Health claims for botanicals – What the new ECJ judgement means for advertising!

Health claims for botanicals - What the new European Court of Justice  (ECJ) ruling means for advertising! Plants have been used for centuries as a source of healing power, well-being and life balance. They are therefore a popular central motif in modern product communication - especially in the area of food supplements. With claims such as “melon juice reduces stress” or “saffron promotes emotional balance”, manufacturers are trying to hit a nerve: the need for natural support in times of stress. But what can legally be said about such herbal substances? And where does the deception begin? In the following sections, you will find out what the legal framework for health claims about herbal substances looks like, why the new ruling by the  ECJ on April 30, 2025 represents a turning point, what consequences this has for manufacturers and what regulatory adjustments may now be necessary.

Saffron, melon, ginseng or ashwagandha - many plant-based substances, known as botanicals, enjoy a reputation steeped in tradition. Used for centuries, they are now more than ever the target of scientifically based research. Using these approaches, they find their way into modern formulations, from herbal medicines and dietary supplements in particular to foods in general. Corresponding product texts often use phrases such as “supports relaxation” or “promotes well-being”.

However, the boundary between permissible information and health claims is narrow. According to Regulation (EC) No. 1924/2006, health claims may only be used if they have been scientifically tested and included in the relevant lists in accordance with Article 13 or 14 of this Regulation. Numerous herbal substances are still awaiting final evaluation by the European Food Safety Authority (EFSA) and authorization by the European Commission. This evaluation gap has been used as a leeway in the past - with growing legal uncertainty. The more widespread this practice became, the more frequently legal disputes arose.

Between hope and legal uncertainty: the practice before the ruling!

During the transition period, many manufacturers referred to traditional applications or individual studies. Advertising messages remained deliberately vague so as not to overstep regulatory boundaries, although health benefits were suggested through clever wording. Statements such as “contributes to inner balance” were common - without any legal basis.

This practice has increasingly become the focus of competition associations and supervisory authorities, but the legal grey area is still often used to exploit effective advertising niches. Lawsuits, warnings and proceedings have accumulated in the past, until one such case finally ended up before the European Court of Justice.

ECJ ruling of April 30, 2025: legal clarity with consequences!

The Novel Nutriology GmbH ./. Verband Sozialer Wettbewerb e. V. case was more than an industry-specific individual case - it became a litmus test for the previously tolerated practice of advertising claims on herbal substances. The ECJ took the opportunity to clarify key questions of principle and send a clear signal in the direction of harmonized consumer protection standards. In future, health claims on herbal substances will only be permitted if they have been scientifically substantiated and approved by the European Commission.

A prohibition with reservation of permission therefore follows:

Regulation No. 1924/2006 stipulates that health claims for foods and food supplements are generally prohibited unless they are included in the positive list in accordance with Art. 13 or 14 of the Regulation. General formulations such as “has a mood-enhancing effect” or “supports well-being” also fall under the ban unless they are combined with a verifiably approved health claim.

The fact that the evaluation of health claims on herbal substances has been suspended by the European Commission does not create a temporary gap in protection - the ban also applies here.

However, exceptions are possible: health claims that fall under the transitional provision of Art. 28 para. 6 of Regulation No. 1924/2006 may be used - provided that the requirements set out in this provision are met.

With this decision, the ECJ is sending a clear message for the future direction of travel. The lingering in the grey area is now gradually coming to an end: instead of grey, red will apply in the future. Only what has been scientifically proven and confirmed may be used in advertising with health claims. This should mean a sigh of relief for the pharmaceutical industry in particular, as the ruling also more clearly outlines the distinction from herbal medicinal products and better protects their status from false claims by the food industry.

Anyone who makes health claims about the effects of herbal substances bears full regulatory responsibility - even if the evaluation process at EU level is stagnating. For the industry, the ruling means that previous strategies must now be put to the test

Regulatory homework: What is needed now!

In light of this ruling, food business operators and, in particular, providers of food supplements that advertise health claims relating to herbal substances are required to comprehensively review their external presentation.

• Health claims on labels, in online stores or in printed materials must be fully recorded and evaluated.
• A comparison with the current EU positive list is mandatory. It must be checked whether statements fall under the transitional provisions of Art. 28 para. 6.
• Non-compliant statements must be deleted or replaced by legally validated formulations.
• The underlying scientific evidence must be documented in a comprehensible manner.

Conclusion: Legal certainty requires foresight - and professional support!

The ECJ ruling of April 30, 2025 provides clarity - but also increases the pressure to act. Anyone wishing to continue advertising herbal substances must now do so with scientific backing and a clear legal basis. The much-used transitional phase of uncertainty and grey areas is over.

The experts at TentaConsult Pharma & Med GmbH have been supporting companies in complying with regulatory requirements for many years. They provide support with

• the inventory and legal review of existing claims,
• the formulation of permissible statements in accordance with EU requirements,
• coordination and communication with authorities
• and strategic communication around plant-based products.

Legally compliant communication not only protects against sanctions - it also strengthens consumer confidence.