The nutraceutical industry has three main segments, including herbal/-
natural products, dietary supplements and functional foods. The dietary supplements
market is preliminarily driven by the paradigm shift towards preventive
health management practices, amid rising healthcare costs and increasing burden
of lifestyle diseases. Rise in healthcare expenditure, increased usage of nutraceuticals
product as a substitute to prescription and OTC drugs and augmented demand
for the nutritional diet are the major factors driving the global nutraceuticals
market. Many individual laws were devised to govern its manufacturing and
sale. However, increasing regulatory formalities from multiple agencies and
laws, complicate the development, testing and marketing of these substances and
hamper the growth of the nutraceutical market. Globally, the regulatory authorities
are aware of the changing needs of consumers and proactively protect consumers
by amending existing laws to accommodate changes. Market entry requirements
of nutraceuticals, functional foods and supplements vary from country
to country. The global regulatory guidelines aim at regulating various aspects
of the nutraceutical and dietary supplements market, focusing on its manufacture,
testing, labeling, sale and registration to assure safety and quality of the
product. The major change that was introduced was the ban on marketing Nutraceuticals
as medicinal products. This review has been performed to provide a
comprehensive understanding of the global regulatory requirements with critical
analysis of the Indian regulatory guidelines to explore the lacunae and suggest
the need of further amendments in the form of recommendations that can be incorporated
into regulatory body guidelines to make it more competitive for national
& international trade.
Current regulatory guidelines and resources to support research of dietary supplements in the United States
