Legal rules for advertising foods for special medical purposes (FSMPs), with a free initial assessment

Essential for pharmacists and drugstore operators:

“Advertising for Health and Beauty with Legal Certainty”



The practical guide to medicines advertising law and advertising for food supplements, health claims, foods for special medical purposes, medical devices and cosmetics – available from bookshops or Amazon

Advertising for health-related products is subject to particularly strict regulation. Courts impose high standards on health-related claims. Advertising for medicinal products and other remedies, medical devices, food supplements, foods for special medical purposes and cosmetics is also restricted by specific laws and regulations. The risk of cease-and-desist notices and litigation is particularly high for these products. This book explains the current legal position and includes hundreds of examples from case law.

Contents:

• Selection of terms, texts and media
• Advertising with Trademarks
• General principles of competition law, misleading and comparative advertising, advertising prices and discounts
• Search engine optimisation and search engine advertising, social media and influencer marketing
• General requirements for health-related advertising
• Prohibitions and restrictions under medicines advertising law
• Advertising for medicinal products, pharmaceutical price controls, and advertising discounts and benefits
• Advertising medical devices
• Advertising food supplements, especially HEALTH CLAIMS
• Advertising for foods for special medical purposes
• Advertising for cosmetic products

Back to table of contents

1st edition, November 2024, 408 pages, XchangeIP Verlag, available from bookshops or Amazon

ISBN 978-3-00-079406-3

The Legal Definition of “Foods for Special Medical Purposes”

Under the statutory definition in Article 2(2)(g) of Regulation (EU) No 609/2013, foods for special medical purposes are

“Under medical supervision”

For non-prescription products, a statement that a product should be used only under medical supervision does not generally prevent it from being advertised as a food for special medical purposes. It is by no means certain that consumers will consult a doctor before taking a non-prescription product, particularly when it is advertised for a broadly worded intended use (see Higher Regional Court of Cologne, judgment of 28 February 2024 – 6 U 102/23 – Dietary food for heart disease).

“dietary management”

“Dietary management” refers to a need caused by a disease, disorder or complaint that patients must meet through their diet. The purpose of a food for special medical purposes is not limited to addressing digestive difficulties. Rather, such a food may also be intended to support intake, absorption, metabolism or excretion. Whether the benefit of “dietary management” occurs during digestion is irrelevant to whether a product qualifies as a food for special medical purposes. It may also be designed to compensate for mechanical or neurological impairments that prevent patients from consuming enough food (CJEU, 2.3.2023 – 760/21 – Kwizdi Pharma/Landeshauptmann).

„Other medically determined nutritional requirements“

Specific nutritional requirements due to illness

A specific nutritional requirement resulting from a medical condition means that an illness creates an increased or specific nutritional need that the food is intended to meet. It is not enough that consuming the food is generally beneficial to the patient because substances it contains alleviate the condition or its symptoms. A food for special medical purposes must instead meet the nutritional requirements arising from a specific disease, disorder or medical condition (CJEU, 27 October 2022 – C-418/21 – Orthomol/Verband Sozialer Wettbewerb).

A product’s positive effect on health must not be merely incidental. Rather, the nutrients contained in the product must specifically help address the nutrient deficiency caused by the disease, disorder or complaint.

Indication of the product

The product’s indication is decisive in the first instance. The intended use of a food for special medical purposes must be clearly specified. Even an overly broad umbrella term may mean that a product cannot be marketed as a food for special medical purposes and therefore cannot be advertised as such.

Example (Higher Regional Court of Cologne, judgment of 28 February 2024 – 6 U 102/23 – Dietary food for heart disease) A product was advertised with the claim:

“T. complex is a nutritionally complete food for special medical purposes containing potassium, magnesium, folic acid, vitamin B12, niacin and coenzyme Q10 for the dietary management of heart disease, particularly cardiac arrhythmias.”

