By Akshay Kumar, Muhammad Salman Chukkan and G.Vigneshwaran


A standard definition of functional food is needed to facilitate greater communication between food experts and non-experts, scientists, government officials, and the public. This will enable free exchange of functional food products between countries. There are several consequences of leaving the definition of functional food open-ended. For instance: Scientific groups distorting the meaning of functional foods, public confusion created by ambiguous food labels, and the subsequent loss of functional food’s scientific legitimacy among consumers and government officials. As professionals in this field, it is imperative that we clarify what we mean by “Functional Foods,” “Nutraceuticals,” “Medicinal Foods,” and other terms. Because these compounds have the potential to prevent, manage, and treat illness on a global scale, functional food scientists must unite and agree upon a new formal definition for functional food.

Let’s look into two different definitions of functional foods.

  1. “Any modified food or ingredient that may provide health benefits beyond the traditional nutrients it contains”- National Academy of Science, Food and Nutrition Board US.
  2. “Substances that provide essential nutrients often beyond quantities necessary for normal maintenance, growth, and development, and/or other biologically active components that impart health benefits or desirable physiological effects” – Institute of Food Technologists.

Now, you may feel the importance of a simple and common definition, right? In simple words, any food which provides benefits beyond the basic nutrition and may play a role in reducing or minimizing the risk of a certain disease. Example: Omega-3 Fatty acid-enriched Bread is a functional food.

Regulations of Functional Foods in India

In India, Food Safety and Standards Authority (FSSA), defines “Functional Foods”. This definition made to address the poorly regulated segment of Functional Foods and Nutraceuticals. Functional food is a very grey area wherein which there is no clear-cut definition. The definition given in Section 22 can create a big room for confusion.

So, in order to simplify, if any ingredients from Schedule-VI of  Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food, and Novel Food) Regulations, 2016 added to food then it can be termed as a functional food.

Section 22 (Chapter IV) addresses functional foods

  • As per the FSS act, the composition of these foodstuffs must be different from the equivalent ordinary foods. These foodstuffs may contain plants or botanicals or their extracts; vitamins or minerals or their compounds; proteins or amino acids; animal origin substances; or a dietary substance for supplementation of the diet.

Regulations in US

Current US food regulations do not specifically address functional foods but, rather, include them in several categories within conventional foods, food additives, dietary supplements, medical foods, or foods for special dietary use. All of these falls under the category of amended Federal Food, Drug and Cosmetic Act (FDCA) of 1938 and are implemented under regulations from the Food and Drug Administration (FDA).

European Union (EU) regulations

In EU food law, a regulatory framework for ‘functional foods’ does not exist. According to EU regulations, claims regarding the beneficial effects of functional foods only be“health claims” and not “medicinal claims”. For instance, claims must not state that by eating/taking the functional food, disease will be prevented or cured, only that it may help to improve health, possibly assisting in the avoidance of the onset of illness.

The regulatory frameworks of PARNUTS (foods prepared for particular nutritional purposes) or dietetic foods and food supplements may be applicable to some ‘functional foods’. The Novel Food Regulation applies to ‘functional foods’ that are ‘new’. The regulations are governed by the European Food Safety Authority (EFSA).

Regulations in Canada

In Canadian regulations, functional foods come under the category known as “Natural Health Products,” as per “The Natural Health Product Regulations” introduced in “2004” by Health Canada. The law is governed by the Food and Drugs Authority of Canada.

Regulations in Japan

Japan is the pioneer nation in the area of regulating functional foods. The concept of Foods for Specified Health Use (FOSHU) was established in 1991. Foods identified as FOSHU, must be approved by the Ministry of Health and Welfare after the submission of comprehensive Science-based evidence to support the claim for the foods when they are consumed as apart of an ordinary diet. As per the FOSHU Act, functional food can have three functions:

  1. Nutrition
  2. Sensory Satisfaction
  3. Physiological Improvements

Regulations in Australia

In Australia, medicines/func-tional foods are referred to as ‘complementary medicines’ and are regulated as medicines under the Therapeutics Goods Act, 1989, which was implemented in 1991.The law is governed by the Department of Health and Ageing and the definition covers herbal medicines, vitamins and minerals, nutritional supplements, homeopathic medi-cines, aromatherapy products and traditional medicines.

Regulations in South East Asia

No official definition of functional foods in SEA countries except Indonesia. Thereare no harmonized regulations on nutrition labeling and claims in the SEA countries, and no mandatory labeling for general foods in selected SEA countries except Malaysia, In Malaysia as per current national regulations, only mandatory labeling for foods for special dietary use, foods that are enriched or fortified and foods making nutrient claims.


The legal definitions for functional foods are somewhat dissimilar in different countries. For example, in Japan, functional foods are defined according to their use of natural ingredients. In the US, however, functional foods can include ingredients that are products of biotechnology. In India, functional foods can include herbal extracts, spices, fruits and nutritionally improved foods or food products with added functional ingredients. This suggests the requirement of harmonized definition. Harmonized definition helps the consumer, regulatory bodies and Industries. But there are efforts happening around the globe for a standard definition. For example, the definition provided by Functional Food Center, Dallas, USA.“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.”This definition is a wholesome approach that includes the concept of functional food from Japan, USA and other countries.


* Akshay Kumar I, Pursuing LL.B from Government Law College, Kozhikode, Kerala.

Muhammad Salman Chukkan and G.Vigneshwaran, Post Graduate Student, Institute of Chemical Technology, Mumbai, Maharashtra.