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

Federal law — U.S. Code and appendices · legal_authorities

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

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Source file: Laws/federal/codes/united-states-code/title-21/section-350-vitamins-and-minerals--8abd36e9ff.md
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Source location: Title 21, Chapter 9, § 350; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(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,11 So in original. Probably should be “paragraph”. 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section343&num=0&edition=prelim) to be misbranded solely because its label bears, in accordance with [section 343(i)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section343/i/2&num=0&edition=prelim), 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321/ff&num=0&edition=prelim) (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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section343&num=0&edition=prelim). 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section343/j&num=0&edition=prelim) 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.

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Federal law — U.S. Code and appendices · legal_authorities

5 U.S.C. § 553 — Rule making

**(a)** This section applies, according to the provisions thereof, except to the extent that there is involved— (1) a military or foreign affairs function of the United States; or (2) a matter relating to agency management or personnel or to public property, loans, grants, benefits, or contracts. **(b)** General notice of proposed rule making shall be published in the Federal Register, unless persons subject thereto are named and either personally served or otherwise have actual notice thereof in accordance with law. The notice shall include— (1) a statement of the time, place, and nature of public rule making proceedings; (2) reference to the legal authority under which the rule is proposed; (3) either the terms or substance of the proposed rule or a description of the subjects and issues involved; and (4) the Internet address of a summary of not more than 100 words in length of the proposed rule, in plain language, that shall be posted on the Internet website under section 206(d) of the E-Government Act of 2002 ([44 U.S.C. 3501](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title44-section3501&num=0&edition=prelim) note) (commonly known as regulations.gov). Except when notice or hearing is required by statute, this subsection does not apply— (A) to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice; or (B) when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest. **(c)** After notice required by this section, the agency shall give interested persons an opportunity to participate in the rule making through subm

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 343 — Misbranded food

A food shall be deemed to be misbranded— **(a) False or misleading label** If (1) its labeling is false or misleading in any particular, or (2) in the case of a food to which [section 350 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350&num=0&edition=prelim) applies, its advertising is false or misleading in a material respect or its labeling is in violation of [section 350(b)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350/b/2&num=0&edition=prelim). **(b) Offer for sale under another name** If it is offered for sale under the name of another food. **(c) Imitation of another food** If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word “imitation” and, immediately thereafter, the name of the food imitated. **(d) Misleading container** If its container is so made, formed, or filled as to be misleading. **(e) Package form** If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, except that under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary. **(f) Prominence of information on label** If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and unde

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 343

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 350l — Mandatory recall authority

**(a) Voluntary procedures** If the Secretary determines, based on information gathered through the reportable food registry under [section 350f of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350f&num=0&edition=prelim) or through any other means, that there is a reasonable probability that an article of food (other than infant formula) is adulterated under [section 342 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342&num=0&edition=prelim) or misbranded under [section 343(w) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section343/w&num=0&edition=prelim) and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Secretary shall provide the responsible party (as defined in [section 350f of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350f&num=0&edition=prelim)) with an opportunity to cease distribution and recall such article. **(b) Prehearing order to cease distribution and give notice** (1) **In general** — If the responsible party refuses to or does not voluntarily cease distribution or recall such article within the time and in the manner prescribed by the Secretary (if so prescribed), the Secretary may, by order require, as the Secretary deems necessary, such person to— (A) immediately cease distribution of such article; and (B) as applicable, immediately notify all persons— (i) manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling such article; and (ii) to which such article has been distributed, transported, or sold, to immediately cease distribution of such ar

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350l

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Federal law — U.S. Code and appendices · legal_authorities

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

Page 124 TITLE 21—FOOD AND DRUGS § 350 1 So in original. Probably should be ‘‘paragraph’’. (June 25, 1938, ch. 675, § 410, as added Pub. L. 93–523, § 4, Dec. 16, 1974, 88 Stat. 1694; amended Pub. L. 104–182, title III, § 305, Aug. 6, 1996, 110 Stat. 1684.) Editorial Notes REFERENCES IN TEXT The Safe Drinking Water Act, referred to in subsec. (b)(4)(B)(ii), is title XIV of act July 1, 1944, as added Dec. 16, 1974, Pub. L. 93–523, § 2(a), 88 Stat. 1660, as amended, which is classified generally to subchapter XII (§ 300f et seq.) of chapter 6A of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under sec- tion 201 of Title 42 and Tables. AMENDMENTS 1996—Pub. L. 104–182 substituted ‘‘(a) Except as pro- vided in subsection (b), whenever’’ for ‘‘Whenever’’ and added subsec. (b). Statutory Notes and Related Subsidiaries BOTTLED WATER STUDY Pub. L. 104–182, title I, § 114(b), Aug. 6, 1996, 110 Stat. 1641, provided that not later than 18 months after Aug. 6, 1996, the Administrator of the Food and Drug Admin- istration would publish for public notice and comment a draft study on the feasibility of appropriate methods, if any, of informing customers of the contents of bot- tled water, and publish a final study not later than 30 months after Aug. 6, 1996. § 350. Vitamins and minerals (a) Authority and limitations of Secretary; appli- cability (1) Except as provided in paragraph (2)— (A) the Secretary may not establish, under section 321(n), 341, or 343 of this title, max- imum 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 nat- ural or synthetic vitamin or mineral (or com- bi

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 350

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