Дәрілік тағамдық қосымшалар: анықтама және реттеу мәселелері

Marketing term for supplement

Nutraceutical is a marketing term used to imply a pharmaceutical effect from a compound or food product that has not been scientifically confirmed or approved to have clinical benefits. In the United States, nutraceuticals are unregulated, existing in the same category as dietary supplements and food additives by the Food and Drug Administration (FDA), under the authority of the Federal Food, Drug, and Cosmetic Act. There are no internationally defined properties of nutraceuticals, referring 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."

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. 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 established requirements: foods should be (1) present in their naturally occurring form, rather than a capsule, tablet, or powder; (2) consumed in the diet as often as daily; and (3) should regulate a biological process in hopes of preventing or controlling disease.

Nutraceuticals have been considered as possible adjuncts to therapies for clinical disorders.

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 (approx. US$675 billion; 2023) by the year 2027.

The word "nutraceutical" is a portmanteau of the words "nutrition" and "pharmaceutical", coined in 1989 by Stephen L. DeFelice.

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.