Classification
Product TypeProcessed Food
Product FormDietary supplement (capsule/tablet/powder)
Industry PositionNutraceutical / Health Supplement (consumer packaged goods)
Market
Quercetin supplements in India sit within the Food Safety and Standards Authority of India (FSSAI) framework for health supplements/nutraceuticals, where permitted ingredients and daily usage levels are schedule-based. FSSAI’s 2016 nutraceutical regulations explicitly list quercetin (from citrus fruits and other vegetables) with a maximum daily usage level, making dose-per-day labeling and formulation a primary compliance determinant. Imported quercetin supplements (and imported quercetin inputs used in India) face document scrutiny and risk-based inspection/sampling/testing through the FSSAI Food Import Clearance System (FICS) integrated with Customs single window. Marketing language is constrained by FSSAI advertising/claims rules and product-category rules that restrict disease prevention/treatment claims for nutraceuticals.
Market RoleDomestic consumer market for nutraceutical/health supplements with regulated ingredient-and-dose schedules; products may be domestically manufactured and/or imported under FSSAI controls
Domestic RoleOver-the-counter nutraceutical/health supplement sold as measured daily servings (e.g., capsules/tablets/powders) under FSSAI licensing, labelling, and claims controls
Risks
Regulatory Compliance HighIndia’s FSSAI nutraceutical schedule explicitly lists quercetin (from citrus fruits and other vegetables) with a maximum daily usage level of 100 mg/day; products formulated and labeled above the permitted daily usage level (or not aligned to the scheduled source/conditions) face high risk of non-compliance, enforcement action, or import refusal.Formulate and label serving directions so total daily quercetin intake does not exceed the scheduled maximum (100 mg/day), retain COA and test results that substantiate label claims, and run a pre-import/pre-launch regulatory review against the latest FSSAI schedules.
Marketing And Claims MediumDisease-related prevention/treatment/cure claims for nutraceuticals and misleading claims can trigger regulatory action under FSSAI nutraceutical category rules and the Advertising and Claims Regulations, including labeling and marketing communication scrutiny.Use only permissible structure/function-type claims supported by substantiation, avoid disease claims, and ensure label + advertisements pass a claims compliance checklist before release.
Import Clearance MediumImport clearance delays or rejection can occur due to missing/mismatched documentation (e.g., COA, label specimen, ingredient list, origin documents) and due to risk-based sampling/testing under FSSAI Import Regulations through FICS.Prepare a shipment-specific document pack aligned to FICS requirements (IEC, origin certificate, COA with safety parameters, label, ingredients, invoice/packing list) and validate label compliance before dispatch to reduce holds and NCR risk.
Food Safety MediumNon-compliance with contaminants limits (e.g., heavy metals) or other safety parameters can lead to non-conformance during testing and result in NCR and disposal/re-export outcomes under the import clearance process.Set incoming specifications aligned to FSSAI contaminants limits, require accredited-lab test reports for each lot (COA), and conduct periodic verification testing for heavy metals and relevant contaminants.
FAQ
What is the maximum daily quercetin level allowed for nutraceutical use in India?Under FSSAI’s 2016 nutraceutical regulations, quercetin (obtained from extracts of citrus fruits and other vegetables) is listed with a maximum daily usage level of 100 mg per day. Formulation and serving directions on the label should keep total daily intake within this limit.
Can quercetin nutraceutical products be sold in capsule or tablet form in India?Yes. FSSAI’s nutraceutical regulations allow nutraceuticals to be prepared and sold in formats such as granules, powder, tablet, capsule, liquid, jelly/gel and other measured-unit formats, excluding parenteral formats.
What documents are commonly required when importing quercetin supplements into India?FSSAI’s FICS importer FAQ highlights documents such as IEC (DGFT), FSSAI import license (as applicable), country of origin certificate, certificate of analysis including safety parameters (as applicable), ingredients list, specimen label, invoice/proforma invoice, packing list, and transport documents such as bill of lading (as applicable).