Health supplements being sold with claims of controlling diabetes, treating kidney ailments, detoxifying the liver and managing other diseases will face a major regulatory crackdown in Uttar Pradesh, with the Food Safety and Drug Administration (FSDA) prohibiting misleading disease-specific names and unsubstantiated medical claims on nutraceuticals.
The department has also made the declaration ‘Not for Medicinal Use’ mandatory on every pack, tightened restrictions on ingredients and dosage levels, and brought online marketplaces, advertisers, manufacturers and retailers within the ambit of enforcement.
In the case of herbal products, manufacturers can use only those plants and plant parts permitted under Schedule 4 of the applicable regulations. The restrictions will apply to products marketed in Uttar Pradesh, including those manufactured or imported from other states and Union Territories. The action follows an FSDA review that reportedly detected violations involving unauthorised ingredients, prescribed dosage limits, recommended dietary allowances (RDA), misleading product names, incorrect labelling and health-related claims without adequate scientific evidence. The department’s concern is that products legally classified as food are increasingly being marketed in a manner that makes consumers believe they can replace medicines or provide treatment for specific diseases. The order reiterates that nutraceuticals and health supplements cannot claim to diagnose, cure, prevent or treat any disease. Names such as ‘Diabetes Care’, ‘Arthritis Care’, ‘Kidney Care’, ‘Liver Detox’, ‘Cardio Care’, ‘Thyroid Care’, ‘Blood Sugar Control’ and ‘Disease Management’ have been identified as prohibited examples. The restriction is intended to prevent manufacturers from using product names and promotional language that create an impression of medical efficacy without regulatory approval or scientific substantiation. One of the key requirements is the mandatory declaration ‘Not for Medicinal Use’ in bold letters on every pack. The applicable product category must also be clearly mentioned on the packaging. The directions cover health supplements, nutraceuticals, foods for special dietary uses (FSDU), foods for special medical purposes (FSMP), probiotics and prebiotics. Manufacturers will have to disclose the active nutrients and their percentage contribution towards the recommended daily allowance prescribed by the Indian Council of Medical Research (ICMR). The FSDA has also restricted use of drugs, hormones, steroids, narcotic and psychotropic substances in health supplements, nutraceuticals, FSDU, FSMP, probiotics and prebiotics has been prohibited. Products specially formulated for sportspersons cannot contain substances included in the World Anti-Doping Agency’s (WADA) prohibited list. E-commerce platforms have been directed to take necessary steps to remove products that violate the prescribed requirements and stop their sale. Jacob has directed all food business operators to review their products, formulations, packaging, labelling and marketing practices to ensure compliance. She has directed FSDA to act against the manufacturers who don’t maintain records of permitted ingredients, formulations, batch manufacturing records (BMR), batch packaging records (BPR), certificates of analysis (COA) for raw materials and finished products, purity, stability, shelf life and quality-testing reports. Re-packers and re-labellers will be responsible for ensuring that the final packaging contains accurate information about ingredients, nutritional composition, permitted claims, mandatory warnings, original manufacturers and batch details.
The FSDA has specifically prohibited disease-based names and misleading medical claims on these products, according to Jacob. In a detailed order issued on Thursday, FSDA commissioner Roshan Jacob directed all food business operators to ensure strict compliance with statutory provisions governing health supplements, protein powders, vitamin and mineral supplements, herbal products, probiotics, prebiotics and nutraceuticals.
