive criteria established by German supreme court case law for advertising with health claims using the example of a dietary supplement with regard to a sleep-promoting effect of herbal ingredients for which on-hold claims are pending. With extensive reference to current supreme court case law, the judgement takes the reader point by point through the sequence of checks to be observed, at the end of which there is hardly any room for information apart other than mandatory information. The decision thus joins the ranks of overly strict national case law, which does not exist in this form in any other member state of the European Union, so that the question arises as to whether the discussion of the conformity of Section 3a UWG (Section 11 No. 4 UWG old version) with European law could be reignited here.
The judgement is in line with the strict case law of the highest courts in recent years as to why the scope of the Health Claims Regulation applies to all statements in the product presentation at issue and why, despite the use of approved claims for a sleep-promoting effect for melatonin and four other herbal ingredients of the product – passionflower, California poppy, lemon balm and valerian – for which claims on hold are made in relation to sleep promotion, the statements at issue in the specific product presentation are inadmissible. For the use of botanical claims, despite the recognised flexibility of wording, the court of first instance strictly denied any consistency in terms of content and, despite the submission of 31 scientific publications and an observational study with the product as well as a study with a comparable product from another Member State of the European Union, ruled that there was insufficient scientific evidence for the statements made, although there is knowledge on the sleep-promoting effects of all ingredients.
The case law to date is now crowned by the question referred to the ECJ by the Federal Court of Justice, decision of 1 June 2023, case no. ZR 109/22, as to whether claims for botanicals that fall within the scope of the HCVO may be advertised at all as long as the EFSA’s assessment and the Commission’s examination of inclusion in the Community lists pursuant to Articles 13 and 14 HCVO have not been completed.
The current German supreme court case law, with which the judgement of the Koblenz Higher Regional Court is in line, ultimately amounts to precisely that.
At issue before the Koblenz Higher Regional Court was a food supplement that is marketed in tablet form and contains the ingredients melatonin 1 mg and various plant extracts, including passionflower, California poppy, lemon balm and valerian, in three different layers.
The European Food Safety Authority (EFSA) has authorised the claim “Melatonin contributes to shortening the time it takes to fall asleep” for melatonin with a quantity of 1 mg per stated daily portion. This is therefore a health claim authorised under Article 10(1) of the HCVO, the conditions of which are met in accordance with Regulation (EU) 432/2012 establishing a list of permitted health claims for use in the food supplement in question.
The front of the packaging showed the tablet, which had the special technical feature of three-layer technology, which was also advertised. The three layers were then shown both as a photo and highlighted in colour in the form of a graphic tablet, whereby the layers were numbered 1, 2 and 3 and headed with the statements ” reduction of time taken to fall asleep”, “Promotes sleeping through the night” and “Promotes relaxation”. The ingredients contained in each layer were then listed underneath, with a superscript number assigned to each of the statements ” reduction of time taken to fall asleep, promotes sleeping through the night and promotes relaxation” – ¹ in tablet layer one, ² in tablet layer two and ³ in tablet layer three, which was then only found on the ingredients listed immediately below in the respective layer to which the heading referred: with regard to “promotes s falling asleep” the ingredient melatonin with regard to “promotes sleeping through the night” the ingredients passionflower and Californian poppy, for which there are claims on hold, and for “promotes relaxation” the ingredients lemon balm and valerian, also botanicals with claims on-hold for a sleep-promoting effect.
On the back of the packaging was the resolution of the meaning of the superscript numbers and again a description of the three layers with further explanations.
First of all, the Higher Regional Court of Koblenz found that the design of the packaging of the product at issue constituted a commercial act within the meaning of the UWG because it qualified as advertising and therefore fell within the scope of application of Sections 8 (1) and 3 (1) UWG.
This commercial act was unfair pursuant to Section 3a UWG in conjunction with Art. 10 (1) HCVO.
The scope of application of the HCVO was opened. Food supplements are foodstuffs pursuant to Art. 2 para. 1 a HCVO in conjunction with Art. 2 a of Directive 2002/46/EC and the claims at issue are made to promote the sale of goods – Art. 1 para. 2 HCVO stipulates that the HCVO only applies to nutrition and health claims made in commercial communications in the labelling, presentation or advertising of foodstuffs intended to be supplied to the final consumer.
It is then established that the provisions of the HCVO constitute market behaviour regulations within the meaning of Section 3a UWG.
Subsequently, with regard to Art. 10 para. 1 and Art. 2 para. 2No. 5 as well as Art. 10 para. 3 HCVO, it is subsumed what specific and general health claims are.
In summary, the Higher Regional Court of Koblenz found with regard to the disputed product and the disputed statements that, overall, the statements were specific health claims within the meaning of Art. 10 (1) of the HCVO because, according to the understanding of the average consumer who is reasonably well-informed and reasonably observant and circumspect, they all relate, at least in context, to symptoms of a pathological condition in the form of sleep disorders. The average consumer would understand them in the specific context to mean that the advertised product, when taken, would at least help to improve or even completely eliminate the corresponding symptoms and thus a pathological condition in the form of sleep disorders.
The information contained in the advertising on the time of consumption, the addressee of a special target group and purely technical descriptions, which are not health-related in principle and therefore not covered by the scope of the HCVO, are not present in the specific advertising because the targeted consumer would not understand them as technical descriptions with regard to the claim “sleep aid and to promote restful sleep through the night” and an advertised “synergistic effect” of some ingredients. The targeted consumer would understand the technically described structure of the tablet with three layers in the sense of an overall special health-promoting effect.
In the specific advertising, the words “additional” and “synergistic effect” would give the consumer the impression that all ingredients work together with melatonin, for which an authorised claim exists, and have an even better sleep-inducing effect.
