THE LAUNCH OF LEDACTIN WILL BE DELAYED
Due to regulatory issues from the Swedish Medical Products Agency, the launch of Ledactin in Norway and Sweden will be delayed.
The dietary supplement Ledactin is a milk protein concentrate with a standardized content of micronutrients, immunoglobulines and antibodies, all of which can be found in unprocessed milk from cows. The milk that is used to produce Ledactin comes from cows that are kept outdoors on green New Zealand grass all year around, something that further contributes to the content of the milk in a positive way.
Ledactin is the Swedish trademark for the product Microlactin, which today is sold as food or dietary supplement in 15 countries including the US. The American FDA (Food and Drug Administration), which is the agency responsible for the same areas as the Swedish Medical Products Agency (MPA) and the National Food Administration together, has issued a so-called GRAS approval (Generally Regarded As Safe) for Microlactin as a food and dietary supplement.
In SCN’s opinion, Ledactin is clearly defined as food or dietary supplement. However, the Swedish MPA wishes to evaluate the future status of Ledactin in Sweden, and it might take a few weeks before a decision is reached.
In parallel, SCN has started the registration process for Ledactin under the common European standard Novel Food, to secure future access to markets for advanced functional food.
SCN has estimated a sales volume for Ledactin of SEK 4.5 million during 2007.
More information:
Ulf Söderberg, CEO, ulf.soderberg@scnutrition.se, +46 708 13 22 81
Dan Edwall, Director of Research, dan.edwall@scnutrition.se, +46 707 98 80 89
Scandinavian Clinical Nutrition AB (publ) works in R&D and sales of scientifically documented products within the field of nutrition (nutraceuticals). Established in 2006, SCN maintains a product portfolio with established trademarks, such as CUUR, Membraseven and Ledactin. Core competence and strategic alliances, within both R&D and sales, in combination with innovative and scientifically documented products, create the right conditions for profitable growth both in Sweden and on the company’s export markets. The SCN share is listed for trade on NGM Nordic MTF since December 6, 2006.