Apex Panel Mulls Stricter Rules To Curb Misleading Claims By Nutraceuticals, Shifts Oversight From FSSAI
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In February, the government formed the panel to examine the possibility of bringing nutraceuticals under the ambit of CDSCO instead of food regulator FSSAI to address regulatory gaps
As India aims to cleanse and regulate the market of nutraceuticals, the top panel has recommended regulation of the advertisements of such products. (Getty)
A panel of experts has proposed that product labels and their claims be submitted at the time of applying for a licence to handle the issue of exaggerated health claims made by health supplements and nutraceuticals, News18 has learnt.
As India aims to cleanse and regulate the market of nutraceuticals, the top panel has recommended regulation of the advertisements of such products. It also says the Food Safety and Standards Authority of India (FSSAI) can consider examining the ads of nutraceuticals by establishing a “dedicated cell” for monitoring the content of promotion.
In February, the government formed the panel to examine the possibility of bringing nutraceuticals under the ambit of the apex drug regulatory authority, Central Drugs Standard Control Organisation (CDSCO), instead of food regulator FSSAI to address regulatory gaps, control the overstated claims and promote consumer safety.
According to the “report of the inter-ministerial committee to review the regulatory purview of nutraceuticals” accessed by News18, the panel has decided to shift certain products from FSSAI to CDSCO. For instance: The panel has proposed that FSSAI will continue to regulate foods for special dietary use (FSDU) and foods for special medical purposes.
However, the formulations having vitamins, minerals and amino acids with dosage format will move away from FSSAI to CDSCO.
The members of the inter-ministerial panel include Anita Praveen (secretary, Ministry of Food Processing Industries), Arunish Chawla (secretary, Department of Pharmaceuticals), Rajiv Bahl (director general, Indian Council of Medical Research), G Kamala Vardhana Rao (CEO, FSSAI), Atul Goel (Directorate General of Health Services), Rajeev Singh Raghuvanshi (Drug Controller General of India) and Rajesh Kotecha (secretary, Ministry of Ayush).
The panel is headed by Apurva Chandra, secretary of the Ministry of Health and Family Welfare.
20 pages, 7 sub-heads & multiple shifts from FSSAI to CDSCO
The committee — which met four times and discussed the overlapping issues between food and drugs — divided its 20-page report into seven subheads followed by a conclusion.
Further, the committee claimed that it invited different industry associations and discussed the impact of shifting industries of nutraceuticals from food to drugs.
The first subhead deals with ‘vitamins, minerals and amino acids supplements’ where the panel recommends that the mere combination including single use of nutrients specified in Schedule-I of Nutra regulation may not be regulated by FSSAI. It suggests “holistically re-examining” certain sections of the Food Safety and Standards Act of 2006.
The panel recommends that FSSAI can retain the vitamins, minerals and amino acids added in food containing macronutrients such as protein, carbohydrate and fat providing significant calories under its purview.
The second sub-head is about the “claims related to cure or mitigate any specific disease, disorder or condition including DRR (Disease Risk Reduction)”.
DRR refers to claims made by manufacturers that their products can lower the risk of developing certain diseases or health conditions. For example, a nutraceutical might claim that it helps reduce the risk of heart disease, diabetes, or cancer.
The panel recognises that “DRR claims are more widely used by manufacturers without approvals as well as these claims are manipulated in such a way that mimics treatment, cure, mitigation or prevention of any specific disease, disorder or condition in nutraceutical products”.
The panel proposes that FSSAI may regulate only nutritional and health claims that are listed under FSS (Claims and Advertisements) Regulations, 2018. It shifts the power to CDSCO to regulate the claims “to cure or mitigate any specific disease, disorder or condition including disease risk reduction (DRR)”.
Moving to the third subhead of “preparations of foods for special dietary use (FSDU) and foods for special medical purpose (FSMP)”, the panel proposes that FSSAI will continue to regulate this category with appropriate measures of risk assessment of safety and efficacy.
Foods for special dietary use will be restricted to weight management, obesity, geriatric population, pregnant and lactating women and sportspersons. “The disorders such as diabetes, high blood pressure, celiac disease, sleep management and other health conditions can be dealt under foods for special medical purpose.”
The panel has decided that regulation could be amended to tighten product approvals, manufacturing and surveillance of these products.
The fourth category of products under the segment is ‘prebiotic and probiotic with pure cultures in dosage forms”.
The panel recognised that “for more than a decade such products either alone or in combination with antibiotics, antibacterial, antidiarrheal, nutrient-based formulations have been regulated under drugs and cosmetics rules and licensed”.
The panel decided that the food containing added prebiotics and probiotics may continue to be regulated by FSSAI.
“The prebiotic and/or the pure culture of probiotic with excipient base and in the dosage forms as mentioned in D&C Act to be regulated by CDSCO and will not fall under the purview of FSSAI.”
In the fifth subhead, the panel recommends “Good Manufacturing Practices (GMP) for Nutraceuticals”. It expresses the need that a separate provision of GMP requirements for health supplements, nutraceuticals and similar products that may be specified in FSS Regulations, 2011.
The sixth subhead deals with botanicals, plants, isolates, molecules or extracts with ingredients of ayurvedic drugs. The panel suggests that these products making health claims should fall under the purview of the Ministry of Ayush including the regulation of claims.
But those without making disease risk reduction claims “may be regulated by FSSAI”. The seventh point is on “regulating advertisement for nutraceuticals” where the panel has recommended that “FSSAI may consider to examine the advertisement for nutraceutical products and establish a dedicated cell for its monitoring”.
Conclusion of the report
The panel report concludes by quoting “Let food be thy medicine and medicine be thy food”. It highlights that consumers are now “deeply concerned about how their health care is managed and administered”.
It confesses that the existing legislative efforts remain complex and not harmonised throughout the many regions of the globe. “The committee’s recommendations provide a clear demarcation in the regulatory landscape of the rapidly evolving health supplements, nutraceuticals and similar products.”
“It focuses on ensuring consumer safety, enhancing the ease of doing business for relevant stakeholders and improving the regulatory effectiveness.”
With these recommendations, the panel believes, “stakeholders can work towards a balanced regulatory environment that maximizes benefits and supports responsible industry practices.”
“These recommendations will build consumer confidence and decision-making, towards nutraceutical products.”
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