Review of Worldwide Regulations and Management Systems for Medical Foods

Enteral nutrition (EN) formulas are foods that are used to improve the nutritional status of patients and these foods' safety and quality must be ensured. Therefore, EN formulas in other countries are managed differently from that of general foods. We investigated the direction of development of the relevant laws regulations and guidelines pertaining to EN formulas and we compared these laws regulations and guidelines from different countries, including Korea. The United States and Europe manage EN formulas as foods, but they are managed differently compared to general foods because of separate laws or programs pertaining to EN foods. In addition, the use of the formulas does not necessarily require a prescription, but when used by prescription, then medical insurance covers them. In Japan, there are two types of EN formulas, food and drug, and there are differences for their management and insurance coverage. In the case of Korea, EN formulas are classified as food and drug, and different management and insurance are applied in each case, which inhibits their systematic management and industrial development. Integration of a management system and establishment of a legal foundation is necessary for the systematic management and development of EN formula in Korea.

Attenuation of RANKL-induced Osteoclast Formation via p38-mediated NFATc1 Signaling Pathways by Extract of Euphorbia Lathyris L

BACKGROUND: Osteoclasts are the only cell type capable of breaking down bone matrix, and its excessive activation is responsible for the development of bone-destructive diseases. Euphorbia lathyris L. (ELL) is an herbal plant that belongs to the Euphorbiaceae family. This study investigated the effects of the methanol extract of the aerial part of ELL on receptor activator of nuclear factor-kappa B ligand (RANKL)-induced osteoclast formation and signaling pathways. METHODS: Osteoclasts were formed by co-culturing mouse bone marrow with osteoblasts or by culturing mouse bone marrow-derived macrophages (BMMs) with macrophage colony-stimulating factor (M-CSF) and RANKL. Bone resorption assays were performed using dentine slices. The expression level of mRNA was analyzed by real-time polymerase chain reaction (PCR) or reverse transcription (RT)-PCR. Western blotting assays were performed to detect the expression or activation level of proteins. RESULTS: ELL inhibited RANKL-induced osteoclast formation without cytotoxicity. Furthermore, the RANKL-stimulated bone resorption was diminished by ELL. Mechanistically, ELL blocked the RANKL-triggered p38 mitogen-activated protein kinase (MAPK) phosphorylation, which resulted in the suppression of the expression of c-Fos and nuclear factor of activated T cells (NFATc1). In osteoblasts, ELL had little effect on the mRNA expression of RANKL and osteoprotegerin (OPG). CONCLUSIONS: The present data suggest that ELL has an inhibitory effect on osteoclast differentiation and function via downregulation of the p38/c-Fos/NFATc1 signaling pathways. Thus, ELL could be useful for the treatment of bone diseases associated with excessive bone resorption.