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Inter-ministerial committee calls for amendment in FSS Act on nutraceuticals
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Friday, 15 November, 2024, 08 : 00 AM [IST]
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Gireesh Babu, New Delhi
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An inter-ministerial committee formed by the Union health ministry has recommended amendments to the Food Safety and Standards Act, 2006 and regulations on nutraceuticals and health supplements, to shift regulation of certain items to the drug regulatory authority and bring in standards including the Good Manufacturing Practices (GMP) for health supplements and nutraceuticals.
The committee, formed earlier this year under the chairmanship of the then health secretary Apurva Chandra to look into the regulatory purview of nutraceuticals in the country, recommended that in terms vitamins, minerals and amino acid supplements, the mere combination including single use of nutrients specified in Schedule-I of Nutra regulation may not be regulated by Food Safety & Standards Authority of India (FSSAI).
Vitamin, minerals and amino acids added in food (as defined in the FSS Act 2006) (containing macronutrients such as protein, carbohydrate and fat providing significant calories), may be retained under the purview of FSSAI, but the formulations having vitamins, minerals and amino acids with dose and/or dosage formats and permitted excipients as defined in rule D&C Act shall be shifted under the purview of Central Drugs Standard Control Organisation (CDSCO).
Section 22 (1) (a) &(b) of FSS Act, which defines the nutraceuticals and health supplements, need to be holistically re-examined in terms of the existing formats and in light of the amendments proposed. Suitable options may be explored to distinguish or define the formats clearly by obtaining legal opinion in the proposed amendments. Further amendment in Nutra regulations and in related regulations may be made subsequent to the amendment of the FSS Act, added the committee.
Observing that claims related to Disease Risk Reduction (DRR) are widely used by manufacturer without approvals and often misused or manipulated, the committee suggested that the claim to cure or mitigate any specific disease, disorder or condition including DRR shall be regulated by the CDSCO, while FSSAI may regulate only nutritional and health claims that are listed under FSS (Claims and Advertisements) Regulations, 2018. The DRR claims listed under this regulation may not be applicable for products categorised under nutraceutical regulations.
To strengthen the regulatory mechanism for claims, a provision has to be made to submit labels along with the claims and product at the time of licensing in appropriate regulations, it added.
FSSAI shall continue to regulate Food for Special Medical Purpose (FSMP) and Food for Special Dietary Uses (FSDU), with appropriate measures of risk assessment of safety and efficacy. However, FSDU shall be restricted to weight management, obesity, geriatric population pregnant and lactating women & sportsperson.
The disorders such as diabetes, high blood pressure, celiac disease, sleep management and other health conditions can be dealt with under FSMP. Nutra regulation may be amended to implement risk- appropriate measures of assessment of safety and efficacy in FSDU & FSMP product approvals, manufacturing and their surveillance.
Food containing added prebiotics and probiotics may continue to be regulated by FSSAI, while prebiotic and pure culture of probiotic with excipient base and dosage forms will not fall under the purview of the food authority and has to be regulated by the CDSCO.
A separate provision of GMP requirements for health supplements and nutraceuticals may be specified in FSS (Licensing and registration of food business) Regulations, 2011.
The committee also recommended that the products with botanicals, plants, molecules and extract making DRR claims could fall under the purview of the Ministry of Ayush, while these products without DRR claims may be regulated by FSSAI. FSSAI may also consider establishing a dedicated cell to monitor the advertisement for nutraceutical products, it added.
The recommendations are of importance to the consumers in the country, said Sumant Kumar Tiwari, joint director of the Jharkhand Drug Control Administration. He added that the consumer should familiarise themselves with the definition and uses of nutraceuticals - which can include dietary supplements, functional foods and other health products marketed for their health benefits.
The committee was formed by the Ministry to look into various regulatory challenges in the segment, including the regulation of vitamins and minerals, probiotic and prebiotics tablets and capsules, botanicals and plant extracts, claims, and pricing of nutraceuticals and health supplements.
For instance, vitamin levels defined for prophylactic dose and in some cases, for therapeutic dose were falling below one Recommended Dietary Allowances (RDA) and based on ICMR recommendation, the vitamins with doses upto one RDA are regulated under FSS Act. However, vitamin preparations having prophylactic and therapeutic claims should be regulated under the Drugs and Cosmetics Act, 1940 and Rules 1945, including Schedule V of the Rules. This has created an overlap of provisions under these two different acts.
Owing to this overlap, many companies shifted their products as health supplements to avoid the rigorous drug regulatory regime, observed the committee.
While the health supplements and similar products in India were regulated by the drug regulator earlier, in 2008, the FSSI was established and a significant shift happened in the regulation of food products, including health supplements, in India.
FSSAI introduced standards and regulations specifically tailored to ensure the safety and quality of food products, including nutraceuticals, health supplements etc. Since then, health supplements in India have been subject to regulatory oversight by FSSAI, including requirements for product licensing, labeling, quality control, and safety standards, it said. The committee also looked into existing regulations in various countries before coming out with recommendations.
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