Friday, February 10, 2012: 04:09:52 PM


The Function of Food

A glimpse into the myriad regulations that govern the world of food and nutrition

The concept of the word ‘food’ is no longer limited to the simple definition of ‘something that we eat’. Research now proves that apart from being the primary source of sustenance, certain foods have disease preventive and curative properties. The growing scientific understanding about the role of food, has led to its categorisation so that types of food can be regulated. These categories are regulated differently in different countries. Based on the range of food stuffs and even ‘product specific’ categories, there are ‘health claims’ that are made by regulatory bodies. However these vary from country to country. The health claim is different from nutrition content claim or nutrient function claim and in many countries, falls into a grey regulatory area between food and medicinal claims.

The Occidental Rules:

European Union
The European Commission Regulation on nutrition and health claims made on foods is receiving lot of attention as this legislation requires investment in clinical studies. At present the current legislation is very prescriptive and once implemented by 2010, will allow the industry to use only nutrition claims, whereas health claims have to be from a list of approved claims. Health claims are divided into two groups legally. These claims are different from medical claims like prevention, treatment or cure of disease. Medical claims cannot be made unless the food is approved as a medicine. A new approval procedure for food additives, food enzymes, food flavourings and sources for food flavourings will be adopted very soon in the EU. The EU PASSCLAIM project (Process for Assessment of Scientific Support for Claims on Foods) facilitates academics, industry, consumer groups and regulators, means to evaluate the scientific basis for health claims.

EU-specific Regulation on Novel Foods:
  • Specification on origin, composition and identification
  • Effect due to processing, use of organism, if any
  • Intended and non-intended effects on host metabolism and physiology
  • Analysis report on stability and allergenicity information
  • Evaluation of impact of the introduction of novel food on consumption patterns, possible changes in diet
  • Information on effects of total or partial exposure of humans to novel foods

The Federal Food, Drug and Cosmetic Act (FFDCA) does not provide a statutory definition of functional foods. Attempts to define functional foods include reference to the activity of adding or increasing the health benefit of some kind of a particular food. Functional food is regulated as conventional foods by FDA and hence, falls under general provisions of the Federal Food, Drug and Cosmetic Act that apply to all foods. In marketing these foods, manufacturers may fall under one of existing regulatory options. A functional food can be regulated as a conventional food, a food additive, dietary supplement for food, for special dietary use, depending on how the manufacturer chooses to market the product and type of claims used on the package label.

In Canada, Health Canada regulates the functional foods and also the Canadian Food Inspection Agency enforces these regulations. The term ‘health claim’ is not defined here as well. Food as defined in Food and Drugs Act “includes any article manufactured, sold or represented as food or drink”. Strict directives and regulations governing approval and packaging of products are given in Canadian Food and Drugs Act (CFDA) and are regulated under Natural Health Products Regulations. The legal status of foods and the way they are regulated depends on health claims.

The Oriental Rules

The concept of using foods as health supplements are clearly dealt with in ‘Ayurveda’, and many products are prescribed in Indian traditional medical practice. These are available to consumers directly as over-the-counter (OTC) drugs without medical prescription. Labelling and strict control over formulations and branding are not required for most products. The functional foods or novel foods are dealt in section IV of the New Food Safety and Standards Act, 2006. These products will be approved by special scientific panel. The framework for regulation are given in the new Act. According to the Act, foods for special dietary uses or functional foods or nutraceuticals or health supplement means— foods that are specially processed to meet particular dietary requirement due to specified disease / disorder and the composition of this product may differ significantly from composition of ordinary food comparable by nature. These products cannot claim to cure or mitigate any disease or disorder in the label except for certain health benefits as may be permitted by the regulations made under this Act.

Japan has the most developed market for functional foods. The Japanese Ministry of Health, Labour and Welfare (MHLW) initiated world's first policy of legally permitting the commercialisation of selected foods in terms of Food for Specified Health Use (FOSHU). In April 2001 MHLW enacted two regulatory systems, ‘foods with health claims’, which is the existing FOSHU system and newly established Foods with Nutrient Function Claim (FNFC). China In China functional foods are also called healthy foods. Both nutraceuticals and functional foods are part of Chinese traditional diet and are used in Traditional Chinese Medicine (TCM). In 1996 the provision for functional food administration was promulgated by the Ministry of Health (MOH). It is defines foods having special health functions. In China, functional foods can be in 11 formats like capsules, tablet, powder, granule, liquid and food forms. According to new definition, foods with function claims and nutrient supplements are included. The nutrients supplements in this context are products intended to supply vitamins or minerals but not energy to replenish dietary insufficiency or to correct nutrient deficiency or reduce risk of disease.

The central theme of food regularion seems to be that any health claim can be made only on sound scientific substantiation and validation. The global consensus is that the regulatory authority must protect the consumer, promote fair trade and encourage innovation in the food industry.

Dr Kalpagam Polasa, National Institute of Nutrition

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