A: The Food Safety and Standards Authority of India (FSSAI) is the primary regulatory body that governs nutraceuticals, health supplements, and functional foods in India under the Food Safety and Standards Act, 2006, and the FSS (Health Supplements, Nutraceuticals, etc.) Regulations, 2016 (as amended).

A: The FSSAI does not "approve" every standard product formulation with listed ingredients. The manufacturer is responsible for ensuring compliance with the regulations. However, prior product approval is mandatory if your product uses ingredients not listed in the FSSAI's approved schedules (Non-Specified Food - NSF), exceeds permissible daily limits (RDA), or makes specific health claims.

A: All Food Business Operators (FBOs) must obtain an FSSAI license. The type of license (Basic Registration, State License, or Central License) depends on factors such as annual turnover, production capacity, and whether you operate in a single state or multiple states. You can apply for a license via the online FoSCoS portal.

A: No. Nutraceutical products are categorized as food, not drugs. Therefore, labels and advertisements cannot make claims to diagnose, treat, cure, or prevent any human disease. Claims are restricted to structure/function claims (e.g., "supports bone health") or general well-being claims, which must be scientifically substantiated.

A: FSSAI mandates that all nutraceutical and health supplement labels must prominently display the statement "NOT FOR MEDICINAL USE" to clearly differentiate them from pharmaceutical drugs.

A: Ingredients must be sourced from the approved lists specified in various FSSAI schedules (e.g., Schedule IV for botanicals, Schedule VI for nutrients). You must ensure the quantity of nutrients does not exceed the Recommended Daily Allowance (RDA) limits set by the Indian Council of Medical Research (ICMR).

A: Such ingredients are considered "Non-Specified Foods" (NSF) in India and require a separate, rigorous pre-market product approval from the FSSAI. This process involves submitting detailed safety data, toxicological reports, and NABL-accredited lab results.

A: Yes, manufacturing must adhere to current Good Manufacturing Practices (GMP) and all local regulatory standards to ensure product quality, purity, and safety. Products in tablet/capsule/syrup formats must also meet the general quality requirements specified in recognized pharmacopoeias like the Indian Pharmacopoeia (IP).

A: Key mandatory information includes:
• The common name of the food (e.g., "Health Supplement")
• A "Supplement Facts" or nutritional information panel
• A declaration of active ingredients and their quantity per serving
• Recommended daily usage/dosage
• The mandatory "NOT FOR MEDICINAL USE" disclaimer
• Storage instructions and allergen information
• The FSSAI License Number and address of the manufacturer/relabeller.

A: The FSSAI regulations require specific warnings for certain ingredients (e.g., caffeine). Unless explicitly formulated as Food for Special Dietary Use (FSDU) for specific populations and labeled as such (sometimes requiring medical advice), health supplements are generally meant for persons above five years of age. We recommend consulting a healthcare professional before use, especially for vulnerable groups like pregnant/lactating women or children.

A: Our nutraceuticals are intended to supplement the diet and support general well-being, not to replace a balanced diet or medication. We strongly advise consulting a doctor or qualified healthcare professional before starting any new supplement, as interactions may occur.

A: The primary law is the Food Safety and Standards Act, 2006. The specific regulations are the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2022, all enforced by the Food Safety and Standards Authority of India (FSSAI).

A: Yes, all manufacturers, importers, and distributors must have an FSSAI license. Furthermore, if your product contains ingredients not listed in the FSSAI's approved schedules or uses novel processing methods, it requires specific pre-market "product approval" by the FSSAI.

A: Every package of nutraceutical-based food sold in India must prominently display the advisory warning: "NOT FOR MEDICINAL USE".

A: The FSSAI highly restricts the use of such absolute claims like "100% pure" or "100% natural" unless they can be scientifically and unequivocally substantiated. If such words are used in a brand name, a disclaimer may be required stating: "This is only a brand name or trade mark and does not represent its true nature".

A: Yes, absolutely. All claims must be truthful, unambiguous, and supported by scientific evidence. FSSAI and ASCI actively monitor claims across all platforms.

A: No. Any implied or direct disease-curing claims are strictly prohibited and may classify the product as a drug.

A: Non-compliance can lead to heavy fines, product recalls, license suspension or cancellation, and legal action.

A: Ingredients must be sourced from approved FSSAI schedules and comply with RDA limits set by ICMR. Prohibited substances are strictly not allowed.