Lawyer helps with violations of the Health Claims Regulation

The case law regarding disease-related claims is relatively strict. For example, the Frankfurt am Main Higher Regional Court ruled on 12 September 2019 that dietary supplements may not be advertised as anti-hangover remedies, as a hangover would constitute an illness
(Ref.: 6 U 114/18).

Slimming-related claims such as slimming or weight-controlling properties of the food or claims that are about

• the reduction of the feeling of hunger or
• an increased feeling of satiety or
• reduced energy intake,

are permitted under Article 13(1)(c) of the HCVO if they are scientifically substantiated and do not mislead the consumer. However, claims such as "Lose four kilos in 14 days" or "Reduce your waist circumference by three centimetres in two weeks" are not permitted.

The Commission's list of permitted health claims is not exhaustive, but with over 200 examples of permitted claims, it provides a good basis for permitted advertising claims from which you can choose for your products. You can also find permitted nutrition claims directly in the Annex to the Health Claims Regulation. The formulation of your advertising claims is important. For example, formulations such as "to promote" or "to strengthen" are no longer equivalent to the permitted health claim "contributes to normal function/... contributes to normal function/...", as this permitted claim only refers to the maintenance of function and not to an improvement in function. The concept of health claims is to be interpreted broadly according to the case law of the Federal Court of Justice. If a connection between food and health is "suggested or even only indirectly expressed", this is sufficient for the existence of a health claim (BGH, judgment of 26.2.2014 - I ZR 178/1).

In addition to your direct competitors, the so-called "active legitimation" can also be held by associations with legal capacity or chambers of industry and commerce, for example. The IDO association, which has been issuing warnings since 2019 for breaches of the Health Claims Regulation and failure to provide mandatory information on food supplements, is often particularly aggressive in its approach. In recent years, the IDO has already been denied legitimacy several times. For example, the IDO was unable to demonstrate sufficient membership in the vitamins and food supplements sector before the Rostock Regional Court in 2019 (judgment of 25.04.2019, Ref. 5a HK O 112/18). A warning letter from an association without active legitimacy is inadmissible. You should therefore always have this checked on a case-by-case basis by a specialist lawyer before signing a cease-and-desist declaration for no reason.

Legal consequences of infringements of the HCVO

With the warning letter, the warning party primarily asserts claims for injunctive relief and demands the signing of a cease-and-desist declaration with penalty clause. In addition, warning costs are demanded and a contractual penalty is set, which is due in the event of a repeat infringement. In the case of warnings due to breaches of the HCVO, a competitor can also demand a recall campaign, for example, or force you to stop further sales until the breach has been rectified. Relabelling or even producing your goods again without the non-compliant claim can quickly become very expensive, so we recommend checking your advertising claims for legal compliance before you launch the products on the market.

Note that, unlike violations of the Product Safety Act, violations of the Health Claims Regulation are not the responsibility of the state authorities.

Do not simply sign the cease-and-desist declaration with penalty clause or pay the requested warning fees. Instead, contact a lawyer who specializes in taking action against warning letters under competition law. They will help you with:

• checking the legality of the warning letter
• negotiating transitional periods to limit economic damage
• negotiating down the contractual penalty
• adjusting the cease-and-desist declaration
• removing the infringement of competition law

Document your infringement before you remove it. Although the claimant must prove the infringement, even if an out-of-court settlement is reached, the warning letter may later claim that you have repeated the infringement or not completely remedied it and then demand the contractual penalty. Precise documentation of the original infringement and the remedial measures will help here.

Act quickly!

If you do not respond within the deadline set for submitting a cease-and-desist declaration, the warning party will apply to the court for an injunction, which will inevitably prolong the case and make it more expensive. If the court then has to decide in further proceedings whether there has been an infringement or not, the injunction proceedings may have to be conducted over three instances up to the Federal Supreme Court (BGH). We want to avoid this! Therefore, immediately after receiving the warning letter, contact a lawyer who specializes in taking action against warnings under competition law and who will take care of the matter in a timely manner. Our out-of-court settlement rate is around 90%.