Nutraceutical is a term that evolved scientifically and also through marketing which is used to imply a pharmaceutical effect from plant extracts, compounds, food products which have efficacy and therapeutic influence on clinical outcomes and patient care largely through supplements.
In the United States, nutraceuticals are considered and regulated as a subset of foods (such as dietary supplements) by the Food and Drug Administration (FDA). The same is widely accepted in Europe and parts of Asia and Africa.
Regulation
Nutraceuticals are treated differently in different jurisdictions.
Canada
Under Canadian law, a nutraceutical can be marketed as either a food or a drug; the terms nutraceutical and functional food have no legal distinction, as both refer to "a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food [and] is demonstrated to have a physiological benefit or provide protection against chronic disease".
United States
The term nutraceutical is not defined by the FDA. Depending on its ingredients and the claims with which it is marketed, a product is regulated as a drug, dietary supplement, food ingredient, or food. Companies have been fined by courts in India for failure to comply with quality control regulations.
Other sources
In the global market, there are significant product quality issues. Those marketing nutraceuticals internationally may claim their products contain certain ingredients, while the lack of regulation means there is no authority guaranteeing the accuracy of such claims, compromising the safety and effectiveness of such products. In the absence of regulation manufacturers and sellers can offer products of low quality or with ineffective or harmful ingredients.
Classification of nutraceuticals
Nutraceuticals are products derived from food sources that are purported to provide extra health benefits, in addition to the basic nutritional value found in foods. Depending on the jurisdiction, manufacturers and sellers may claim their products prevent chronic diseases, improve health, delay the aging process, increase life expectancy, or support the structure or function of the body.
Dietary supplements do not have to be approved by the FDA before marketing, but companies must register their manufacturing facilities with the FDA and follow current good manufacturing practices (cGMPs). In Japan, all functional foods must meet three requirements: foods must (1) be present in their naturally occurring form, rather than a capsule, tablet, or powder; (2) be consumed in the diet as often as daily; and (3) regulate a biological process in hopes of preventing or controlling disease.
Market
The modern nutraceutical market developed in Japan during the 1980s. In contrast to the natural herbs and spices used as folk medicine for centuries throughout Asia, the nutraceutical industry grew alongside the expansion of modern technology in the early 21st century.
The market for nutraceuticals is projected to grow to about 614 billion euros per year (approx. US$675 billion; 2023) by 2027.
Etymology
The word nutraceutical is a portmanteau of nutrition and pharmaceutical, coined in 1989 by Stephen L. DeFelice.
Criticism
Because nutraceuticals are unregulated, these supplements are sold by marketing hype rather than being based on actual clinical evidence. There is no compelling evidence for efficacy in nutraceuticals.
Some scientists point out that there are no internationally defined properties of nutraceuticals.