“Nutraceutical” is a substance that may be considered a food or part of food that provides medical or health benefits, encompassing prevention and treatment of disease. Products as diverse as isolated nutrients, dietary supplements, and diets to genetically engineered “designer” foods, herbal products, and processed foods (cereals, soups, beverages) may be included under the umbrella of nutraceuticals. In India, nutraceuticals have been defined under Clause 22 of the Food Safety and Standards Act (FSSA), 2006. From a safety point of view, nutraceuticals are trusted products even if they are not approved by authorities like pharmaceuticals. With a lot of nutraceuticals, clinical studies have been carried out and results originating from these trials support their effectiveness as well as their general safety. Nutraceuticals are biologically active phytochemicals that possess health benefits. These may be delivered to the consumer as a dietary supplement and/or as a functional food. These products are likely to play a vital role in human health and longevity. The consumption of these products by the vast majority of the public is usually without a medical prescription and/or supervision. The impact of consumer confidence in the growth and survival of the dietary supplement industry is, therefore, direct and enormous. In recent years, the industry has suffered a setback in its growth, due to certain instances of quality failures and/or adverse health effects. This situation has created an urgency for increased regulatory oversight and for monitoring the products at various stages of manufacturing for quality and integrity. Development and implementation of safeguards – such as good manufacturing practice(s), TruLabel, quality certification, product reviews, and quality demonstration/verification – have since been intensified. Certain areas, such as raw material uniformity and traceability, good agricultural practices, and protection from bioterrorism, may still have the potential to impact the nutraceutical markets negatively. Recent improvements in the identification and standardization of botanical materials, coupled with screening by human cell line and gene expression-directed fractionation, are expected to expedite the development of new nutraceuticals and drugs.