Background: Functional food science has gained momentum recently in response to the changing health status of developed countries. As healthcare costs and average life expectancy rise, the public has sought ways to become healthier and develop higher qualities of life. The concept of “functional food” developed as a convenient and inexpensive solution to chronic health problems, and is becoming influential in numerous branches of science and policy. Since its conception in 1984, “functional food” changed its meaning per country and culture. The term migrated from Japan to the EU and the United States where it generated profit but bred confusion among experts and non-experts. In this chapter, we review how “functional food” has been defined and redefined over the past 30 years, as well as the benefits of our current definition. The goal of this new definition is to strengthen communication between nutrition scientists, the public, and other groups as well as legitimize functional food science around the world.Keywords: Functional foods definition; bioactive compounds; biomarkers

Cardiovascular disease (CVD) is the Nation's leading killer for both men and women among all racial and ethnic groups. Development and progression of CVD is linked to the presence of risk factors such as hyperlipidemia, hypertension, obesity, and diabetes mellitus. It is known that cholesterol is an indicator of increased risk of heart attack and stroke. Low-density cholesterol (LDL) above 130 mg/dl high-density cholesterol (HDL) cholesterol below 35 mg/dl and total blood cholesterol above 200 mg/dl are indicators of problematic cholesterol. Proper ranges of cholesterol are important in the prevention of CVD.It has been suggested that a reduction in the consumption of saturated and an increase in unsaturated fatty acids is beneficial and prevents CVD. Amaranth grain contains tocotrienols and squalene compounds, which are known to affect cholesterol biosynthesis. The cholesterol precursors squalene, lanosterol and other methyl sterols, reflect cholesterol synthesis [1-3], whereas plant sterols and cholestanol, a metabolite of cholesterol, reflect the efficiency of cholesterol absorption in normal and hyperlipidemic populations [4-6].Qureshi with co-authors [7] showed that feeding of chickens with amaranth oil decreases blood cholesterol levels, which are supported by the work of others [8]. Previously, we have shown that Amaranth oil modulates the cell membrane fluidity [9] and stabilized membranes that could be one reason as to why it is beneficial to those who consume it. It is known that in hypertension, the cell membrane is defective and hence, the movement of the Na and K ions across the cell membranes could defective that could contribute to the development of increase in blood pressure. Based on these properties of amaranth oil we hypothesize that it could be of significant benefit for patients with CVD.

The double-blinded placebo-controlled randomized study has been performed in 51 coronary heart disease (CHD) patients to estimate the effects of time-released garlic powder tablets Allicor on the values of 10-year prognostic risk of acute myocardial infarction (fatal and non-fatal) and sudden death, with the respect of secondary CHD prevention. It has been demonstrated that 12-month treatment with Allicor results in the significant decrease of cardiovascular risk by 1.5-fold in men (p < 0.05), and by 1.3-fold in women. The above results were equitable also in terms of relative risks. The main effect that played a role in cardiovascular risk reduction was the decrease in LDL cholesterol by 32.9 mg/dl in men (p < 0.05), and by 27.3 mg/dl in women. Thus, the most significant effects were observed in men, while in women the decrease of cardiovascular risk appeared as a trend that might be due presumably to the insufficient sample size. Since Allicor is the remedy of natural origin, it is safe with the respect to adverse effects and allows even perpetual administration that may be crucial for the secondary prevention of atherosclerotic diseases in CHD patients.

The definition of functional foods (FFs) has been in development for many years by the Functional Food Scientists of the Functional Food Institute/Functional Food Center (FFC). The status of the FFC’s definition is currently unrecognized by the Food and Drug Administration (FDA),but recognition is important for the safe, uniform development and disbursement of functional food products (FFPs) that could improve the health of Americans and people around the world struggling with chronic and viral diseases. If functional foods were to be properly termed using the FFC’s current definition, they would be classified as a drug according to the FDA. Thus, the FFC is in communication with governmental representatives to determine the next steps for functional foods to be properly acknowledged. To that end, the FFC is revising its current definition of functional foods to fit a more accurate and encompassing idea of the nature of what functional foods do. This includes a shift to stressing how functional foods promote optimal health, reduce the risk of chronic/viral disease, and manage their symptoms.Additionally, the process of developing a functional food product must be standardized to ensure the safety of administering bioactive compounds as a health optimization tool. This process follows the methodology of functional food science, which is a potential new form of life science proposed by the Functional Food Center. Over time, the FFC has been developing the appropriate steps to create a functional food product, however, in this article, new steps are emphasized, such as epidemiological studies and after-market research—vital steps to ensuring the safest and most efficacious product is released to the public. Functional foods are not meant to take the place of conventional medicine. They can, however, be used in conjunction with Western medicine and serve as an aid to health optimization for people with chronic/viral diseases and prioritize the management of symptoms associated with those diseases.Keywords: functional foods, bioactive compounds, biomarkers, functional food science, functional food products, epidemiological studies

There has yet to be a consensus on the definition of functional foods (FF), and accordingly many institutions lack a comprehensive process for its classification. The Functional Food Center (FFC) has previously proposed a multi-step process for the development of functional food products and ways by which to bring them to market without means to classify established items. This article is advancing the previously proposed methodology with the addition of new steps. The newest steps focus on themes of transparency by the publishing of peer-reviewed articles for the functional food product as mandatory for accreditation. In doing so, this will provide greater access to information for the functional food market, as well as, acceptance and trustworthiness of functional claims. Additionally, the Functional Food Center has created a new system for categorizing functional foods. The new categorization system uses improved research on epidemiological and after market studies, and evaluates the quality of evidence for the functional food product (FFP) as A, B, or C. A classification of A denotes the completion of aftermarket research, epidemiological studies, and certification of functional food status. Classification B denotes completion of epidemiological studies and certification of functional food status. Lastly, C indicates that the product has only been certified as functional. The Functional Food Center’s definition of functional foods, steps on how to create functional foods, and proposed categorization will help to describe our proposed regulation of FFP.  KEYWORDS: Functional Food Classification, Functional Food Regulation, Functional Food Products, Categorization Grades of Functional Food, How to Create Functional Food, Bioactive Compounds, Functional Food Definition