The Federal Court of Justice (BGH) decides on health-related advertising for botanicals and prohibits the use of health claims without EU approval – Judgment of 5 June 2025 (I ZR 109/22, "Botanicals II")

Further decision on botanicals – health claims remain a legal pitfall in the food and dietary supplement market

Health-related claims ("health claims") are a central marketing tool for food and dietary supplement manufacturers. Statements such as"supports heart health"or"promotes memory performance"are intended to convince consumers to purchase a product. However, this advertising is strictly regulated: theHealth Claims Regulation (HCVO, Regulation (EC) No. 1924/2006)provides that such claims must be scientifically substantiated, approved by the EU Commission and published in a community list.

For years, however, there has been aregulatory gap for botanicals, i.e. herbal ingredients such as saffron, lemon balm or ginseng. Many manufacturers exploit this grey area to advertise products with promises such as "strengthens immune defences" or "reduces stress symptoms" – even though the European Commission has not yet made a final decision on these claims.

With its new judgment"Botanicals II"(I ZR 109/22)of 5 June 2025 – published on 30 July 2025 – the Federal Court of Justice (BGH) has adopted the preliminary ruling of the Court of Justice of the European Union (EuGH) and has now provided clarity:Advertising with unapproved health-related claims for botanicals remains prohibited – even during the ongoing EU review.

On the preliminary ruling of the Court of Justice of the European Union (EuGH) of 30 April 2025 (C-386/23 "Novel Nutriology") on the advertising of botanicals, we have already reported (seeNews from the Court of Justice of the European Union (EuGH) on botanicals and their advertising).

Facts: Saffron and melon juice extracts with anti-stress promises

In the underlying case, the defendant distributed adietary supplementnamed "Adapto-Genie ANTI-STRESS-COMPLEX". On its website, it advertised the product with statements such as:

• "mood-enhancing saffron extract"
• "77% of users experienced an improvement in emotional balance after two weeks"
• "Melon juice extract demonstrably reduces stress feelings and exhaustion"

TheVerband Sozialer Wettbewerb e.V.considered these statements to be impermissible health claims and sued for cessation.

• Regional Court (LG) Hamburg(judgment of 29 June 2021) and
• Higher Regional Court (OLG) Hamburg(judgment of 2 June 2022)

upheld the association and prohibited the defendant from advertising. The defendant appealed and argued that due to the lack of an EU approval list for botanicals, a"transitional phase"applied, which would permit such claims.

Legal reasoning of the BGH: Clear rejection of advertising without approval

The Federal Court of Justice (BGH) confirmed the judgments of the lower courts and established in its judgment of 5 June 2025 (I ZR 109/22 "Botanicals II") – with reference to this preliminary ruling – the following key statements:

1. Applicability of the HCVO to botanicals

• The Health Claims Regulation applieswithout restrictionalso to herbal ingredients ("botanicals").
• The fact that the EU Commission has not yet completed the assessment of the claims does not exempt companies from the obligation to use only approved claims.

2. No advertising exemptions during the "on-hold" phase

• For health-related claims concerning mental functions (for example stress reduction, emotional balance), strict transitional rules apply (Art. 28 HCVO).
• These permit continued use only ifbefore 19 January 2008an application for approval was filed.
• In the present case, there was no timely filed application – therefore no protection under the transitional provision.

3. Prohibition of specific and non-specific claims

• Specific claims(Art. 10 para. 1 HCVO) such as "reduces exhaustion" are prohibited without approval.
• General, non-specific claims(Art. 10 para. 3 HCVO) such as "promotes well-being" are only permissible if they are combined with anapproved specific claim– which was not the case here.

4. Right to cessation under competition law

• Violations of Art. 10 HCVO constitute a violation of market conduct rules (§§ 3, 3a UWG).
• Competitive associations such as the claimant can therefore successfully demand injunctions and reimbursement of warning letter costs.

Practical consequences of Botanicals II and action recommendations for enterprises

This ruling has significant implications for all manufacturers and dealers of dietary supplements containing herbal ingredients:

• Clear advertising restriction: Health claims relating to botanicals are prohibited even during the open EU review if they have not been approved.
• High risk of warning letters: Competitive associations and competitors can issue warnings for such violations at cost and obtain judicial injunctions.
• Avoidance of fines and reputational damage: In addition to judicial prohibitions, substantial administrative fines and considerable reputational loss threaten.

Recommendation:

Enterprises should review their product advertising and online content immediately. Unapproved health claims for botanicals must be removed or amended. A preliminary legal review by AVANTCORE Rechtsanwälte in Stuttgart as specialised law firm in Wettbewerbsrecht is urgently recommended in order to avoid costly Abmahnungen and legal proceedings.