A dietary supplement, also known as a nutraceutical, is regulated by FDA as a food. Dietary supplements are defined as products intended to supplement the diet that bear or contain one or more of the following dietary ingredients: (1) Vitamin; (2) Mineral; (3) Herb or other botanical; (4) Amino acid; (5) A dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (6) A concentrate, metabolite, constituent, extract, or a combination of any ingredient mentioned above. Dietary supplements are products intended for ingestion, are not represented for use as a conventional food or as a sole item of a meal or the diet, and are labeled as dietary supplements.
Intended use may be established through the following:
Statements on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a conventional food. Such claims establish the product as a drug because the intended use is to treat, cure, mitigate, or diagnose disease.
Consumer perception, which may be established through the product's reputation.
Ingredients that may cause the product to be considered a drug because the ingredient is well known to the public and industry to have therapeutic use.