On 14 July 2016, the Court of Justice of the European Union (CJEU) issued its decision in Case C-19/15 Verband Sozialer Wettbewerb v Innova Vital GmbH on the application of the Nutrition and Health Claims Regulation 1924/2006 (“NHCR”) to business-to-business (“B2B”) commercial communications.  The CJEU ruled that B2B communications that were promotional in nature came under the scope of the NHCR even though they are not specifically directed at “the final consumer”.

Background

Innova Vital GmbH (“Innova”) sent a letter exclusively to named doctors advertising its Vitamin D3 food supplement (the “Product”), providing information on its composition and selling price, and claiming the Product contributed to prevention of diseases caused by Vitamin D deficiency. Verband Sozialer Wettbewerb argued the letter was in breach of the NHCR, claiming that the NHCR applied to commercial communications addressed to both the professional sector and general public. Innova argued that the letter was intended only for doctors and that the NHCR did not apply to advertising intended for the professional sector since the scope of the rules applied only to health claims made in commercial communications “delivered as such to the final consumer” (Art. 1(2) NHCR). The Munich I Regional Court referred the following question to the CJEU for a preliminary ruling:

Must Article 1(2) of the NHCR be interpreted as meaning that the provisions of that regulation apply also to nutrition and health claims made in commercial communications in advertisements for foods to be delivered as such to the final consumer if the commercial communication or advertisement is addressed exclusively to the professional sector?

Decision

The CJEU ruled that Article 1(2) of the NHCR must be interpreted as meaning that nutrition or health claims made in commercial communications on a food which is intended to be delivered as such to the final consumer, but exclusively to health professionals, fall within the scope of the NHCR. In reaching its decision, the CJEU made the following observations:

  • The CJEU stated that “commercial communication” within the meaning of Article 1(2) of the NHCR must be understood as covering, inter alia, a communication made in the form of advertising foods, designed to promote, directly or indirectly, those foods.
  • The application of the NHCR to nutrition and health claims made in a commercial communication to professionals contributes to a high level of consumer protection and effective functioning of the internal market which is in line with Article 1(1) of the NHCR. Excluding nutrition and health claims addressed exclusively to health care professionals would result in such claims being used without appropriate scientific evidence and food business operators could circumvent NHCR’s provisions by addressing final consumers through health professionals.
  • Furthermore, the CJEU also held that it was the product itself and not the communication which must be intended for the final consumer.
  • The CJEU admitted that health professionals may be considered as having scientific knowledge superior to that of a final (average) consumer, but stated that health professionals may not always have all specialised and up-to-date scientific knowledge to evaluate nutrition and health claims made on each food. The CJEU further argued that health professionals can have significant influence on final consumers as a relationship of trust generally exists between health professionals and their patients.

Interestingly, in the Advocate General’s Opinion, France pointed out that the claims used in the letter sent by Innova were neither nutrition nor health claims, but rather medicinal claims, therefore falling out of the scope of the NHCR and not permitted to be made on foods. The CJEU did not address this point in its ruling.

This case will have implications for food businesses that include scientific and health/nutrition-related information in their communications with healthcare professionals (e.g., healthcare professional-only websites) and other businesses (e.g., distributors and retailers). Companies should review their B2B communication strategies to ensure that they comply with the NHCR.

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Photo of Brian Kelly Brian Kelly

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union…

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union law, and product liability and safety. The Chambers Europe Guide to the legal profession lists Brian as part of our “world-class [regulatory and public affairs] team and describes him as a notable practitioner who is “very ambitious, thorough with a sharp intellect”. The Chambers UK Guide quotes clients saying: “his communication and work ethic stand out, he is very hard-working and dedicated when it comes to his cases.”

Brian’s advice on general regulatory matters across all sectors includes borderline determinations, food classifications, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, procurement/tenders (including emergency use tenders, EU-wide tenders, Covid-19-related tenders), product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice. Brian has also been advising on UK and European “Brexit” related issues including tariffs. 

Brian has also advised and co-ordinated international projects on advertising/promotion, clinical research, data protection, the regulatory status of borderline products, food/cosmetic ingredient reviews and advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.

Brian is also experienced in representing clients in administrative and enforcement proceedings before regulatory authorities and in the UK and EU courts. 

Brian is an honorary lecturer at University College London.