21 U.S.C. § 350 — Vitamins and minerals

(a) Authority and limitations of Secretary; applicability: (1) Except as paragraph (2) provides: (A) the Secretary may not use section 321(n), 341, or 343 to set maximum potency limits on any synthetic or natural vitamin or mineral within a food covered by this section; (B) the Secretary may not classify a natural or synthetic vitamin or mineral, or combination of them, as a drug solely because it exceeds a potency level the Secretary considers "nutritionally rational or useful"; (C) the Secretary may not use section 321(n), 341, or 343 to limit the combination or number of synthetic or natural vitamins, minerals, or other food ingredients within a food covered by this section. (2) Paragraph (1) does not apply to a vitamin, mineral, other food ingredient, or food that is represented for use in treating or managing specific diseases or disorders, for use by children, or for use by pregnant or lactating women. For this purpose, "children" means individuals under 12 years old. (b) Labeling and advertising requirements for foods: (1) A covered food is not automatically "misbranded" under section 343 just because its label lists all its ingredients (as section 343(i)(2) requires), or because its advertising refers to non-vitamin, non-mineral ingredients in the food. (2) The label for a covered food may not list ingredients that are not dietary supplement ingredients (as defined in section 321(ff)) except (i) as part of a complete ingredient list, and (ii) following the applicable labeling regulations under section 343. Where following requirement (i) is impractical or would result in deception or unfair competition, the Secretary may create exemptions by regulation. (c) Definitions: (1) A "food to which this section applies" is a food for humans intended for special dietary use that (A) is or contains a natural or synthetic vitamin or mineral, and (B) either (i) is intended to be swallowed as a tablet, capsule, powder, softgel, gelcap, or liquid, or (ii) if not intended for that kind of ingestion, is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet. (2) A food counts as intended for "liquid" ingestion under (1)(B)(i) only if it is formulated in a fluid carrier and meant to be taken in daily amounts measured in drops or similarly small units. (3) For paragraph (1), and for section 343(j) as it applies to these foods, "special dietary use" means a particular purpose a food is claimed or represented to serve, including but not limited to: (A) meeting a special dietary need caused by a physical, physiological, pathological, or other condition — including disease, convalescence, pregnancy, lactation, infancy, food allergies, being underweight or overweight, or the need to control sodium intake; (B) supplying a vitamin, mineral, or other ingredient to supplement someone's total dietary intake; or (C) supplying a special dietary need by serving as the sole item of the diet.