The Court of Justice of the European Union (ECJ) will soon decide on the issue of whether the restrictions on promoting foodstuffs with nutrition and health claims also apply to communications addressed exclusively to health care professionals (HCPs).

Facts of the Case

The German company Innova Vital GmbH (Innova Vital) distributes the food supplement “Innova Muslin Vitamin D3.” Innova Vital promoted its food supplement with a letter directed exclusively to physicians. The letter contained the following claims:

·         “As already described in various studies, vitamin D contributes essentially to the prevention of various diseases, as e.g., ‘atopic dermatitis,’ and/or ‘diabetes mellitus’ and/or ‘MS.’”

·         “According to these studies, too low vitamin levels at child age are responsible for the later occurrence of these diseases.”

·         “Quicker prevention or elimination of deficiencies (vitamin D3 deficiency at 80% of the population in winter described).”

The claimant, a German competition association, challenged these claims. According to the competition association, these claims violate Article 10 paragraph 1 of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods,¹ as these claims are not authorized in accordance with Article 13 of Regulation (EC) No 1924/2006. In addition, they contend that the promoted effect cannot be proven in accordance with Article 5 paragraph 1 of Regulation (EC) No 1924/2006. The claimant therefore requests that Innova Vital desist from promoting the food supplement with the aforementioned claims.

Innova Vital argues that the restrictions of Regulation (EC) No 1924/2006 do not apply to the challenged advertising claims since the letters were addressed exclusively to physicians. According to Innova Vital, Regulation (EC) No 1924/2006 does not apply to advertising directed solely to HCPs.

The question of whether Regulation (EC) No 1924/2006 applies both inside and outside the professional sector has not yet been decided by the superior courts. Landgericht München I (District Court of Munich I), the court seized, therefore referred the question to the ECJ.

Question Referred

With the decision of December 12, 2014, Case 33 O 5430/14, the Landgericht München I referred to the ECJ the question of whether Article 1(2) of Regulation (EC) No 1924/2006 must be interpreted as meaning that the provisions of that regulation apply 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.

Comments

The ECJ will likely decide that the restrictions of Regulation (EC) No 1924/2006 also apply to claims directed solely at HCPs. The general objective of the regulation, which is to guarantee a high level of consumer protection, would be undermined if promotions directed at HCPs fell outside the scope of the regulation. Since HCPs regularly act as information intermediaries and issue recommendations regarding certain products to consumers, any information provided to HCPs may also affect consumers. In addition, if the legislator had wanted to establish different standards and regulations for nutrition and health claims directed at HCPs than for nutrition and health claims directed at consumers, it could have explicitly done so (as it did in its regulations applicable to the promotion of medicinal products). Finally, Regulation (EC) No 1924/2006 explicitly names the professional sector in Article 11, where it is referred to as “national associations of medical, nutrition, or dietetic professionals and health-related charities.”

On the other hand, according to Article 1 (2), the regulation does not apply to foods delivered to HCPs. One could argue that the regulation similarly should not apply to commercial communications to HCPs. Further, if the restrictions of Regulation (EC) No 1924/2006 apply to advertising directed exclusively at the professional sector, it would be very difficult for the industry to meet the professional sector’s specific information needs. Either way, the decision will have a major impact on the advertising of foodstuffs.

Authors: Ulf H. Grundmann, Partner, Frankfurt a. M., +49 69 257 811 400, ugrundmann@kslaw.com, Elisabeth Kohoutek, Associate, Frankfurt a. M., +49 69 257 811 401, ekohoutek@kslaw.com.

¹ Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December, 2006 on nutrition and health claims made on foods; OJ 2006 L 404, p. 9, available at http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32006R1924&qid=1448443205719&from=EN.