Recommendations for New Rules for Nutraceuticals: FSSAI

The introduction of GMP for health supplements and nutraceuticals aims to ensure product quality and consistency.

November 13, 2024

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Last Updated on November 13, 2024 by The Health Master

Nutraceuticals

In a significant move to bolster consumer safety and product quality, India’s health ministry has proposed amendments to the Food Safety and Standards Act, 2006 with respect to Nutraceuticals.

The inter-ministerial committee, tasked with streamlining the regulation of nutraceuticals and health supplements, has recommended a shift in regulatory oversight for certain products.

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Key Recommendations

Clearer Regulatory Boundaries: The committee proposes to distinguish between simple vitamin and mineral supplements and more complex formulations. The former would remain under FSSAI’s purview, while the latter, with specific dosages and excipients, would be regulated by the Central Drugs Standard Control Organisation (CDSCO).
Stricter Claims Regulation: To curb misleading claims, the committee suggests that only nutritional and health claims listed in the FSS (Claims and Advertisements) Regulations, 2018, can be made by FSSAI-regulated products. Disease Risk Reduction (DRR) claims would fall under CDSCO’s jurisdiction.
Enhanced Manufacturing Standards: The introduction of Good Manufacturing Practices (GMP) for health supplements and nutraceuticals aims to ensure product quality and consistency.
Categorizing Special Food Products: Food for Special Medical Purpose (FSMP) and Food for Special Dietary Uses (FSDU) will continue to be regulated by FSSAI, with specific categories and stricter oversight.
Balancing Traditional and Modern Medicine: Products with botanicals and plant extracts making DRR claims could fall under the Ministry of Ayush, while those without such claims would be regulated by FSSAI.

Must read: FSSAI: Food Labelling and Display

Why the Change?

The primary reasons behind these proposed changes include:

Overlapping Regulations: The current regulatory framework has led to confusion and inconsistencies, with products often falling into regulatory grey areas.
Misleading Claims: Many manufacturers have made exaggerated or unsubstantiated claims about their products, potentially harming consumers.
Quality Concerns: Ensuring the safety and efficacy of these products requires stringent quality control measures.

By implementing these recommendations, India aims to create a more robust and consumer-friendly regulatory environment for nutraceuticals and health supplements.

What are nutraceuticals and health supplements?

Nutraceuticals are food-based products that provide health benefits beyond basic nutrition.
Health supplements are products intended to supplement the diet with vitamins, minerals, or other nutrients.

How will these changes impact consumers?

The changes aim to protect consumers by ensuring the quality, safety, and efficacy of these products. Consumers can expect more reliable and trustworthy products in the market.

What should consumers look for when purchasing nutraceuticals and health supplements?

Consumers should look for products that are regulated by FSSAI or CDSCO, have clear labeling, and are manufactured by reputable companies. It’s also advisable to consult with healthcare professionals before starting any new supplement regimen.

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