A Nutraceutical is a pharmaceutical-grade and standardized nutrient. In the USA, “nutraceuticals” do not exist as a regulatory category; they are regulated as dietary supplements and food additives by the FDA under the authority of the Federal Food, Drug, and Cosmetic Act.[
Under Canadian law, a nutraceutical can either be marketed as a food or as a drug; the terms “nutraceutical” and “functional food” have no legal distinction, 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 US law. 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.