The umbrella term “heart disease” was far too broad. “Heart disease” covers a wide range of conditions with different symptoms and needs, including coronary artery disease (CAD), angina, tetralogy of Fallot, myocarditis, pericarditis, heart attack and various heart valve defects. These conditions give rise to different nutrient requirements. A product advertised in this way may not be marketed as a food for special medical purposes. For the same reason, advertising it was also unlawful.

A nutrient deficiency is not itself a disorder

In cases of nutrient deficiency, the cause-and-effect relationship must be considered: the disease or disorder must give rise to the increased or specific nutrient requirement, not the other way around. Nutrient deficiency itself is not such a disorder.

“modification of the patient’s diet alone”

Modifying the patient’s diet alone is not sufficient if the patient either cannot, or can only with great difficulty, change their usual diet, or if the patient can only with great difficulty meet their nutritional needs by consuming ordinary foods (Court of Justice of the European Union, 2 Mar 2023 – 760/21 – Kwizdi Pharma/Landeshauptmann).

Whether a product is intended for the dietary management of patients whose needs cannot be met by modifying their normal diet alone also depends on whether dietary supplements available on the market can meet any nutritional requirements in question. If they can, this suggests that the product is not a food for special medical purposes (Higher Regional Court of Celle, 26 October 2020 – 13 U 44/20 – Marketing a product containing the active ingredient curcumin as a “food for special medical purposes” (Ashwagandha)).

“Nutrients”

The definition of nutrients is based on Art. 2(2)(s) of the Food Information Regulation (CJEU, 2 March 2023 – 760/21 – Kwizdi Pharma/Landeshauptmann). Accordingly, nutrients are proteins, carbohydrates, fat, fibre, sodium, vitamins and minerals listed in Annex XIII, Part A, No. 1 of the Regulation, as well as substances belonging to or forming part of one of these classes. Bacteria are not nutrients.

Example (BGH, 13 July 2023 – I ZR 68/21 – bacterial cultures) A product “for dietary management” of irritable bowel syndrome (IBS), ulcerative colitis and pouchitis (UC), atopic dermatitis (ATOP) and symptomatic uncomplicated diverticular disease (SUP) contains viable bacterial cultures, naturally found in the human gut, in capsules. Such products are not foods for special medical purposes because they do not meet a nutritional requirement.

Key considerations when distinguishing foods for special medical purposes from medicinal products

Distinguishing food for special medical purposes from medicinal products by presentation

Foods for special medical purposes may also be classified as medicinal products, in which case they are subject to medicines law (on the general distinction between foods and medicinal products).

As a rule of thumb, a food for special medical purposes is intended to nourish a patient, while a medicinal product is intended to cure a patient. A distinction must be made between nutrient requirements resulting from a disease and the disease itself. A product that promises to treat the disease itself is not a food for special medical purposes, but a medicinal product.

Permitted mandatory information on diseases

However, foods for special medical purposes are subject to certain specific requirements. Under Article 11(1)(c) of Regulation (EU) No 609/2013 on foods for special medical purposes, in conjunction with Annex I to Article 4 of Delegated Regulation (EU) 2016/128, foods for special medical purposes must be designated as such, namely as

„Food for special medical purposes (dietary food for special medical purposes)“.

Under Article 5 of Delegated Regulation (EU) 2016/128, foods for special medical purposes must include various mandatory statements referring to a disease, disorder or medical condition. For example, the following statement is required:

“For the dietary management of …”,

supplemented by the disease, disorder or complaint for which the product is intended, or by a statement that the product must be used under medical supervision. Such mandatory statements do not imply that the product is a medicinal product and do not classify it as a medicinal product by presentation.

Distinguishing food for special medical purposes from medicinal products by function

Furthermore, foods for special medical purposes are not intended to prevent or cure human diseases, restore, correct or modify human physiological functions through pharmacological, immunological or metabolic action, or make a medical diagnosis. Foods intended for these purposes are medicinal products (CJEU, 2.3.2023 – 760/21 – Kwizdi Pharma/Landeshauptmann).

