Report no: 2007: 38
The Norwegian Food Safety Authority decided that, on the basis of the Norwegian Scientific Committee for Food Safety’s (VKM) previous risk assessment (2005), Nutramigen 1 with Lactobacillus rhamnosus GG (LGG) could not be marketed in Norway as medical foods for infants (0-4 months). In addition, they decided to withdraw permission for marketing of Nutramigen 2 with LGG, which is a milk supplement for infants aged between 4 and 6 months with cow’s milk and soy protein allergy.
Mead Johnson Nutritionals appealed against this decision. The Norwegian Food Safety Authority forwarded the appeal from the companies, and asked the VKM Panel on biological hazards and the VKM Panel on nutrition, dietetic products, novel food and allergy, for a new risk assessment including the new data provided in the appeal.
The VKM panels concluded that the newly provided data are not sufficient to support either the suggested beneficial effects, or the safety, of LGG in infant formula and baby foods for children aged between 4 months and 3 years, when the products are intended for daily use.