Current trends and regulatory aspects of nutraceutical: A comprehensive review

Abstract

In 1989, the Foundation for Innovation in Medicine (New York, US) created the term “nutraceutical†to name
the rapidly expanding area of biomedical research. Nutraceuticals are defined as food or dietary components that
offer medical or health benefits to the body, including disease prevention and treatment. Nutraceuticals are viewed
as a more natural way to achieve therapeutic effects with fewer side effects, and this perspective has transformed
the development and production of nutraceuticals into a multi‑billion‑dollar industry. The nutraceutical market is
expected to reach $1025 billion by 2030, with a CAGR of 8.33% from 2022 to 2030. Nutraceuticals are gaining
popularity due to their potential nutritional, safety, and therapeutic benefit. Current research has demonstrated that
these chemicals have potential results in a variety of complications. The regulatory status of nutraceuticals varies
by country or region. The food and drug administration (FDA) regulates nutraceuticals as dietary supplements
in the United States under the dietary supplement health and education act (DSHEA) of 1994. According to this
regulation, dietary supplements are products with one or more nutritional components, such as vitamins, minerals,
herbs, or other botanicals, that are meant to supplement the diet. Nutraceuticals do not require FDA pre‑market
approval under DSHEA, and the manufacturer is responsible for product safety and labeling. The FDA, on the
other hand, has the jurisdiction to investigate companies that make false or misleading statements about the
safety or effectiveness of their products. This article provides a brief overview of the nutraceuticals regulation
established by the US FDA in the United States and the Food Safety Standard Authority of India in India. Finally,
the nutraceutical industry is expanding rapidly, due to rising consumer awareness of the necessity of leading a
healthy lifestyle. Regulatory authorities around the world are responsible of guaranteeing the safety and efficacy
of nutraceuticals, and rules vary from country to country. As the market expands, it is critical for regulatory
agencies to stay ahead of the latest industry advancements to protect customer safety and trust.