FSSAI Suspends Licence and Prohibits Supplement Sale Over Unapproved Ingredients

The Food Safety and Standards Authority of India (FSSAI) has suspended a manufacturing licence and prohibited the sale of a dietary supplement, highlighting its focus on adherence to ingredient regulations and good manufacturing practices within the Indian supplement market. Matri Drinking Water, a food business operator, had its licence suspended by the FSSAI due to serious food safety violations related to packaged drinking water. Separately, the FSSAI prohibited the sale of the dietary supplement Venolex Forte, manufactured by Noble Healthcare. The FSSAI's decision follows findings that Venolex Forte contained ingredients with pharmacological effects, which are not permitted under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2022. ## Ingredient Non-Compliance The FSSAI identified Calcium Dobesilate, Diosmin, and *Euphorbia prostrata* as unapproved ingredients within Venolex Forte. Under the 2022 regulations, health supplements and nutraceuticals are subject to specific lists of permitted ingredients. The presence of substances with pharmacological activity, such as those identified, constitutes a violation of these provisions. ## Broader Enforcement Context These actions form part of a broader enforcement drive by the FSSAI across India. The regulator has recently taken similar measures against other food business operators. For example, products from Watawe Healthcare and Global Healthfit Retail India have faced bans due to issues including misleading claims and safety violations. Recent FSSAI activities have included product recalls, manufacturing licence suspensions, and sales prohibitions. Common violations leading to these enforcement actions include improper storage conditions, poor hygienic practices in manufacturing facilities, and the use of unapproved ingredients in product formulations. ## Regulatory Implications The FSSAI's consistent actions signal to manufacturers and brand owners operating within or exporting to the Indian market that compliance with the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2022, particularly regarding ingredient approval and permitted claims, is essential. Non-compliance may result in penalties, including licence suspensions and sales prohibitions. Industry stakeholders are advised to conduct due diligence on all ingredients used in formulations to ensure alignment with the FSSAI's current regulatory framework. The ongoing enforcement trend suggests continued scrutiny from the Indian regulator.