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A nutraceutical or 'bioceutical' is a pharmaceutical alternative which claims physiological benefits. In the US, "nutraceuticals" are largely unregulated, as they exist in the same category 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."

In the global market, there are significant product quality issues. Nutraceuticals from the international market may claim to use organic or exotic ingredients, yet the lack of regulation may compromise the safety and effectiveness of products. Companies looking to create a wide profit margin may create unregulated products overseas with low-quality or ineffective ingredients.

A market research report produced in 2018 projected that the worldwide nutraceuticals market would account for over US$ 80,700 million in 2019, defining that market as "Dietary Supplements (Vitamins, Minerals, Herbals, Non-Herbals, & Others), and Functional Foods & Beverages".

In the United States, the Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the term: A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.

The word "nutraceutical" is a portmanteau of the words "nutrition" and "pharmaceutical", coined in 1989 by Stephen L. DeFelice, founder and chairman of the Foundation of Innovation Medicine. Indians, Egyptians, Chinese, and Sumerians are just a few civilizations that have used food as medicine. Let food be thy medicine. is a common misquotation attributed to Hippocrates, who is considered by some to be the father of Western medicine.

Because nutraceuticals and bioceuticals are largely unregulated, these supplements are the subject of more of marketing hype than actual clinical testing, and for many, it is not even yet known whether they provide more benefits than risks for consumers. For many of these products, the most compelling evidence for efficacy remains anecdotal or, at best, based on hints of benefit from small or poorly controlled studies. And when their claims do not match the evidence, there can be legal consequences. After scientists disputed the benefits of nutraceuticals like probiotics in Dannon yogurt, the company was forced to pay millions for falsely claiming its products Actimel and Activia boosted the immune system. Steven Nissen, chairman of cardiology at the Cleveland Clinic, said, "The concept of multivitamin supplements was sold to Americans by an eager nutraceutical industry to generate profits. There was never any scientific data supporting their usage."