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- bination thereof) as a drug solely because it exceeds the level of potency which the Sec- retary determines is nutritionally rational or useful; (C) the Secretary may not limit, under sec- tion 321(n), 341, or 343 of this title, the com- bination or number of any synthetic or nat- ural— (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 dis- eases or disorders, by children, or by pregnant or lactating women. For purposes of this subpara- graph,1 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 sec- tion applies may not list its ingredients which are not dietary supplement ingredients de- scribed 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 com- pliance 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 syn- thetic vitamin or mineral, and (B) which— (i) is intended for ingestion in tablet, cap- sule, 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 ap- plicable 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, in- cluding but not limited to the following: (A) Supplying a special dietary need that ex- ists by reason of a physical, physiological, pathological, or other condition, including but not limited to the condition of disease, con- valescence, pregnancy, lactation, infancy, al- lergic 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 rea- son of being a food for use as the sole item of the diet. (June 25, 1938, ch. 675, § 411, as added Pub. L. 94–278, title V, § 501(a), Apr. 22, 1976, 90 Stat. 410; amended Pub. L. 103–417, §§ 3(c), 7(d), Oct. 25, 1994, 108 Stat. 4328, 4331.) Editorial Notes AMENDMENTS 1994—Subsec. (b)(2). Pub. L. 103–417, § 7(d), redesig- nated subpar. (A) as par. (2), substituted ‘‘dietary sup- plement ingredients described in section 321(ff) of this title’’ for ‘‘vitamins or minerals’’, and struck out Page 125 TITLE 21—FOOD AND DRUGS § 350a former subpar. (B), which read as follows: ‘‘Notwith- standing the provisions of subparagraph (A), the label- ing and advertising for any food to which this section applies may not give prominence to or emphasize ingre- dients which are not— ‘‘(i) vitamins, ‘‘(ii) minerals, or ‘‘(iii) represented as a source of vitamins or min- erals.’’ 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 AMENDMENT For provision that dietary supplements may be la- beled after Oct. 25, 1994, in accordance with amend- ments 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 Cos- metic Act [this chapter] which is inconsistent with sec- tion 411 of such Act [section 350 of this title] (as added by subsection (a)) and such amendments shall be pro- mulgated in accordance with section 553 of title 5, United States Code.’’ § 350a. Infant formulas (a) Adulteration An infant formula, including an infant for- mula powder, shall be deemed to be adulterated if— (1) such infant formula does not provide nu- trients as required by subsection (i), (2) such infant formula does not meet the quality factor requirements prescribed by the Secretary under subsection (b)(1), or (3) the processing of such infant formula is not in compliance with the good manufac- turing practices and the quality control proce- dures prescribed by the Secretary under sub- section (b)(2). (b) Requirements for quality factors, good manu- facturing practices, and retention of records (1) The Secretary shall by regulation establish requirements for quality factors for infant for- mulas to the extent possible consistent with current scientific knowledge, including quality factor requirements for the nutrients required by subsection (i). (2)(A) The Secretary shall by regulation estab- lish good manufacturing practices for infant for- mulas, including quality control procedures that the Secretary determines are necessary to as- sure that an infant formula provides nutrients in accordance with this subsection and sub- section (i) and is manufactured in a manner de- signed to prevent adulteration of the infant for- mula. (B) The good manufacturing practices and quality control procedures prescribed by the Secretary under subparagraph (A) shall include requirements for— (i) the testing, in accordance with paragraph (3) and by the manufacturer of an infant for- mula or an agent of such manufacturer, of each batch of infant formula for each nutrient required by subsection (i) before the distribu- tion of such batch, (ii) regularly scheduled testing, by the man- ufacturer of an infant formula or an agent of such manufacturer, of samples of infant for- mulas during the shelf life of such formulas to ensure that such formulas are in compliance with this section, (iii) in-process controls including, where necessary, testing required by good manufac- turing practices designed to prevent adultera- tion of each batch of infant formula, and (iv) the conduct by the manufacturer of an infant formula or an agent of such manufac- turer of regularly scheduled audits to deter- mine that such manufacturer has complied with the regulations prescribed under subpara- graph (A). In prescribing requirements for audits under clause (iv), the Secretary shall provide that such audits be conducted by appropriately trained in- dividuals who do not have any direct responsi- bility for the manufacture or production of in- fant formula. (3)(A) At the final product stage, each batch of infant formula shall be tested for vitamin A, vi- tamin B1, vitamin C, and vitamin E to ensure that such infant formula is in compliance with the requirements of this subsection and sub- section (i) relating to such vitamins. (B) Each nutrient premix used in the manufac- ture of an infant formula shall be tested for each relied upon nutrient required by subsection (i) which is contained in such premix to ensure that such premix is in compliance with its specifica- tions or certifications by a premix supplier. (C) During the manufacturing process or at the final product stage and before distribution of an infant formula, an infant formula shall be tested for all nutrients required to be included in such formula by subsection (i) for which test- ing has not been conducted pursuant to subpara- graph (A) or (B). Testing under this subpara- graph shall be conducted to— (i) ensure that each batch of such infant for- mula is in compliance with the requirements of subsection (i) relating to such nutrients, and (ii) confirm that nutrients contained in any nutrient premix used in such infant formula are present in each batch of such infant for- mula in the proper concentration. (D) If the Secretary adds a nutrient to the list of nutrients in the table in subsection (i), the Secretary shall by regulation require that the manufacturer of an infant formula test each batch of such formula for such new nutrient in accordance with subparagraph (A), (B), or (C). (E) For purposes of this paragraph, the term ‘‘final product stage’’ means the point in the manufacturing process, before distribution of an infant formula, at which an infant formula is homogenous and is not subject to further deg- radation. (4)(A) The Secretary shall by regulation estab- lish requirements respecting the retention of records. Such requirements shall provide for—