Title 21, Food and DrugsRelease 119-110

§350 Vitamins and Minerals

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER IV — FOOD › § 350

Last updated Sep 23, 2026|Official source

Summary

Stops the federal food official from setting upper strength limits, from calling a vitamin or mineral a drug just because it is stronger than the official thinks is useful, and from restricting how many or which vitamins, minerals, or other ingredients can be put together in certain dietary foods. Those limits can still apply if the product is sold for treating or managing specific diseases or disorders, if it is sold for children (children means under the age of twelve years), or if it is sold for pregnant or breastfeeding women. Says these covered foods aren’t automatically treated as mislabeled just because they list ingredients or advertise ingredients that are not vitamins or minerals. Labels may not single out non‑dietary‑supplement ingredients except as part of the full ingredient list and only as rules require; special exceptions can be made if following that rule is impractical or unfair. Defines the covered foods as special dietary foods for people that contain vitamins or minerals and are meant to be taken in tablets, capsules, powders, softgels, gelcaps, or liquids, or that aren’t sold as ordinary food and aren’t sold as the only item of a meal or diet. Liquid form means a fluid taken in daily amounts measured in drops or similar small units. "Special dietary use" covers uses like medical or life‑stage needs (for example disease, pregnancy, infancy, allergies, underweight or overweight, or sodium control), to add vitamins or minerals to the diet, or to serve as the sole food in a diet.

Full Legal Text

Title 21, §350

Food and Drugs, Source: USLM XML via OLRC

(a)Authority and limitations of Secretary; applicability
(1)Except as provided in paragraph (2)—
(A)the Secretary may not establish, under section 321(n), 341, or 343 of this title, maximum limits on the potency of any synthetic or natural vitamin or mineral within a food to which this section applies;
(B)the Secretary may not classify any natural or synthetic vitamin or mineral (or combination thereof) as a drug solely because it exceeds the level of potency which the Secretary determines is nutritionally rational or useful;
(C)the Secretary may not limit, under section 321(n), 341, or 343 of this title, the combination or number of any synthetic or natural—
(i)vitamin,
(ii)mineral, or
(iii)other ingredient of food,
within a food to which this section applies.
(2)Paragraph (1) shall not apply in the case of a vitamin, mineral, other ingredient of food, or food, which is represented for use by individuals in the treatment or management of specific diseases or disorders, by children, or by pregnant or lactating women. For purposes of this subparagraph, the term “children” means individuals who are under the age of twelve years.
(b)Labeling and advertising requirements for foods
(1)A food to which this section applies shall not be deemed under section 343 of this title to be misbranded solely because its label bears, in accordance with section 343(i)(2) of this title, all the ingredients in the food or its advertising contains references to ingredients in the food which are not vitamins or minerals.
(2)The labeling for any food to which this section applies may not list its ingredients which are not dietary supplement ingredients described in section 321(ff) of this title (i) except as a part of a list of all the ingredients of such food, and (ii) unless such ingredients are listed in accordance with applicable regulations under section 343 of this title. To the extent that compliance with clause (i) of this subparagraph is impracticable or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary.
(c)Definitions
(1)For purposes of this section, the term “food to which this section applies” means a food for humans which is a food for special dietary use—
(A)which is or contains any natural or synthetic vitamin or mineral, and
(B)which—
(i)is intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form, or
(ii)if not intended for ingestion in such a form, is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet.
(2)For purposes of paragraph (1)(B)(i), a food shall be considered as intended for ingestion in liquid form only if it is formulated in a fluid carrier and it is intended for ingestion in daily quantities measured in drops or similar small units of measure.
(3)For purposes of paragraph (1) and of section 343(j) of this title insofar as that section is applicable to food to which this section applies, the term “special dietary use” as applied to food used by man means a particular use for which a food purports or is represented to be used, including but not limited to the following:
(A)Supplying a special dietary need that exists by reason of a physical, physiological, pathological, or other condition, including but not limited to the condition of disease, convalescence, pregnancy, lactation, infancy, allergic hypersensitivity to food, underweight, overweight, or the need to control the intake of sodium.
(B)Supplying a vitamin, mineral, or other ingredient for use by man to supplement his diet by increasing the total dietary intake.
(C)Supplying a special dietary need by reason of being a food for use as the sole item of the diet.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Amendments

1994—Subsec. (b)(2). Pub. L. 103–417, § 7(d), redesignated subpar. (A) as par. (2), substituted “dietary supplement ingredients described in section 321(ff) of this title” for “vitamins or minerals”, and struck out former subpar. (B), which read as follows: “Notwithstanding the provisions of subparagraph (A), the labeling and advertising for any food to which this section applies may not give prominence to or emphasize ingredients which are not— “(i) vitamins, “(ii) minerals, or “(iii) represented as a source of vitamins or minerals.” Subsec. (c)(1)(B)(i). Pub. L. 103–417, § 3(c)(1), inserted “powder, softgel, gelcap,” after “capsule,”. Subsec. (c)(1)(B)(ii). Pub. L. 103–417, § 3(c)(2), struck out “does not simulate and” after “in such a form,”.

Statutory Notes and Related Subsidiaries

Effective Date

of 1994 AmendmentFor provision that dietary supplements may be labeled after Oct. 25, 1994, in accordance with

Amendments

made by section 7(d) of Pub. L. 103–417, and shall be so labeled after Dec. 31, 1996, see section 7(e) of Pub. L. 103–417, set out as a note under section 343 of this title. Amendment of Inconsistent

Regulations

by Secretary Pub. L. 94–278, title V, § 501(b), Apr. 22, 1976, 90 Stat. 411, as amended by Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695, provided that: “The Secretary of Health and Human Services shall amend any regulation promulgated under the Federal Food, Drug, and Cosmetic Act [this chapter] which is inconsistent with section 411 of such Act [section 350 of this title] (as added by subsection (a)) and such

Amendments

shall be promulgated in accordance with section 553 of title 5, United States Code.”

Reference

Citations & Metadata

Citation

21 U.S.C. § 350

Title 21, Food and Drugs

Last Updated

Sep 23, 2026

Release point: 119-110