According to the Food Safety and Standards Regulations, 2015, Nutraceuticals have been defined as “Substances that are intended to furnish physiological benefits to the consumers and help nurture good health.” These can include capsules, chewables, powders and tablet forms and the regulations also specify that “a food business operator (FBO) may extract, isolate and purify nutraceuticals from both food and non-food sources.”
Key points from FSSAI regulations on nutraceuticals include:
- Definitions and Categories: FSSAI regulations clearly define nutraceuticals and categorize them into dietary supplements, health supplements, nutraceuticals, and foods for special dietary uses, among others. Each category has specific criteria and requirements.
- Ingredient Approval: Only ingredients that are approved and listed by FSSAI can be used in nutraceutical products. These ingredients must meet the safety and efficacy standards set by the authority.
- Labelling Requirements: Nutraceutical products must adhere to strict labelling regulations, including detailed information on ingredients, usage instructions, recommended dosages, and any potential health warnings. Labels must also highlight that the product is not intended to diagnose, treat, cure, or prevent any disease.
- Good Manufacturing Practices (GMP): Manufacturers of nutraceuticals are required to follow Good Manufacturing Practices (GMP) to ensure the quality, safety, and efficacy of their products. This includes maintaining hygiene, proper documentation, and regular quality checks.
- Scientific Evidence and Claims: Any health claims made about nutraceutical products must be backed by scientific evidence. Manufacturers must provide proof of efficacy and safety, including clinical trials or relevant studies, to substantiate their claims.
With more than 20 years of experience in supplement ingredients and products, FARE Labs provides a breadth of expertise in identification, potency, purity, and safety testing, as well as regulatory compliance. Our suite of nutraceutical testing services ranges from routine analysis to complex testing of natural ingredients in supplements and functional foods throughout their life cycle.