Diagnostics as a Service and supplement health claims in Germany

Supplement brands usually buy Diagnostics as a Service around the time a lawyer reads the website and asks for part of the copy to be deleted. In the European Union a claim about a food has to be authorised, or it has to be one of the roughly 2,000 on-hold claims that may still be used at the operator's own responsibility¹². Everything below is a good-faith reading of the published rules rather than legal advice, so a lawyer has to approve your final claim set before it is published.

What may a supplement brand in Germany claim?

A supplement brand may use the nutrition and health claims that Regulation (EC) No 1924/2006 permits, in the wording the authorised entry allows, when the product meets the conditions of use attached to that entry¹.

A health claim about a food may be used only if it is authorised and listed in the Union Register, or if it is one of the roughly 2,000 on-hold claims, mostly botanicals². Member States submitted those on-hold claims by 31 January 2008 and their assessment is still suspended. On-hold claims may be used under Article 28(5) and 28(6) at the operator's own responsibility, subject to the Regulation's general requirements and to national rules. The Court of Justice addressed that division in case C-386/23 in April 2025, and the ruling is restrictive rather than permissive, because it treats Article 10(1) as a general prohibition and leaves botanicals usable only inside the transitional provisions⁷. Nothing outside those two routes may be used.

The Regulation covers commercial communication, which means the label, the packaging, the website, the advertising and the presentation of the product. A food supplement is a food in European law, so a supplement brand is inside these rules from the day it publishes a product page. The register is public, every entry names its conditions of use, and only a minority of the claims that companies submitted were authorised in the end².

Two whole categories are closed regardless of evidence. Food information may never attribute to a food the property of preventing, treating or curing a human disease³. The Regulation separately bans claims that suggest health could be affected by not consuming the food, claims about the rate or amount of weight loss, and claims referring to recommendations of individual health professionals¹.

What is the difference between a nutrition claim and a health claim?

A nutrition claim describes what is in the product, such as high in magnesium or a source of vitamin D. A health claim describes what that content does for the body, such as a nutrient contributing to the normal function of the immune system. The first is a statement about composition and the second is a statement about a relationship with health.

• A nutrition claim has to be one of the wordings in the Annex to the Regulation, with the amount conditions that go with it¹.
• A source claim generally requires a significant amount of the nutrient, which for a supplement means at least 15 percent of the nutrient reference value in the recommended daily portion³.
• A health claim has to be authorised and listed in the Union Register or used as an on-hold claim, with the mandatory accompanying information the Regulation names¹².
• That mandatory information includes a statement on the importance of a varied diet and the amount of the food needed for the claimed effect¹.
• Reduction of disease risk claims and claims about children's development are handled under a separate and stricter authorisation route¹.

The practical consequence for copy is that the composition sentence is usually easy and the effect sentence is usually the fight. Most founders write the effect sentence first, because it is the one that sells, so most claim reviews start by deleting it.

What does the Heilmittelwerbegesetz add for a supplement brand in Germany?

The Heilmittelwerbegesetz binds advertising for medicinal products, medical devices and other means, procedures and treatments where the advertising message refers to detecting, removing or relieving diseases or complaints in people⁴. A food supplement normally stays outside it, though the wording of an advertisement can pull the product inside.

That is the part founders get wrong. A supplement is regulated as a food while it is presented as a food, though a product presented as something that detects or relieves an illness can be treated as a medicinal product by presentation. A second body of law then applies to the same capsule. German advertising law also restricts what public advertising for such products may contain, including certain expert statements and material that creates fear⁴.

A blood testing offer has the same problem in a different place. Marketing a test as something that recognises disease is a message about detecting illness, so a wellness brand that describes its panel in medical language has moved itself into a regulated category it did not intend to enter.

Why do supplement founders take an Abmahnung seriously?

Because German competition law lets a competitor or a qualified association demand that you stop, and breaking a market conduct rule such as the claims Regulation is treated as an unfair commercial practice⁵. The letter usually asks you to sign an undertaking with a contractual penalty for any repeat, and to pay the sender's costs.

