Dietary Supplement

What is a Dietary Supplement?

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.

What is intended use of a Dietary Supplement? 

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.

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