Supplement or drug: where does FSSAI's authority end?

Most 'is it banned' questions about supplements come down to one: is the product a food supplement or a drug? FSSAI's health supplement and nutraceutical regulations of 2022 answer it. Regulation 3(4) says these products shall not include a drug as defined in section 3 of the Drugs and Cosmetics Act. Regulation 3(5) says they may not contain hormones, steroids, psychotropic or NDPS substances, or items in Schedule E and E1 of the Drugs and Cosmetics Rules. The label must say 'NOT FOR MEDICINAL USE'.

Inside the line, the schedules list the permitted ingredients and their daily limits: for example melatonin at 2 to 10 mg, creatine at 3 g for adults, caffeine at 3 mg per kg of body weight, and ashwagandha root at 3 to 6 g. Outside it, a product is a drug question and belongs under the Drugs and Cosmetics Act and CDSCO.

The rules themselves are in an unusual position. FSSAI put them into operation by a direction of 30 Mar 2022 and re-operationalised them from 1 Apr 2023. We found no final gazette notification in 2025 or 2026. In Nov 2024 an inter-ministerial committee proposed that simple vitamins and minerals stay with FSSAI, complex formulations and disease-risk-reduction claims move to CDSCO, and botanicals with such claims go to AYUSH. That is a proposal, not law.