Prohibition on misleading claims or attributing properties that prevent, treat or cure human disease

Under Article 9(5) of Regulation (EU) No 609/2013 on foods for special medical purposes, advertising must provide information on the appropriate use of these foods. It must not be misleading, attribute properties to these products for the prevention, treatment or cure of a human disease, or imply that they have such properties. In particular, under Article 9(1) of Regulation (EU) No 609/2013, the composition of foods for special medical purposes must, in accordance with generally accepted scientific data, meet the nutritional requirements of the persons for whom they are intended and be suitable for them. Advertisers must substantiate their claims with generally accepted scientific data (Article 9(1) of Regulation (EU) No 609/2013 on foods for special medical purposes and Article 2(2) of Delegated Regulation (EU) 2016/128), namely with a randomised, placebo-controlled, double-blind study (see BGH, 15 March 2012 – I ZR 44/11 – ARTROSTAR, applying the former Section 14b DiätV).

Importantly, the evidence must relate to the composition of the product, not just its individual ingredients. However, the efficacy of a combination of ingredients cannot be established without knowledge of interactions between the substances combined. Such interactions cannot be disregarded, because the use of multiple or additional ingredients may reduce the product’s nutritional and medical efficacy, and the effects of individual components may cancel each other out in the body (Higher Regional Court of Celle, judgment of 1 July 2021 – 13 U 21/20 – Dietary treatment of cold sores).

Exceptions: Mandatory disease-related warnings

Foods for special medical purposes are, however, subject to mandatory statements referring to diseases, disorders or medical conditions (see above). The prohibition on misleading consumers does not therefore apply to references to the dietary management of diseases, disorders or medical conditions for which the food is intended (see Recital 25 of the Foods for Special Medical Purposes Regulation).

Disclaimers must comply with the mandatory information requirements

Only claims that comply with the mandatory information requirements are permitted.

Example (OLG Munich, 31.10.2019 – 29 U 2177/19 – Darmbakterien) The statement

“AAD [for antibiotic-associated diarrhoea] Plus”

is not permitted. This is because, pursuant to Article 5(2)(e) of Regulation (EU) 2016/128, the following statement is permitted and mandatory

“For the dietary management of antibiotic-associated diarrhoea”.

Pursuant to Recital 25 of Regulation (EU) 609/2013, this mandatory statement should not be regarded as attributing a property related to the prevention, treatment or cure of a human disease.

Only factual information is permitted

Only claims that provide factual information about whether the product is suitable for use based on its individual characteristics are permitted.

Example (KG Berlin, 25 April 2018 – 5 U 82/17 – unlawful disease-related claims, under former Section 21(1), nos. 1 and 2 DiätV) The statement

“Dr. […] is the only natural remedy for the nutritional medical treatment of urinary tract and bladder disorders (food for special medical purposes), with double the power and a full 75% success rate”,

and

„Successfully tackles bladder problems from two angles“

are not objective descriptions of the characteristics permitted under Article 5(2)(g) of Delegated Regulation (EU) 2016/128, which explain how the product serves its purpose in relation to the disease, disorder or medical condition for which it is intended for dietary management.

Foods for special medical purposes developed to meet the nutritional requirements of infants

Special rules apply to advertising foods for special medical purposes developed to meet the nutritional requirements of infants. Such products may be advertised only in publications devoted to infant care and in scientific publications (Article 8(4) of Delegated Regulation (EU) 2016/128).

Advertising must avoid any risk of confusion between foods for special medical purposes developed to meet the nutritional requirements of infants (definition in Art. 2(1)(c) of Regulation (EU) No. 609/2013 on foods for special medical purposes), infant formula and follow-on formula (definition in Art. 2(1)(d) of Regulation (EU) No. 609/2013 on foods for special medical purposes). Advertising with discounts, free gifts, promotional gifts and samples is prohibited.

Advertising for foods for special medical purposes developed to meet the nutritional requirements of infants must not contain images of infants or any other images or text that could idealise the use of the product. Illustrations may, however, be used to help identify the product and show how to prepare it (Article 8(2), Delegated Regulation (EU) 2016/128).

Author: Thomas Seifried, Lawyer specialising in medicinal product advertising law and Specialist lawyer for intellectual property law