21 U.S.C. § 350

Vitamins and minerals

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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 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.(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 NotesAmendments

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 SubsidiariesEffective Date of 1994 Amendment

For 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.”

Notes of Decisions

Cited in 12 cases (2 in the last 5 years), 1977–2025 · leading case: United States v. Ten Cartons, Ener-B Nasal Gel, 888 F. Supp. 381 (E.D.N.Y 1995).

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United States v. Ten Cartons, Ener-B Nasal Gel, 888 F. Supp. 381 (E.D.N.Y 1995). · cites it 13× “Essentially, the defendant contended that Ener-B is a food because it functions as a “food for special dietary use” within the meaning of sec *386 tion 411 of the FDCA, 21 U.S.C. § 350 , which is the section governing the regulation of vitamins and minerals.”

Ball v. Takeda Pharm. Am., Inc., 963 F. Supp. 2d 497 (E.D. Va. 2013). “§ 20 (“Apples in Interstate Commerce”) and 21 U.S.C. § 350 (“Vitamins and Minerals”) as statutory bases for her negligence per se claim.”

Nat'l Nutritional Foods Ass'n v. Mathews, 557 F.2d 325 (2d Cir. 1977). · cites it 2× “2d 424 (1975), Congress enacted § 411 of the Act, 21 U.S.C. § 350 , which provides, in relevant part, that except as provided in paragraph (2): “(B) the Secretary may not classify any natural or synthetic vitamin or mineral (or combination thereof) as a drug solely because it…”

Free Speech Coalition, Inc. v. Holder, 957 F. Supp. 2d 564 (E.D. Pa. 2013). “21 U.S.C. §§ 350 (c), 373-374 (manufacturers of foods and drugs); 15 U.”

United States v. Undetermined Quantities of an Article of Drug Labeled as \Exachol\"", 716 F. Supp. 787 (S.D.N.Y. 1989). · cites it 2× “21 U.S.C. § 350 (c)(3)(A) applies the term “special dietary use” to a food which purports to be used by man to supply “a special dietary need that exists by reason of a physical, physiological, pathological or other condition, including but not limited to the condition of…”

Foster v. Georgia Bd. of Chiropractic Examiners, 359 S.E.2d 877 (Ga. 1987). “4 In addition, under certain circumstances, 21 USC § 350 (a) (1) (B) authorizes the Secretary of Health and Human Services to classify a vitamin, mineral, or food as a drug when represented for use by individuals in the treatment or mitigation of diseases or disorders.”

Nat'l Council for Improved Health v. Shalala, 893 F. Supp. 1512 (D. Utah 1995). “21 U.S.C. § 350 (a)(1)—(2). This provision of law effectively prohibits establishment of such potency limits.”

Mineral Resources Int'l v. United States Dep't of Health & Human Servs., 53 F.3d 305 (10th Cir. 1995). · cites it 2× “See generally 21 U.S.C. § 350 (c)(3)(A) [ (1988) ] and United States v.”

United States of Am. v. 250,000 Filled Bottles of Liquid Prod., more or less, of finished Prod., containing kratom, labeled in part: “Botanic Tonics Feel Free Plant Based Herbal Supplement,” 1.5 Tanks of Liquid Prod., more or less, containing kratom, 1,200 Cartons of Capsules, more or less, of kratom, labeled in part: “Botanic Tonics Feel Free Plant Based Herbal Supplement,” Undetermined Quantities of Bulk Powder Kratom, labeled in part: “Green Nano,” All Other Quantities of the Aforesaid Articles of Food, with any lot No. & in any size or type container that are labeled or otherwise appear to contain, or are, kratom, located at 13105 East 61st Street, Suites A&B Broken Arrow, Oklahoma 74012-1191 (N.D. Okla. 2025). · cites it 2× “First, Botanic Tonics argues that to sufficiently state a claim, the Amended Complaint must identify and address 21 U.S.C. § 350 (b). Dkt. No. 12 at 8. Section 350(b) provides certain exceptions to when a dietary supplement containing a new dietary ingredient is deemed…”

Farm & Ranch Freedom All. v. the Texas Dep't of Agric. & Sid Miller, in His Off. Capacity as Comm'r (Tex. App. 2025). “” See 21 U.S.C. § 350 (a)(1)(A). Produce safety is a key provision of the FSMA, and in 2016 the FDA promulgated its Produce Safety Rule, comprising Part 112 of Title 21 of the Code of Federal Regulations.”

Mary Hernandez, Individually & as Pers. Rep. of the Est. of Joseph Hernandez, & Sons, Carlos Cruz Hernandez & Jose Cruz Hernandez v. the Kroger Co. (Tex. App. 2015). “§ 301-357 and §341-350 (1-1), Annual Report for Congress; and (b) requiring actual in-store notices of Listeria, including failure to warn of Listeria and (c) failed to post country of origin where grown or imported from, outside the United States for 21 U.S.C. §350 (f)(g) and…”

Pharmanex, Inc. v. Shalala, 35 F. Supp. 2d 1341 (D. Utah 1999). “§ 321 (0(2), Cholestin is intended for ingestion in a capsule, a form described in 21 U.S.C. § 350 (c)(l)(B)(i). Accordingly, Cholestin fits within the definition of “dietary supplement” in 21 U.”

— 21 U.S.C. § 350(b) — 1 case

United States of Am. v. 250,000 Filled Bottles of Liquid Prod., more or less, of finished Prod., containing kratom, labeled in part: “Botanic Tonics Feel Free Plant Based Herbal Supplement,” 1.5 Tanks of Liquid Prod., more or less, containing kratom, 1,200 Cartons of Capsules, more or less, of kratom, labeled in part: “Botanic Tonics Feel Free Plant Based Herbal Supplement,” Undetermined Quantities of Bulk Powder Kratom, labeled in part: “Green Nano,” All Other Quantities of the Aforesaid Articles of Food, with any lot No. & in any size or type container that are labeled or otherwise appear to contain, or are, kratom, located at 13105 East 61st Street, Suites A&B Broken Arrow, Oklahoma 74012-1191 (N.D. Okla. 2025). “First, Botanic Tonics argues that to sufficiently state a claim, the Amended Complaint must identify and address 21 U.S.C. § 350 (b). Dkt. No. 12 at 8. Section 350(b) provides certain exceptions to when a dietary supplement containing a new dietary ingredient is deemed…”

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