This impression would also not be corrected by the superscript numbers assigned to the individual ingredients, particularly in view of the fact that the three phases in the tablet shown have a uniform colour background.
It is precisely here that the reasoning of the Koblenz Higher Regional Court shows what has always been established case law in the area of injunctions under competition law – it always depends on the specific advertising and design in the individual case in the overall context. In the present case, the Koblenz Higher Regional Court did not consider the classification with superscript footnotes to be clear enough against the background of a uniform colour design of the tablet layers – conversely, a design with different colour highlighting and superscript footnotes could still result in a different assessment depending on the circumstances. There is not much room for manoeuvre in the design of advertising within the framework of the Health Claims Regulation, but a certain amount of creativity can be used in individual cases. The decisive factor in this respect is how the individual statements relate to each other and how footnotes and colours are used in the overall impression.
Based on the strict standard to be applied, the Koblenz Higher Regional Court found that the claim for the first layer under the heading “reduction of time taken to fall asleep” for the existing ingredient melatonin was permissible, while the listing of the other ingredients and the resolution on the reverse side “additionally contains … for a synergistic effect” was inadmissible.
With the same assessment, the court considered the claim “promotes sleeping through the night” in relation to passionflower and Californian poppy to be inadmissible.
The content of the pending claims would allegedly not support the statement – pending are “Helps to induce calm rest and sleep”, “Contributes to optimal relaxation/contributes to a normal sleep/helps to maintain a healthy sleep” and “Contributes to optimal relaxation/helps to support the relaxation/improves the quality of natural sleep” and, moreover, the claims were also not sufficiently scientifically substantiated.
With regard to the criteria for sufficient scientific substantiation, current case law is cited and it is summarised that it must be proven that the substance in question actually has the claimed effect (Art. 5 para. 1 a) HCVO), that the substance is present in the user’s products in a relevant quantity (Art. 5 para. 1 b) HCVO), that it is present in a bioavailable form (Art. 5 para. 1 c) HCVO) and that it is capable of producing the effect claimed by the user when reasonably consumed (Art. 5 para. 1 d) HCVO).
The burden of presentation and proof for this lies with the person using the claim in accordance with Article 6(2) of the HCVO and with reference to ECJ and national supreme court case law.
With regard to the criteria for sufficient scientific substantiation in relation to these four points, the Koblenz Higher Regional Court subsumed that sufficient scientific substantiation had not been credibly demonstrated.
With regard to the own study with the comparable product from another Member State, this preparation did not correspond in its combination of active ingredients to the product in dispute here – in fact, exactly the same ingredients were contained in the identical quantity, only twice the quantity was contained for the approved ingredient melatonin. However, further scientific evidence was also submitted for the individual ingredients contained in the combination of active ingredients in this quantity, whereby it should be noted that a calming, sleep-promoting effect is well known for lemon balm and valerian, in particular. In this regard, the Higher Regional Court of Koblenz stated that if individual substances in the combination already have a scientifically proven effect on their own, the extent to which this effect continues to exist in combination with the other components or is strengthened, weakened or otherwise modified under certain circumstances must also be examined. In addition, the scientific evidence must also relate to the same proportions of the substance or foodstuff. In this respect, in the case of a combination of different substances, the proof of efficacy must be provided for the specific combination of substances.
The observational study submitted for this product in exactly the specific combination of substances is not sufficient because it is not recognisable that the group of participants was selected to be sufficiently representative. In addition, observational studies are not sufficiently meaningful because they are only based on the self-assessments of the test subjects and placebo effects are not recorded because no placebo control took place.
Scientific publications that contain observations in animals or other combinations of substances or other dosages of the relevant substances than in the product at issue should not be taken into account for this reason alone and are not sufficient as scientific evidence. It is not sufficiently clear from them to what extent the positive effect described by them is given in combination with the other components of the product at issue or, under certain circumstances, is strengthened, weakened or otherwise modified. Insofar as positive evidence on the total duration of sleep could be inferred from the documents, this would not be evidence of positive effects on sleeping through the night.
Against the background of the current strict national case law, food supplements can currently only be advertised within the framework of the general rules of competition law. Accordingly, the relevant statement in the overall context of the advertising is always decisive, whereby the specific design is decisive for the overall context and the assessment of how the targeted consumer understands the individual specific claims in dispute. According to this case law, even claims that would not in principle fall within the scope of the Health Claims Regulation, such as technical descriptions and instructions for use, can become health claims in the overall context if they are not clearly differentiated from other claims. It is therefore important that there is a specific reference to the substance, a clear visual classification and, in the case of botanicals, a scientific substantiation that provides concrete evidence of the ingredients referred to in the specific quantity or in their overall combination in the case of several ingredients. Furthermore, advertising can only be made with statements that are such general advertising phrases that – in the overall context of the advertising – they do not open up the scope of application of the Health Claims Regulation (e.g. the meaningless advertising slogan “fountain of youth” for a pomegranate juice – LG Munich I, judgement of 25 October 2012, Ref. 17 HK O 18708/12).
Ultimately, it can only be hoped that the ECJ will consider advertising for botanicals to be permissible in principle with regard to the free movement of goods and the protection of the freedom to choose an occupation enshrined in Article 12(1) of the German Constitution, which is also protected under European law, and that it will set requirements that could possibly impose limits on strict national jurisdiction with regard to the free movement of goods and harmonisation of the European single market. A comprehensive ban on advertising could affect the rules for the professional image of food supplement manufacturers and thus be directly related to their occupation. Whether this would actually be constitutionally justified on health grounds is doubtful, particularly in light of the current European consumer model of the normally informed, attentive and reasonable consumer.
However, it is not to be expected that the ECJ will position itself so clearly that even if the advertising of botanicals continues to be permitted at European level, this will bring about a change in the strict national case law.
But, as we all know, hope dies last.
