18 December 2015 | Column | By Dr D B A Narayana,
<p><span>Notification of draft nutraceuticals regulations by the Food Safety Standards Authority in the gazette is expected to open a new chapter in innovations in India in the area of food and supplements</span></p>
Now that the Food Safety Standards Authority have notified in the gazette the draft nutraceuticals regulations it is expected to open a new chapter in innovations in India in the area of food and supplements. Having been a participant contributing scientific and regulatory inputs to the development of this draft regulation, a work which began with the first nutraceuticals summit that was held in Mumbai in 2004 the need for research in this area has been coming up again and again during discussions.
Various organisations in India have been engaged in research related to nutrition, nutritional deficiencies, diet, dietary habits, dietary consumption levels, fortification as a route to deal with deficiencies, bioavailability of nutrients when fed through fortified foods, effect of fortification to reduce or remove problems like stunting, growth, vision, anemia, weight gain, learning and mental abilities are most important areas in which research has taken place.
It is also important to record and recognise that most of these researches have been funded and driven by governmental agencies both national and international. Some of these agencies are National Institute of Nutrition, Indian Council of Medical Research, Central Food Technological Research Institute, National Sample Survey Organisation, United Nations Development Programme (UNDP), United Nations Educational, Scientific and Cultural Organisation (UNESCO), World Health Organisation (WHO), a few Council of Scientific & Industrial Research (CSIR) Labs.
Research related to nutraceuticals, botanicals used as supplements, Probiotics and Prebiotics, enzymes and other ingredients which are covered in the draft regulations, including vitamins, minerals and amino acids are lacking, grossly inadequate and in many cases completely absent. Research related to these ingredients covering objectively assessable quality standards, analytical procedures which can be used to confirm addition/presence of these ingredients to any food format, approaches to study their shelf stability, human intervention studies to evaluate/confirm their health benefits are non-negotiable research areas.
Appreciable work has happened with reference to the quality standards as seen in Indian Pharmacopoeia, United States Pharmacopoeia and British Pharmacopoeia where monographs for quality for over 200 botanicals and their extracts have been published. Such quality specifications are result of focused research and more needs to happen in this area.
Pharmacopoeias were primarily meant and aimed to provide specifications for drugs, and pharmaceuticals. But by providing these standards on botanicals used mostly in nutraceuticals/supplement products pharmacopoeial organisations have contributed a lot in protecting consumer interest in healthcare.
A greater co-operation and working together by authorities of the foods with Indian Pharmacopeia Commission (IPC) would be beneficial to the former as IPC has the necessary skills, competencies and expertise to develop quality standards for botanicals. To that extent foods authority in India should tie up with IPC and fund research to lay down quality standards for botanicals used in supplements.
There are a number of areas of research needed in the emerging nutraceuticals sector. One of the important areas would be to study impact on bioavailability of vi
Research needs for food and supplements
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tamins and minerals when combined with other ingredients listed in the definition under Section 22 of FSSA. Information on compatibility and incompatibility of the most commonly formulated multi-ingredient supplements is totally lacking and needs to be focused on.
The foods authority should consider and earmark funds to sponsor and generate scientific data from research projects which especially provide confidence on the safety and stability of food products and supplements sold in Indian market.
The Foods Act of 2006 is not just an administrative regulation but an all-encompassing Act that looks at safety, standards, risk management and also does not cover ‘products alone’ but the entire gamut of foods area including street foods, foods served in restaurants, eateries, functions and public.
Ensuring microbiological quality in the entire supply change itself is a big research area including need to develop cost effective and safe technologies to reduce bio-burden of foods and ingredients. Contamination control and handling is another area.
It is common to find multi-ingredient supplement products which contain as many as 10 ingredients going up to even 25 ingredients. Whether science leads and decides such complex formulations or marketing decides is a question that has not been studied. Providing good sci
entific rational for combining so many ingredients in one product is seldom seen. Convenience, promoting compliance and sometimes strong marketing positioning statements seem to be the only rational.
Discussions and research is the need of the hour to come up with broad guidelines on whether there is a need to limit the number and type of ingredients in a supplement formulation and if so what should be that number? This acquires high importance as most consumers are likely to take more than one supplement without going into details and may end up consuming a few ingredients at a high combined dose levels.
It is not intended here to data dump by giving figures of the finances spent by many departments of Government of India to sponsor research. Such data is available and the figures are substantial and may need enhancement. However R&D spends on many areas of the above research by foods and supplement industries are not easily available, and where available for a few firms the figures are too meager proportion of the turnover or profit of those companies.
It is common knowledge that firms spend more on marketing, advertisements, a small part of which goes to consumer research (primarily to find out what the consumer wants and how to make them buy their products). R&D spends should be made to be declared as a part of the quarterly statements of accounts and balance sheets.
Human intervention studies to document safety and health benefits of supplements and value added products this sector would see in future should be a thrust area for industry before they make health benefit claims for their products.
Based on the advice of the Chairman of the scientific panel on nutraceuticals of the FSSAI, the panel is discussing these issues and readers of NuFFooDS should send their suggestions on various research areas needed for this sector.
Can we see industry associations and nutrition societies making research needs for the sector as focused theme for their seminars and conferences this year? Development of strategy for research funding by the foods authority should be based on such discussions.