The cost of the first letter is rarely what damages a small brand. The undertaking is what does, because it binds you for the future and a second breach of the same wording triggers the agreed penalty without anybody going to court. Founders who have received one become careful in a way that reads as timid to their marketing team, and that caution is a reasonable response to how the system actually works.

• Your competitors have standing to act, so the complaint does not have to come from a customer or an authority.
• One product page can produce several objections at once, because each unauthorised sentence is its own breach.
• German food supervision authorities also review labels and websites, separately from any competitor.
• Removing the sentence later does not undo the breach that has already been published.

Does a measured value change what a supplement brand may say?

Yes for one named customer about their own result, and no for your advertising. Regulation 1924/2006 governs commercial communication about foods, so telling one customer that their measured ferritin is below the reference range is a statement about that person rather than a claim about a product¹.

This distinction is the centre of the whole subject, so it is worth being exact about both halves of it.

Here is what a measurement legitimately changes:

• You may report a person's own values, the reference range used and what the laboratory measured.
• You may explain why an authorised claim is or is not relevant to that individual customer.
• You may decline to recommend a product when the values give no reason for it.
• You may schedule a retest and describe what the second measurement showed for that person.

Here is what a measurement does not change:

• An unauthorised health claim stays unauthorised no matter whose blood was tested.
• Disease language stays banned for a food, because a low value is still not a diagnosis.
• General advertising still speaks to everybody, so it is judged as if no measurement existed.
• One person's result is never evidence for a population, which is a separate discipline of its own.

The honest summary is that measurement improves the truthfulness of a one-to-one conversation while leaving the advertising rules exactly where they were. That is still a large commercial gain, because the customer stops reading a generic promise and starts reading their own numbers.

There is one more line to respect. Interpreting an individual's results and telling that person what is wrong with them can be a medical activity in Germany, which is regulated separately⁶. A wellness brand therefore keeps the clinical layer with the provider allowed to hold it.

How can Diagnostics as a Service support a careful claim set?

Diagnostics as a Service gives a supplement brand the measurement and the report without giving it a second regulated business to run. The analysis, the collection, the software and the data agreement are covered by one contract, while your brand name, colours and domain are on the customer dashboard and the customer PDF.

• Panels are built with practising clinicians and researchers, and the protocols are reviewed by an advisory board.
• Results come with plain-language explanations per marker, so the report does not need claim wording to be understood.
• A trend view across repeated panels gives the customer their own comparison over time.
• GDPR terms with an AVV and Germany-hosted infrastructure are named in the contract.
• Aniva has 25+ partner draw locations across Germany, and the consumer membership is German while the partner offering is sold across Europe.
• Over 2,500 orderable parameters across eight modalities are available, so the panel matches the product range instead of the reverse.

What should a supplement brand do before publishing a claim set?

Write the claim set as a document before the website is built, because rewriting a product page after a warning letter costs more than writing it carefully once. Keep the register open beside the draft, mark every sentence with the authorised entry it relies on, and delete any sentence with no entry behind it.

• Separate the label copy, the advertising copy and the individual result explanation into three documents with three different rule sets.
• Record the conditions of use for each claim, since a claim used below its threshold is an unauthorised claim.
• Have a lawyer in food and competition law sign off the final set before publication, and repeat that review at every relaunch.
• Keep the sources for every factual statement where your team can find them again in a year.

Aniva sells optional supplement packs, so this problem is one we have to answer for ourselves as well as for partners. Book a 30-minute demo if you want the measurement layer under a claim set your lawyer has already approved.

Notes and sources

Last updated: 31 August 2026

1. Regulation (EC) No 1924/2006 on nutrition and health claims made on foods, EUR-Lex

2. EU Register of nutrition and health claims made on foods, European Commission

3. Regulation (EU) No 1169/2011 on the provision of food information to consumers, EUR-Lex

4. Heilmittelwerbegesetz, Gesetze im Internet

5. Gesetz gegen den unlauteren Wettbewerb, Gesetze im Internet

6. Heilpraktikergesetz, Gesetze im Internet

7. Court of Justice of the European Union, judgment in Case C-386/23, April 2025. curia.europa.eu