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The Food and Drug Administration (FDA) is the governing regulatory body in the US for nootropics. Nootropics are considered a “food”, and more specifically, a dietary supplement. The 1994[1] amendment of the Federal Food, Drug, and Cosmetic Act (FD&C) with the passage of the Dietary Supplement Health and Education Act (DSHEA) defines a dietary supplement as:

  1. a food that would not conventionally be considered a meal, and
  2. (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake [e.g. enzymes, tissues from organs or glands]; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);

Supplements can take the form of tablets, gelcaps, capsule, powder, liquid, energy bars, etc.. The DSHEA sets a standard for supplement manufacturers dictating products’ ingredients, purity, strength, and composition[2].

Manufacturers’ claims (“structure-function” or “health” claims) generally fall into four categories[4]:

  1. describe how the supplement improves a classic nutrient deficiency with cited prevalence in the US;
  2. describe how the supplement affects structure or function in humans;
  3. describe the mechanism of action for the supplement; and
  4. describe the general well-being from consumption of the supplement

If the manufacturer’s claims fall within these four categories, the manufacturer must notify the FDA within 30 days of marketing the product as such. The manufacturer must have proof that 1) the claim is supported by data and research, and 2) the product is safe for consumption; however, the manufacturer does not have to provide this, nor any records or investigations regarding adverse events related to their product to the FDA. The onus falls on the FDA to show that the supplement has harmful effects[3]. The FDA requires that dietary supplement manufacturers append the following disclaimer to their claims:
“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease.”[4]


  1. ^ Dietary Supplements > Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues [Internet]. FDA: U.S. Food and Drug Administration; 2011 July [updated 2011 Jul 1]. Available from
  2. ^ FD&C Act Chapters I & II: Short Title and Definitions [Internet]. FDA: U.S. Food and Drug Administration; 1994 Oct 25 [updated 2009 Jul 13]. Available from
  3. ^ Percival S S. Dietary Supplements. In: Caballero B. Guide to Nutritional Supplements. Oxford, UK: Elsevier Ltd; c2009 [cited 2011 Dec 20]. [p. 367-80]. Excert available from: Google Books
  4. ^ Ross, S. Functional foods: the Food and Drug Administration perspective. The American Journal of Clinical Nutrition [Internet]. 2000 [cited 2011 Dec 20];71(suppl):1735S-8S. Available from:

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