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New natural ingredients used in nutra
Wednesday, 20 September, 2023, 16 : 00 PM [IST]
Dr R K Sanghavi
The terminology ‘
Nutraceuticals’, more famously known as supplements, are derived by combining the words Nutrients + Pharmaceuticals. It was Dr Stephen DeFelice, the father of nutraceuticals, who thus derived the terminology in 1989. It was exact this same year that the author embarked upon his nutraceutical journey parallelly in India.

Regulations for nutraceuticals have evolved over the last three decades. The range of products was governed for over initial 15 years by the PFA (Prevention of Food Adulteration) Act. In 2006, the FSSA (Food Safety and Standards Act) was enacted and the same was implemented after another over half a decade by the FSSAI (Food Safety and Standards Authority of India).

FSSAI has standardised ingredients meaning that the nutraceutical products can only contain any from the various lists (schedules) under the FSS (Nutra), 2022. If any nutraceutical product is introduced in India having an ingredient, other than from ‘approved’ list separate specific clearance is given by FSSAI as a ‘novel’ ingredient.

India - FSSAI

Ingredients in nutraceuticals are natural compounds that offer health benefits beyond basic nutrition. Vitamins, minerals and amino acids / proteins constitute nutrients but the word ‘nutraceuticals’, in India, encompasses as per FSS (Food Safety and Standards) Regulations in the following categories:

    • Health Supplements (nutrients) - 75
    • Plants & Botanicals (Ayurceuticals) - 439
    • Other Molecules, Isolates & Extracts - 233
    • Prebiotics & Probiotics - 47

Standardisation implies that FSSAI, post-approval, will determine a safe and beneficial range for an ingredient, or insist on quality standards by specifying the concentration of its active content, for example – curcumin (‘haldi’) product standard is set by insisting upon the percentage desirable for its curcuminoids presence.

Global Nutraceuticals
The natural ingredients in nutraceuticals are either plant- or animal-based. The total number of ingredients derived globally from edible plant species is 250,000 – 3,00,000. Out of the 29,000 supplement products in USA, at least 44% contain animal sourced ingredient. The approving major regulatory bodies in the world for ingredients include:

    • Codex Alimentarius Commission (CAC) (also referred to as ‘Food Code’) – Food and Agriculture Organization (FAO) of United Nations / World Health Organization (WHO)
    • Joint FAO/WHO Expert Committee on Food Additives (JECFA) – FAO/WHO (provides risk assessment)
    • Dietary Supplement Health & Education Act (DSHEA) – USA
    • Generally Recognised As Safe (GRAS)– USA (provides safety assessment)
    • European Food Safety Authority (EFSA) – Europe
    • Food Standards Australia New Zealand (FSANZ) – Australia & New Zealand
    • Therapeutic Goods Administration (TGA) – Australia (regulates safety & quality)
    • China State Administration for Market Regulation (SAMR) – China
    • Foods for Specified Health Uses (FOSHU) – Japan
    • South African Health Products Regulatory Authority (SAHPRA) – South Africa
    • The Food Supplements (England/Scotland/Wales) and Addition of Vitamins, Minerals and Other Substances (England/Scotland/Wales) – Great Britain

All over the world, including in the developed and highly regulated countries and continents, nutraceuticals are available as Over-The-Counter (OTC) products.

New Natural Ingredients -  for India
OTC implies that any product approved / deemed safe anywhere in the world can be picked up from the shelf and consumed by a human be it an American, Britisher, European, Australian, African, Asian – including an Indian travelling overseas. There are 794 ingredients permitted in India under the nutraceuticals regulations by the FSSAI. However, globally there are a vast many more ingredients available in various OTC brands.

The enlightened Food Business Operators (FBOs) in India scout around globally for ‘novel’ ingredients that are proven beneficial in other countries but have escaped the FSSAI’s attention. In order to deliver the benefit of nutraceutical products with other than listed ingredients to the consumer, the FBOs are required to provide each time necessary voluminous documentation. Medically, the author being a qualified practising physician himself, it is always been a wonder why FSSAI needs to elaborate justify inclusion of a novel ingredient for introducing in India when nutraceuticals incorporating the same are freely available as OTC products overseas. After all, when ingredients not available in India are marketed as OTC products they have definitely been proven safe, besides being beneficial, by the listed various regulatory bodies of the country. And all humans, irrespective of nationality, have the same stomach and intestine (gastrointestinal tract) as well as blood flowing for absorption and assimilation of the active ingredient within the body tissues.

There needs to be amendment done in regulations under the concerned clauses if benefits of many nutraceutical ingredients are to be made available to the Indian population at their doorstep without the necessity of any consumer resorting to cumbersome procuring from the OTC shelf of another country.

There are never any restrictions for any consumer with respect to consuming a nutraceutical, irrespective whether the same is available in his/her own country. Also, there has never been reported a single known published side-effect of a particular OTC natural / complementary product because any of its active ingredient has reacted on account of ethnic differences in the humans.

Thus, there is a pressing need for the FSSAI to consider enlarging the list of approved nutrients, herbals and plant / animal based products (nutraceuticals) as well as prebiotics and probiotics within its various respective schedules of the FSS (Nutra) 2022 to be gazette regulations. It is suggested that the list of plant and animal – based nutraceuticals could be at the least in synchrony with Codex Alimentarius approved ingredients of the basis that, as per the FSSA 2006, whenever they Recommended Dietary Allowance (RDA) is not specified by the NIN (National Institute of Nutrition) / ICMR (Indian Council of Medical Research), the Codex RDAs are to be considered by default if specified under the same.

Another choker for approving novel ingredients is the FSS Act mentioning that unless any ingredient has been in use for over 30 years in the country of origin, or for 15 years in India itself, the same will not be considered for approving. This aspect of the Act needs to be modified suitably or else it would imply that any new ingredient introduced for the first time in an overseas market when one is a young adult in India, he / she will never be able to derive the benefit of that nutraceutical from a marketed product in India till old age overtakes!

(The author is sr consulting physician  consultant healthcare – nutra & pharma  medicomarketing & technoregulatory domains – OTC & ethical)
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