| Summary: | Food is the primary source of nutrients to keep us nourished and healthy. Poor and unhealthy diets implicated with the increase of several non-communicable diseases (NCDs) require a food-based approach to reduce the ongoing rise. Traditional knowledge and science behind food-related health benefits became evident in the last three decades. Active ingredients, bioactive molecules and conventionally used herbs were clinically researched and proven to have beneficial outcomes. In the Indian scenario, the multiplicity of food products, including medicinal type formats, such as health supplements, containing plant, herbs or novel ingredients, brings in a new complexity to regulations. Several of these ingredients are pharmacologically active substances and could overlap with drug regulations. The data generated on the nutritional and health benefit of a supplement should be reproducible, outcomes measurable and disease risk reduction shown by well-designed research studies. Regulatory challenges occur at several levels, namely, harmonization of law, fair trade practice, population exposures to chemicals and contaminants, food borne illness, rise in NCD's, novel ingredients, new technologies and a legacy of regulatory practice. While regulatory and legal challenges will always exist, reliance on the role of scientific research in the regulatory context becomes significant.
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