Month: April 2021

Introduction: 

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.

Conclusion
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
Email: pradipchakraborty91@yahoo.com

With escalating awareness about Preventive care and health consciousness, Nutraceutical market is growing at a rapid pace in today’s world. The market worth more than $382.5 billion this year and it is expected to reach the market value of $722.4 billion by the end of 2025. Looking at the annual growth rate, in my opinion, Nutra market surely willmake impressive business in upcoming years.

Although the market is expected to strike gold in near future, the regulatory landscape of this sector is emerging as a ‘holding back factor’ for market’s growth. The Nutra regulatory system seem to evolve very slowly compared to the growing number of products being placed into the market. Looking at therisk of fake and unregulated product, market today is asking for strict regulation measures in this field. Being in the grey area between diet and drugs, it is important to clearly identify their specificity in view of their possible use and utility in the pharmaceutical arena.

Drawbacks in Nutra Regulatory framework:

1. No legally globalized definition:
The word ‘Nutraceuticals’ is coined by Stephen DeFeliceand according to him, Nutraceutical is “food or part of a food that provides medical or health benefits, including the prevention and/or treatment of a disease”. This was the basic definition available for nutraceuticals but is every country following the same definition? Absolutely not! Canada refers to nutraceuticals as “natural health products” while the United States calls them “dietary supplements.” So, while setting up a Nutra-marketing campaign in any particular country, finding a right legal definition used in that country becomes a greatest concern to reaches the right audience and avoids confusion. CHART 1 is consisting of definitions of various nomenclatures of Nutraceuticals in some major countries.

2. No uniformity in Regulations:
The lack of shared legislations around the world creates a big confusion while marketing Nutraceutical products worldwide. Proper understanding about the regulations and active regulatory bodies is mandatory for effective marketing. For example, according to Dietary Supplement, Health and Education Act (DSHEA) in US, a dietary supplement should be “a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamins, minerals, amino acids, herbs or other botanicals; a concentrate, metabolite, constituent, extract or combination of the ingredients listed above.” Likewise, in other countries, the formula requirements for the Nutraceutical product might be much different than stated above. Same goes for labelling requirements, they also should be properly studied for the respective country before marketing.

3. Unsubstantiated health claims:
Lack of safety, efficacy and scientific data are the main hurdles while obtaining health claim approval for Nutraceutical products. Nutraceuticals generally are tested only in invitro studies whose evidences are pretty unreliable to comment on thesafety of product. Nutraceuticals are lagging far behind in the field of In vivoresearch, which are obligatory to pass any health claim. Scarcity of regulations in this field to hold back the false claims is still worsening the condition of regulatory landscape.
So, while marketing any Nutraceutical, to protect the sales and credibility of the company, care has to be taken that it should not be marketed as a ‘drug’ (because drugs undergo heavy research and in vivo studies to achieve the health claim).

             CHART 1

4. Lack of Good manufacturing practices:
According to Nutraceuticals World, recent FDA GMP inspections indicated that a good number of dietary supplement manufacturers are not fully compliant with GMPs. Noncompliance with the specifications for ingredients as well as for finished product were investigated. Common violation in this field is failure in verifying purity, identity, composition and strength standards of product batch. This is the major concern seen in the Nutraceutical sector for years.

Owing to all such regulatory deformities, full export potential of Nutraceutical sector cannot be achieved which could be a serious issue with respect to country’s economic status. Sanjaya Mariwala, founder-president of the Association of Herbal and Nutraceuticals Manufacturers of India said, “The governing ecosystem for nutraceuticals needs a serious rethink along with clarity on defining the scope of the sector and its product portfolio. The need of the hour is the creation of a comprehensive HSN [Harmonized System of Nomenclature] repository, with prompt resolution of grievances and export promotion initiatives by a centralised regulatory body, to give teeth to the sector.” He also added, “with limited attention being accorded, the sector’s full export potential cannot be achieved.”

Various countries do have some well-designed regulations for Nutraceuticals but lack of efficient implementation of these guidelines leading to fluctuating outcomes when compared with pharmaceutical sector.
Following are some of the suggestions if implemented can show some positive moves in regulatory framework of Nutraceutical:

• Globalization of guidelines: By executing a well-planned analysis ofexisting regulations employed in various countries and selecting the best approaches can achieve uniformity in regulatory framework worldwide. 
• Like Pharmacopeia, why not Nutracopeia? :An official publication containing a list of natural drugs with their effects, directions for use, tests, etc. can be generated to implement consistency in the regulatory field like pharmaceuticals. 
•  Implementation of transparency by governing bodies
• Risk assessment and verification technologies tied up with more solid inspections and stringent audits
• Like for pharmaceuticals, well-developed laboratories for effective testing and evaluation can be generated to maintain the standards of Nutraceuticals. 
• Internationalization of business to sustain the credibility of employed regulations. 
• Executing regular surveys to assess the degree of improvement 

A restructuring of the entire regulatory framework of Nutraceuticals is necessary to put forth their different purposes and universal definition.Also, to assess their specific role in the prevention and treatment of pathological conditions whichcan be proven by sound scientific and clinical data. A clear and shared regulation system that clearly indicates requirements for quality, efficacy, mechanism of action, safety and a better control can lead to higher quality productswhich could benefit potential consumers as well as the industry.
On the door of 2021, we can clearly see the bright future of life sciences industry ahead, but only when abide by updated regulations. Many more regulations are obliged to come with hidden procedural challenges for compliance. Manufacturers have to be awake with their eyes wide open while launching and marketing products in the presence of new and varying regulations. Keeping track of changing regulatory system is the only way to be updated and profited.
The article has been written by Dr. Smarta-CMD Interlink and published by Saffron Media.