USA - Current trends and regulatory aspects of nutraceutical: A comprehensive review

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.

Author(s):  Singh, S., Bhardwaj., S and Singhal, S.

Published in: International Journal of Green Pharmacy