Let food be thy medicine and medicine be thy food” was embraced 2500 years ago by Hippocrates, the father of medicine. However, this “food as medicine” philosophy fell into relative insignificance, unimportance and non recognition in the 19th century with the advent of modern drug therapy. During the first 50 years of the 20th century, scientific focus was on the identification of essential elements, particularly vitamins, and their role in the prevention of various dietary deficiency diseases. This emphasis on nutrient deficiencies or “undernutrition” shifted dramatically, however, during the 1970s when diseases linked to excess and “overnutrition” became a major public health concern. Recently, scientists began to identify physiologically active components in foods from both plants and animals that potentially could reduce risk for a variety of chronic degenerative diseases. The great majority of these components derive from plants; however, there are several classes of physiologically active functional food ingredients of animal or microbial origin. These events, coupled with an aging, health-conscious population, changes in food regulations, numerous technological advances and a marketplace ripe for the introduction of health-promoting products, coalesced in the 1990s to create the trend we now know as “functional foods.” With the emergence of functional foods, it is vital to explore how the Developed country and its regulations on health claims affect the functional food industry. According to the several definition by many institutions, the modern definition that classifies a functional food is as follows: “Natural or processed foods that contain known or unknown biologically-active compounds; which in defined, effective non-toxic amounts, provide a clinically proven and documented health benefit for the prevention, management, or treatment of chronic disease”. The opportunity to make statements on food labels related to the health benefits of functional foods, it is not surprising that major companies are interested in developing such foods for the health and wellness market. Although the size of the functional foods market is difficult to quantify because much of the data includes other types of health-related products The safety assessment of functional foods follows the same paradigm established for conventional foods consisting of an assessment of the intrinsic hazards associated with the food/food ingredient combined with knowledge about the expected exposure that will occur. Addressing safety concerns on single components is relatively straightforward. However, functional foods can be whole foods and/or may consist of multiple components with increasing complexity which results in a different strategy often being required depending on the type of food/food ingredient. The safety issues related to herbs are complex and the issue of herb-drug interaction has received increasing attention. We need to developed regulations or provided guidance to companies on the type of safety-related information that should be included on their labels for functional foods and dietary supplements. The absence of such safety information poses a significant safety risk to some consumers.”