The Swedish Market Court has in a recent ruling, case MD 2013:7, considered the marketing of dietary and health products. The Consumer Ombudsman brought an action against a private person selling dietary and health products on the Internet, claiming that the products were medicinal products without the required marketing authorization. It was undisputed that a number of products had been marketed with certain health claims, e.g. relating to increased metabolism, enhanced ability of cells to acquire glucose, cure of tumors, and dissolving of kidney stones. The marketing was considered unlawful.
In accordance with the Swedish Medicinal Product Act (1992:859), every substance that is marketed with statements of preventing or treating diseases, or that may be used for such purposes, shall be considered medicinal products. In its decision, the Court stated that the marketer’s intent may determine if the product is considered a medicinal product or not.
The Court concluded that due to the content of the marketing claims, the products were to be considered as medicinal product. Since no marketing authorization by the Swedish Medical Product Agency had been granted, the marketing was unlawful and therefore unfair in accordance with the Swedish Marketing Act and Annex 1 to Directive 2005/29/ EC (the so called “Black List”). Consequently, the Court prohibited the marketing under a penalty of a fine of one million SEK, unless the necessary marketing authorization was obtained.
Another recent case, MD 2013:6, concerned the marketing of a device for treatment of cellulite. J. Kraft Group AB, brought action against its competitor Leb AB (in liquidation), claiming the marketing to be misleading due to claims regarding the features, performance, price, and medical results. The Court accepted J. Kraft Group AB’s claim.
In this decision, the Court stated that as regards advanced medical and technical information, the requirement on reliability must be set high. For the general consumer, the marketing gave the impression that the product was equivalent to other products on the market, but available at a lower price, and that the use resulted in tighter skin and reduction of wrinkles. As Leb AB had not shown (or even argued) this to be true, the Court held the marketing to be misleading. Consequently, the Court prohibited Leb AB, as well as its sole director and holder of the webpage personally, under a penalty of a fine of one million SEK to use a wide range of claims in the marketing of medical devices for the treatment of cellulite.