Regulatory reforms in Nutraceuticals and Nutrition World

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Regulatory reforms in Nutraceuticals and Nutrition World

by admin

by admin


Nutraceuticals and nutrition foods, though popular in other parts of the world, was a new concept in India when FSSAI started functioning on 5th August, 2011. USA, Europe, Japan, China and other developed nations were the only consumer of Nutraceuticals and Health Supplements. It was used mostly by the health conscious consumers who are affluent also.
With passage of time, these products find acceptability among a larger chunk of the health conscious populations. Credit goes to the medical professionals and nutritionists who advocated consumption of nutraceuticals and nutrition products. FSSAI has also notified Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food Regulations,2016. Since the regulations was new not only to the Food Business Operators (FBOs) but also to the Food Safety Officers (FSOs), enforcement of the regulations was effective from 1st January ,2018.
While implementing the regulations, a number of short comings have been noticed and need of the regulatory reforms has been discussed.

Recommended Daily Allowance for Indians (RDAI): 

As per Section 22(1)(a)(II), foods for special dietary uses or functional foods or nutraceuticals or health supplements may contain minerals or vitamins or proteins or metals or their compounds or amino acids ( in amounts not exceeding the Recommended Daily Allowance for Indians ) or enzymes ( within permissible limits ). RDA is different for different countries. USFDA have both minimum and maximum RDA whereas in India, we have no maximum and minimum limits.
Indian Council of Medical Research submitted a report of the expert group in 2010 to update the nutrient requirements and dietary allowance for Indians. FSSAI also adopted the RDAI recommendations of the National Institute of Nutrition – Indian Council of Medical Research (NIN-ICMR), Hyderabad.
Quantity of nutrients added to the articles of food shall not exceed the RDAI as specified by the ICMR and in case such standards are not specified, the standards laid down by international food standards body, namely Codex Alimentarius Commission, shall apply.
A nutraceutical which is not provided in these regulations, shall be manufactured or sold in India only on prior approval of the FSSAI which shall be accompanied by documented history of usage of at least fifteen years in India, or thirty years in the country of origin.

Need for Regulatory reforms

In the last few years, there have been tremendous growth of Health Supplements and Nutraceuticals business all over the world. A number of new ingredients / products have been found to be very effective on health related issues. Also, the present level of RDAI of ICMR appears to be insufficient to give desired effect.
NIN – ICMR conducted study to revise the RDAI. Meanwhile, they have submitted a report on Tolerable Upper Limit (TUL) for vitamins and minerals. FSSAI also issued a circular on TUL. However, Section 22(1)(a)(II) of the FSS Act, prohibits the use of more than one RDAI, TUL is of no help unless the FSS Act is suitably amended .
FSSAI also notified 400 botanical ingredients in Schedule IV of the regulations, which can be used as an ingredient in health supplements and nutraceuticals. For approval of any ingredient which is not specified in Schedule IV, application along with fees of Rs 50,000/ plus safety studies and regulatory status to be submitted to the FSSAI. Since some of the ingredients/products do not have documented history of use of 30 years in the country of origin, these are not allowed by the FSSAI. Even if these are available, FSSAI insists clinical trial of these products on Indian population which is time consuming and costly affair for the food business operators.
During the present COVID-19 Pandemic situation, a number of health supplements and nutrition products have been found to be effective immunity booster in overseas countries. But these products are not allowed by the FSSAI as these products have ingredients with higher RDAI. As per existing ICMR guidelines, RDAI for vitamin C is 40mg and zinc is 12 mg whereas most of these immunity booster contain 500/1000 mg vitamin C and 50 mg zinc.

Joint Parliamentary Standing Committee Report:
Department – related Parliamentary Standing Committee on Health and Family Welfare, presented 110th report on “Functioning of Food Safety and Standards Authority of India ” on 9th August, 2018 to the Rajya Sabha and Lok Sabha.
As former Director, FSSAI, I was an invited member and submitted my suggestions, most of which were considered and included in the report. The committee learnt about Health Supplements and Nutraceuticals regulations of the FSSAI.
The committee recommended that FSSAI should systematically evaluate the performance of the FSS Act, it’s rules and regulations. Amendments required in the FSS Act were also recommended.

Proposed Amendments of the FSS Act
Ministry of Health and Family Welfare, Government of India, vide its public notice of September 23, 2020 invited comments and suggestions on the proposed FSS ( Amendment  ) Bill, 2020.
It has been suggested that under Section 22(1)(a)(II) of the FSS Act, “in amounts not exceeding the Recommended Daily Allowance for Indians” to be deleted and replaced with by TUL as now it is officially determined by NIN-ICMR too.
All derivatives, salts, chelates, esters and related forms of vitamins and minerals mentioned in Schedule I of the Health Supplements, Nutraceuticals regulations may be used. Methylcobalamin, L- Methylfolate shall be included under vitamins as well as in the respective Schedule I and Schedule VI.
There is an urgent need to amend the regulations, particularly to allow novel food/ingredient which will be manufactured under the Prime Minister’s “Make in India” programme. In a rapidly changing world, we should not wait for documented history of usage of at least fifteen years in India, or thirty years in the country of origin. This condition should be deleted.

Regulatory reforms is a continuous process. Procrastination in granting approval of novel food/ ingredient hampers the economy of the country. Scientific evolution should be encouraged to boost the Health Supplements and Nutraceuticals industry which offers enough scope not only for domestic markets but also export.

The article has been written by Mr. Pradip Chakraborty (Former Director of FSSAI) and published by Interlink Insight Vol 19 issue 2. 

About Author: Pradip Chakraborty, Former Director, FSSAI

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