**3. Regulations of functional foods**

The health benefits of food have always been a subject of discussion from ancient times. While most initial claims regarding the disease-preventing attributes of foods lack scientific evidence, foods such as green tea have been extensively investigated for their health promoting role. The modern concept of functional foods was born in Asia, and Japan was one of the earliest countries to fund research for the systematic analysis and development of functional foods. Research in the recent past has clarified that food can be designed not just to meet primary functions, but also to adjust the human body's homeostasis so as to regulate health and wellness. This idea of physiologically relevant functional foods led to the



*Disease Modifying Potential of Functional Foods for Neurodegenerative Disorders: Status Update… DOI: http://dx.doi.org/10.5772/intechopen.97546*

#### **Table 2.**

*Table depicts a list of the countries along with their functional food regulatory acts.*

formulation of the Japanese regulatory systems. The label and labelling information such as the nutrient content or health claims, accompanying the product would be a primary determinant of its regulatory status. Thus, if the label claims that the

product is intended for use in diagnosis, cure, mitigation, treatment, or prevention of a disease, it would be regulated as a 'drug'. However, if the claim relates to any alteration of the structure and function of the body, with no specific reference to a disease it would be regulated as a dietary supplement [125].

One of the earliest regulatory guidelines was established by the Ministry of Health and Welfare in Japan under a policy termed 'Food for Specified Health Use (FOSHU), under which health claims for few selected functional foods was made legal (The Nutrition Improvement Law Enforcement Regulations, (1996)). The repertoire of functional foods has now expanded to include over 800 FOSHU products [92]. Following the Japanese example several countries have scripted regulatory guidelines for the health enhancing claims of functional foods and nutraceuticals. Nevertheless, regulations for functional foods have not been well established in most countries. Also, the legislations widely vary from country to country.

In the Indian context, the Food Safety and Standards Authority of India (FSSAI) under the Ministry of Health and Family Welfare, Government of India, has framed the guidelines and regulations for health supplements, nutraceuticals, foods for special dietary use, foods for special medicinal purpose, functional foods and, novel foods. The quality requirements and general monograph for such foods are defined in the Indian Pharmacopoeia, which provides guidelines on the usage of food coloring agents, flavours, quantity of nutrients to be added as per Indian Council of Medical Research (ICMR) recommended daily allowance. Interestingly, FSSAI clarifies that mere foods such as vegetables, fruits, cereals, legumes, spices, and other plant or botanicals with minimal processing such as cleaning, de-husking, de-weeding, sorting, drying, or powdering, cannot be considered as 'health supplement', 'nutraceutical', 'food with special dietary use', or 'food for special medical use'. However, the formulation of articles of food must be based on the principles of medicine of nutrition and must be supported by validated scientific data, wherever applicable. More importantly, the label and or leaflet must specify details including the specific use, intended target consumers, the physiological or disease conditions which they address, recommended duration of usage etc. [126].

A list of the countries along with their regulatory acts has been provided in **Table 2**.

#### **4. Conclusion**

Age related neurodegenerative disorders pose a serious healthcare challenge to the medical fraternity worldwide. This is a cause for concern, particularly because symptoms are evident largely during advanced stages of the disease. Presently available monotherapy and pharmacotherapy only provide symptomatic relief. Hence there is an urgent need for improved therapeutic approaches. Also, currently available pharmaceuticals are not free from adverse effects. Therefore, the world is now embracing natural sources as health promoting and disease modifying agents. Towards this objective, the use of nutraceuticals and functional foods is on the rise (**Figure 1**). While several scientific reports prove their neuroprotective functions, extensive clinical validations are lacking. Further, while some functional foods and foods for medical purposes have been evaluated by preclinical and clinical studies, the regulatory guidelines for their labelling and use are still evolving. Increasing awareness among consumers has brought the functional food market to the forefront. It is hence inevitable for authorities to formulate regulatory guidelines with respect to their labelling and usage. While some countries worldwide have put forth *Disease Modifying Potential of Functional Foods for Neurodegenerative Disorders: Status Update… DOI: http://dx.doi.org/10.5772/intechopen.97546*

#### **Figure 1.**

*Neurodegeneration, Physiological Effects, and Functional foods. Image indicates the various physiological dysregulations observed during neurodegeneration (outer circle) and an illustration of functional foods which positively modulate these effects (inner circle).*

legal guidelines, many more are lagging. In addition, a unified set of guidelines across nations is absent.
