The FDCA defines a “dietary supplement” as a product (other than tobacco) intended for ingestion to supplement the diet that contains one or more of the following dietary ingredients (or a constituent/extract of these ingredients): vitamin, mineral, amino acid, concentrate, metabolite, herb or other botanical, substance to increase total dietary intake. Dietary supplements are FDA regulated as foods.
“(ff) The term “dietary supplement” –
- “(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
- “(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; or
- “(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);
- “(2) means a product that –
- “(A)(i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or
- “(ii) complies with section 411(c)(1)(B)(ii);
- “(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and
- “(C) is labeled as a dietary supplement; and
- “(3) does –
- “(A) include an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 402(f); and“(B) not include –
- “(i) an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or
- “(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,
- “(A) include an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 402(f); and“(B) not include –
which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act.