Potential health benefits of lactoferrin and derived peptides - how to qualify as a medical device?

Abstract

ABSTRACTsLactoferrin (LF) is a glycoprotein, a member of the transferrin family, and is present in a variety of secretory fluids, including milk, saliva, tears, and mucosal secretions. Iron binding, immunological regulation, antibacterial action, and intestinal nutrition absorption are only a few of its important biological roles. Although much research has been done on human lactoferrin (hLF), LF derived from different animals is equally essential for physiology and health. Depending on the intended application and mechanism of action, goods containing LF and its peptide derivatives may be classified as medical devices under FDA rules or EU Directives. For EU and FDA regulations, a product may be categorized as a medical device if it primarily provides antimicrobial or health advantages. However, LFs are not considered as medical device when used as a food addition or supplement without particular medicinal claims. Safety and efficacy data are examined for regulatory approval in this category to guarantee its appropriate usage and usefulness in clinical settings. When utilized in various medicinal applications, including wound healing, gastrointestinal problems, and immune system stimulation, the complex nature and potential health advantages of LFs and their derivatives would be consistent with their categorization as a class II medical device. The role of LFs of several species (especially cameloids) is discussed in this paper as biological products with particular biological activities and intended medical applications, where LF satisfies the requirements to be classified as a class II medical device.