Experts decode regulatory pathways for health supplements, nutraceuticals, ET HealthWorld
By Rashmi Mabiyan and Shilpasree Mondal
New Delhi: The health and wellness industry has made significant strides by incorporating modern technologies in health monitoring systems. These innovations are revolutionizing our monitoring, managing, and improving individual health. With AI enabling more accurate predictions and real-time analysis, the future of personal healthcare is becoming increasingly accessible and practical.
As the industry continues to evolve, focus is no longer only on technological innovation but also ensuring that products and services meet the regulatory standards of approval to boost consumer confidence.
At the ETHealthworld Nutriwell Conclave, a panel discussion titled ‘Decoding Regulatory Pathways for Health Supplements & Nutraceuticals’ featured prominent experts, including Dr. Manisha Shridhar, Regional Advisor, IP Rights, Trade and Public Health, SEARO WHO, Dr. Kavitha Ramasamy, Joint Director, Food Safety and Standards Authority of India, and Varsha Misra, Deputy Director, National Accreditation Board for Certification Bodies, QCI, Govt. of India. The panel was moderated by Pawan Kumar Agarwal, CEO, Food Future Foundation & Former CEO FSSAI.
The growing global demand for nutraceuticals and health supplements underscores the critical need for robust regulatory frameworks and reliable accreditation systems. These measures ensure the safety, efficacy, and quality of products that reach consumers. Highlighting the complexity of this task, Pawan Kumar Agarwal, CEO of the Food Future Foundation, remarked, “To ensure standards are met, we rely on a large ecosystem of players, including accreditation bodies and audit agencies.”
The discussion also delved into the distinctions between nutraceuticals and food supplements. Dr. Manisha Shridhar, Regional Advisor for IP Rights, Trade and Public Health at SEARO WHO, explained, “In the area of nutraceuticals if you are doing clinical trials, it is a nutraceutical because it is closer to drug regulation. But if we don’t have to do clinical trials, then it is into the food supplements area.” She highlighted that good manufacturing practices are essential for maintaining safety standards, as public health depends on stringent regulations.
Expanding on the regulatory challenges, Dr. Shridhar pointed out the absence of reference materials in the nutraceutical sector. She noted, “Unlike drugs, where we have a reference material…there’s no reference material because every product is new, and which is why the engagement with business and industry becomes even more critical.” She also praised the stringent regulatory mechanisms of the United States, where the Federal Trade Commission (FTC) ensures that claims about health products are accurate. She added, “If there is an iota of doubt in terms of public health, they can take action and withhold a product. So this is something that we need to keep in mind.”
In India, significant progress has been made under the Food Safety and Standards Act (FSS Act) and the Food Safety and Standards Authority of India (FSSAI). Dr. Kavitha Ramasamy, Joint Director at FSSAI, elaborated, “The regulations created clear distinctions between health supplements and nutraceuticals, establishing specific lists of permitted ingredients (e.g., vitamins, minerals, botanicals, extracts) with defined limits. This categorization ensures that products are properly regulated, with health supplements primarily being combinations of basic nutrients, and nutraceuticals containing more specialized ingredients like botanical extracts.” She also emphasized that exceeding the recommended dietary allowance (RDA) limits set by the Indian Council of Medical Research (ICMR) categorizes a product as a drug, adding another layer of consumer protection.
Accreditation also plays a pivotal role in the global acceptance of products. Varsha Misra, Deputy Director at the National Accreditation Board for Certification Bodies (QCI), Government of India, stressed the importance of accredited certifications: “In accreditation, we have a terminology. We call it accepted everywhere if it is certified, inspected, and tested by an accredited certification body.” She emphasized that certification systems must be accredited to ensure global recognition, adding, “Certification is important…but you have to ensure this certification must be accredited, and this accreditation is going to give you a hand hold across the world.”
The role of AYUSH was also discussed, particularly its establishment of clear categories for health products such as health supplements, prebiotics, probiotics, and foods for special dietary uses. Dr. Ramasamy noted, “Given that clear categories have been defined by AYUSH, such as health supplements, foods for special dietary uses, prebiotics, and probiotics, we can ensure better regulation and understanding in these areas.” These classifications aid in transparent and effective regulation.
Finally, Dr. Shridhar emphasized the importance of avoiding false claims, particularly for traditional medical products and those classified as food supplements in different jurisdictions. She stated, “We cannot make a false claim on a product, and this is where a lot of work is focused, particularly when it comes to Ayush and traditional medical products.” Concluding the discussion, Varsha Misra reiterated the global importance of accredited certification: “It is not just about having a certification; it’s about whether the certificate is tested and accredited. Only then will it be accepted globally.”
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