§ 350. Vitamins and minerals

Footnotes

1. 1 So in original. Probably should be “paragraph”.

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   National Sickle Cell Anemia, Cooley’s Anemia, Tay-Sachs, and Genetic Diseases Act

   Pub. L. 94–278 title V § 501(a) · 90 Stat. 401

   Enacted · 21 U.S.C. § 350

   June 25, 1938, ch. 675, § 411, as added Pub. L. 94–278, title V, § 501(a), Apr. 22, 1976, 90 Stat. 410

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 411, as added Pub. L. 94–278, title V, § 501(a), Apr. 22, 1976, 90 Stat. 410

   Enacted provision · exact public law section
   (a) Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended by adding after section 410 (21 U.S.C. 349) the following new section: “Sec. 411. “vitamins and minerals (a) (1) Except as provided in paragraph (2)— “(A) the Secretary may not establish, under section 201(11), 401, or 403, 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 201 (n), 401, or 403, 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 “Children.” 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) (1) A food to which this section applies shall not be deemed under section 403 to be misbranded solely because its label bears, in accordance with section 403(i)(2), all the ingredients in the food or its advertising contains references to ingredients in the food which are not vitamins or minerals. “(2) (A) The labeling for any food tn which this section applies may not list its ingredients which arc not vitamins or minerals (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 403. 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. “(B) 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. “(c) (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, or liquid form, or “(ii) if not intended for ingestion in such a form, does not simulate and 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 403(j) insofar “Special dietary use.” 21 USC 343. 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 bi it 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.”.

2. 1994

   Dietary Supplement Health and Education Act of 1994

   Pub. L. 103–417 § 7(d) · 108 Stat. 4325

   1. Redesignated · 21 U.S.C. § 350(b)(2)

      Pub. L. 103–417, § 7(d), redesignated subpar. (A) as par. (2)

   2. Substituted · 21 U.S.C. § 350(b)(2)

      Pub. L. 103–417, § 7(d), substituted “dietary supplement ingredients described in section 321(ff) of this title” for “vitamins or minerals”

   3. Struck · 21 U.S.C. § 350(b)(2)

      Pub. L. 103–417, § 7(d), 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—

   Source evidence

   Code amendment note
   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.”

   Enacted provision · exact public law section
   (d) Vitamins and Minerals.— Section 411(b)(2) (21 U.S.C. 350(b)(2)) is amended— (1) by striking “vitamins or minerals” and inserting “dietary supplement ingredients described in section 201(ff)”; (2) by striking “(2)(A)” and inserting “(2)”; and (3) by striking subparagraph (B).

   Effective date note
   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.

3. 1994

   Dietary Supplement Health and Education Act of 1994

   Pub. L. 103–417 § 3(c)(1) · 108 Stat. 4325

   Inserted · 21 U.S.C. § 350(c)(1)(B)(i)

   Pub. L. 103–417, § 3(c)(1), inserted “powder, softgel, gelcap,” after “capsule,”

   Source evidence

   Code amendment note
   Subsec. (c)(1)(B)(i). Pub. L. 103–417, § 3(c)(1), inserted “powder, softgel, gelcap,” after “capsule,”.

   Enacted provision · exact public law section
   (1) in clause (i), by inserting “powder, softgel, gelcap,” after “capsule,”; and

   Effective date note
   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.

4. 1994

   Dietary Supplement Health and Education Act of 1994

   Pub. L. 103–417 § 3(c)(2) · 108 Stat. 4325

   Struck · 21 U.S.C. § 350(c)(1)(B)(ii)

   Pub. L. 103–417, § 3(c)(2), struck out “does not simulate and” after “in such a form,”

   Source evidence

   Code amendment note
   Subsec. (c)(1)(B)(ii). Pub. L. 103–417, § 3(c)(2), struck out “does not simulate and” after “in such a form,”.

   Enacted provision · exact public law section
   (2) in clause (ii), by striking “does not simulate and”.

   Effective date note
   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.

6 of 6 references resolved to an enrolled provision