What can you claim? The playing field per product category

What you're allowed to communicate about a health product is determined by that product's legal category. Food supplements, medical nutrition, medical devices, and medicines each fall under their own framework, with their own oversight. An overview, and how to work with it strategically.

The question of what you're allowed to claim is rarely simple in this sector. Every product type has its own regulations, regulator, and room to maneuver, and those differences are substantial. A product's classification follows from its nature, composition, and presentation, and subsequently determines the entire communication framework. Whoever doesn't have that framework clearly in view runs into rejections or enforcement. Whoever does master it finds surprisingly much room within the boundaries.

Oversight: self-regulation and statutory enforcement

In the Netherlands, much runs through self-regulation. The Keuringsraad (Advertising Code Authority for health products) pre-vets public-facing claims via KOAG (medicines) and KAG (health products and medical self-care devices), based on the Leidraad (Guideline). An approved claim receives an authorization number, which media and retail treat as a condition for placement. Communication toward professionals falls outside this public framework and under the CGR, the Code of Conduct for Pharmaceutical Advertising. Above that sits statutory enforcement: the NVWA for food products and the IGJ for medicines and devices, with the authority to issue fines and enforcement measures. Self-regulation and legislation work here in layers on top of each other.

Food supplements: the Claims Regulation as a binding register

Supplements fall under food law and therefore under Regulation 1924/2006. The starting point is restrictive: only health claims approved in the EU register are permitted, and solely for the substance and application for which they're authorized. The exact wording isn't set in stone. Wording with the same meaning for the average consumer is permitted, which leaves room for brand language. The boundary lies at the medical claim: any reference to preventing, treating, or curing disease is prohibited. An important detail that's often underestimated: the presentation criterion from the Medicines Act means a product presented as combating disease can be classified as a medicine, regardless of its composition. It's not the claim that changes the category, but the presentation that determines which regime you fall under.

Botanicals: the on-hold status as a gray area

Botanicals are subject to an exception. The EFSA assessment of many herbal claims was suspended years ago, leaving these claims with an on-hold status. They're not approved, but not prohibited either, and may be used under conditions as long as they're not misleading and align with the indicative list. That requires its own risk assessment: the status can change once the Commission resumes the assessment. For brands with botanical ingredients, this is strategically relevant, because part of the communication foundation is legally uncertain.

Medical nutrition: the condition as the core

Food for medical use is a standalone category under its own European regulation. Where the supplement has to avoid the disease, here the condition is central: the product is intended for the dietary management of a specific disease, under medical supervision. The condition may and must be named. That comes with a heavier burden of proof, with requirements around scientific substantiation, composition, and labeling. It's a category often confused with supplements, while the communication framework is nearly its mirror image.

Medical devices: the CE mark determines the scope

A medical device derives its function from a physical, non-pharmacological route and falls under the MDR. The CE mark is the proof of conformity and links the product to a defined intended purpose. That intended purpose sets the boundary of your claims: you may communicate what the certification covers, substantiated by the technical and clinical documentation, and not beyond that. Public advertising for self-care devices again goes through the Keuringsraad.

Medicines: market authorization, product information, and sharp advertising limits

Medicines are the only category allowed to make explicit therapeutic claims, but solely within the limits set at registration. The CBG (Medicines Evaluation Board) assesses and registers the product, and records the approved indications, dosage, and warnings in the product information, the SmPC, and the package leaflet. That registered text is the anchor point: a claim falling outside it is off-label and not permitted in advertising. On top of that sits the Medicines Act, which draws a sharp separation between audiences and formats. Public advertising for prescription medicines is prohibited, while advertising for self-care medicines is allowed, provided it's pre-vetted by the Keuringsraad. Every claim has mandatory elements, such as essential product information, and a strict distinction applies between information and advertising. Educating about a disease is allowed, as long as it doesn't shift into promoting a specific prescription medicine to the public. A large part of the craft lies exactly on that boundary.

The CGR: the separate framework for communication toward healthcare professionals

Advertising for prescription medicines toward the public is prohibited, but toward professionals it's allowed, under its own rules. That's the domain of the CGR, the Foundation Code of Conduct for Pharmaceutical Advertising, established in 1998 by industry and the umbrella bodies of physicians, pharmacists, and nurses to prevent improper influence on healthcare providers. The Code of Conduct for Pharmaceutical Advertising is self-regulation with a statutory basis in the Medicines Act, with rulings from an independent Code Committee and an Appeals Committee.

A crucial point is the scope. The code targets advertising and inducements toward professionals authorized to prescribe or dispense medicines, in practice the BIG-registered professionals. That distinction often determines in advance which communication toward whom is permitted.

In substance, this too comes down to the claim. Advertising toward professionals may carry therapeutic claims, unlike toward the public, but solely within the registered indication and in line with the product information. A claim going beyond what the CBG has approved isn't permitted in this channel either. In addition, the claim must be recognizable as advertising, separate from objective information and continuing education. Just as important is the second track: the inducement, the financial and material relationships between companies and professionals. The CGR sets limits on hospitality around meetings, standardizes services and advisory boards, and regulates sponsorship. For anyone shaping a congress activation or continuing education, the code therefore affects not just the message, but also the setting and what you're allowed to offer a visitor. A non-binding advisory opinion beforehand provides certainty here.

Working strategically within the framework: the layered strategy

The framework is strict, but not lifeless. Especially with supplements, a layered strategy pays off. The Claims Regulation allows for a general, non-specific health message, provided it's accompanied by an approved specific claim that substantiates it. That's where the creative room lies: a distinctive, brand-owned top layer that grabs attention, anchored in an authorized claim that holds up legally. A vitality positioning resting on a permitted claim about a vitamin and normal immune function, for example.

The same logic applies to content structure. Where a direct claim isn't permitted, you can set up the information architecture so the consumer arrives at the permitted, substantiated information via a legitimate route. You steer with structure and context instead of with a prohibited claim. And in borderline cases, pre-consultation with the Keuringsraad isn't a sign of weakness but an efficient move: it prevents rejected productions and protects the media budget.

This blog is a general explanation and not legal advice. Review against current regulations and with the Keuringsraad remains necessary per claim.